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Transkutana električna stimulacija živca (TENS) za neuropatsku bol kod odraslih

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Referencias

Barbarisi 2010 {published data only}

Barbarisi M, Pace MC, Passavanti MB, Maisto M, Mazzariello L, Pota V, et al. Pregabalin and transcutaneous electrical nerve stimulation for postherpetic neuralgia treatment. Clinical Journal of Pain 2010;26(7):567-72. CENTRAL

Bi 2015 {published data only}

Bi X, Lv H, Chen B, Li X, Wang X. Effects of transcutaneous electrical nerve stimulation on pain in patients with spinal cord injury: a randomized controlled trial. Journal of Physical Therapy Science 2015;27:23-5. CENTRAL

Buchmuller 2012 {published data only}

Buchmuller A, Navez M, Milletre-Bernardin M, Pouplin S, Presles E, Lantéri-Minet M, et al. Value of TENS for relief of chronic low back pain with or without radicular pain. European Journal of Pain 2012;16:656-65. CENTRAL

Casale 2013 {published data only}

Casale R, Damiani C, Maestri R, Wells CD. Pain and electrophysiological parameters are improved by combined 830-1064 high intensity LASER in symptomatic carpal tunnel syndrome versus transcutaneous electrical nerve stimulation. European Journal of Physical and Rehabilitation Medicine 2013;49:205-11. CENTRAL

Celik 2013 {published data only}

Celik EC, Erhan B, Gunduz B, Lakse E. The effect of low-frequency TENS in the treatment of neuropathic pain in patients with spinal cord injury. Spinal Cord 2013;51:334-7. CENTRAL

Gerson 1977 {published data only}

Gerson GR, Jones RB, Luscombe DK. Studies on the concomitant use of carbamazepine and clomipramine for the relief of post herpetic neuralgia. Postgraduate Medical Journal 1977;53(Suppl 4):104-9. CENTRAL

Ghoname 1999 {published data only}

Ghoname EA, White PF, Ahmed HE, Hamze MA, Craig WF, Noe CE. Percutaneous electrical nerve stimulation: an alternative to TENS in the management of sciatica. Pain 1999;83:193-9. CENTRAL

Koca 2014 {published data only}

Koca I, Boyaci A, Tutoglu A, Ucar M, Kocaturk O. Assessment of the effectiveness of interferential current therapy and TENS in the management of carpal tunnel syndrome: a randomized controlled study. Rheumatology International 2014;34:1639-45. CENTRAL

Nabi 2015 {published data only}

Nabi BN, Sedighinejad A, Haghighi M, Biazar G, Hashemi M, Haddadi S, et al. Comparison of transcutaneous electrical nerve stimulation and pulsed radiofrequency sympathectomy for treating painful diabetic neuropathy. Anesthesiology and Pain Medicine 2015;5(5):e29280. CENTRAL [DOI: 10.5812/aapm.29280]

Őzkul 2015 {published data only}

Őzkul C, Kilinc M, Yildirim SA, Topcuoğlu, Akyűz M. Effects of visual illusion and transcutaneous electrical nerve stimulation on neuropathic pain in patients with spinal cord injury: a randomised controlled cross-over trial. Journal of Back and Musculoskeletal Rehabilitation 2015;28:709-19. CENTRAL

Prabhakar 2011 {published data only}

Prabhakar R, Ramteke GJ. Cervical spine mobilization versus TENS in the management of cervical radiculopathy: a comparative experimental randomized controlled trial. Indian Journal of Physiotherapy and Occupational Therapy 2011;5(2):128-33. CENTRAL

Rutgers 1988 {published data only}

Rutgers MJ, Van Romunde LKJ, Osman PO. A small randomized comparative trial of acupuncture versus transcutaneous electrical neuro-stimulation in postherpetic neuralgia. Pain Clinic 1988;2(2):87-9. CENTRAL

Serry 2015 {published data only}

Serry ZMH, Mossa G, Elhabashy H, Elsayed S, Elhadidy R, Azmy R, et al. Transcutaneous nerve stimulation versus aerobic exercise in diabetic neuropathy. Egyptian Journal of Neurology, Psychiatry and Neurosurgery 2015;53(2):124-9. CENTRAL

Tilak 2016 {published data only}

Tilak M, Isaac SA, Fletcher J, Vasanthan LT, Subbaiah RS, Babu A, et al. Mirror therapy and transcutaneous electrical nerve stimulation for management of phantom limb pain in amputees - a single blind randomized controlled trial. Physiotherapy Research International 2016;21:109-15. CENTRAL

Vitalii 2014 {published data only}

Vitalii C, Oleg P. The efficiency of transcutaneous electrical nerve stimulation in association with gabapentin in the treatment of neuropathic pain in patients with spinal cord injury. Romanian Journal of Neurology 2014;13(4):193-6. CENTRAL

Al‐Smadi 2003 {published data only}

Al-Smadi J, Warke K, Wilson I, Cramp AFL, Noble G, Walsh DM, et al. A pilot investigation of the hypoalgesic effects of transcutaneous electrical nerve stimulation upon low back pain in people with multiple sclerosis. Clinical Rehabilitation 2003;17:742-9. CENTRAL

Bahtereva 2009 {published data only}

Bahtereva EV, Shirokov VA. Electrical nerve stimulation with sinusoidal modulated current therapy for pain deriving from double crash syndrome: efficacy evaluation trial. European Journal of Pain 2009;13:S55-S285. CENTRAL

Bloodworth 2004 {published data only}

Bloodworth DM , Nguyen BN, Garver W, Moss F, Pedroza C, Tran T, et al. Comparison of stochastic vs. conventional transcutaneous electrical stimulation for pain modulation in patients with electromyographically documented radiculopathy. American Journal of Physical Medicine and Rehabilitation 2004;83(8):584-91. CENTRAL

Bourke 1994 {published data only}

Bourke D. TENS vs placebo. Pain 1994;56(1):122. CENTRAL

Casale 1985 {published data only}

Casale R, Giordano A, Tiengo M. Spinal nociceptive reflex response. Changes in the RAIII nociceptive reflex response and in lumbo-sciatic pain induced by transcutaneous electrical nerve stimulation and vibrations [Risposte riflesse nocicettive spinali. Variazione della risposta riflessa nocicettiva RaIII e del dolore lombosciatalgico indotte da TENS e vibrazione]. Minerva Anestesiologica 1985;51:217-23. CENTRAL

Cheing 2005 {published data only}

Cheing GLY, Luk MLM. Transcutaneous electrical nerve stimulation for neuropathic pain. Journal of Hand Surgery, European Volume 2005;30B(1):50-5. CENTRAL

Chitsaz 2009 {published data only}

Chitsaz A, Janghorbani M, Shaygannejad V, Ashtari F, Heshmatipour M, Freeman J. Sensory complaints of the upper extremities in multiple sclerosis: relative efficacy of nortriptyline and transcutaneous electrical nerve stimulation. Clinical Journal of Pain 2009;25(4):281-5. CENTRAL

Connolly 2013 {published data only}

Connolly G. Pain in Multiple Sclerosis [PhD Thesis] theses.gla.ac.uk/5115/ (accessed 12 July 2016). Glasgow (UK): University of Glasgow, 2013. CENTRAL

Finsen 1988 {published data only}

Finsen V, Persen L, Lovlien M, Veslegaard EK, Simensen M, Gavann AK, et al. Transcutaneous electrical nerve stimulation after major amputation. Journal of Bone and Joint Surgery. British Volume 1988;70B:109-12. CENTRAL

Forst 2004 {published data only}

Forst T, Nguyen M, Forst S, Disselhoff B, Pohlmann T, Pfützner A. Impact of low frequency transcutaneous electrical nerve stimulation on symptomatic diabetic neuropathy using the new Salutaris® device. Diabetes, Nutrition and Metabolism 2004;17:163-8. CENTRAL

Franca 2013 {published data only}

Franca FR, Ramos LV, Burke TN, Caffaro RR, Marques AP. Lumbar stabilization and transcutaneous electrical nerve stimulation in lumbar disc herniation: preliminary study. Annals of the Rheumatic Diseases 2013;71:757. CENTRAL

Gossrau 2011 {published data only}

Gossrau G, Wahner M, Kuschke M, Konrad B, Reichmann H, Wiedemann B, et al. Microcurrent transcutaneous electric nerve stimulation in painful diabetic neuropathy: a randomized placebo-controlled study. Pain Medicine 2011;12:953-60. CENTRAL

Heidenreich 1988 {published data only}

Heidenreich VEM, Hentschel R, Lange A. Experiences with transcutaneous electrical nerve stimulation for the treatment of acute and chronic painful conditions [Erfahrungen mit der transkutanen elektrischen nervenstimulation zur behandlungakuter und chronischer schmerzzustande]. Physikalische Medizin Rehabilitationsmedizin Kurortmedizin 1988;40(6):389-96. CENTRAL

Ing 2015 {published data only}

Ing MR, Hellreich PD, Johnson DW, Chen JJ. Transcutaneous electrical nerve stimulation for chronic post-herpetic neuralgia. International Journal of Dermatology 2015;54:476-80. CENTRAL

Katz 1991 {published data only}

Katz J, Melzack R. Auricular transcutaneous electrical nerve stimulation (TENS) reduces phantom limb pain. Journal of Pain and Symptom Management 1991;6(2):73-83. CENTRAL

Kumar 1997 {published data only}

Kumar D, Marshall HJ. Diabetic peripheral neuropathy: amelioration of pain with transcutaneous electrostimulatIon. Diabetes Care 1997;20(11):1702-5. CENTRAL

Kumar 1998 {published data only}

Kumar D, Julka IS, Alvaro M, Marshall HJ. Diabetic peripheral neuropathy. Effectiveness of electrotherapy and amitriptyline for symptomatic relief. Diabetes Care 1998;21(8):1322-5. CENTRAL

Lehmkuhl 1978 {published data only}

Lehmkuhl G, Thissen R. The effectiveness of stimulation of skin receptors in the treatment of prolonged pain [Uber die wirksamkeit der stimulation von Hautrezeptoren bei der behandlung anhaltender Schmerzzustande]. Duetsche Medizinische Wochenschrift 1978;28:1141-3. CENTRAL

Marques 2014 {published data only}

Marques AP, Ramos LAV, Franca FJR, Callegari B, Burke TN, Magalhaes MO, et al. Effect of stabilizing exercises versus TENS in fatigue of the lumbar multifidus muscle and the ability to activate the transversus abdominis: a preliminary study. Annals of the Rheumatic Diseases 2014;17(Suppl 2):1222. CENTRAL

Mysliwiec 2012 {published data only}

Mysliwiec A, Saulicz E, Kuszewski M, Wolny T, Saulicz M, Knapik A. The effect of Saunders traction and transcutaneous electrical nerve stimulation on the cervical spine range of motion in patients reporting neck pain. Pilot study. Ortopedia Traumatologia Rehabilitacja 2012;14(6):515-24. CENTRAL

Norrbrink 2009 {published data only}

Norrbrink C. Transcutaneous electrical nerve stimulation for treatment of spinal cord injury neuropathic pain. Journal of Rehabilitation Research and Development 2009;46(1):85-94. CENTRAL

Oosterhof 2008 {published data only}

Oosterhof J, Samwel H, de Boo TM, Wilder-Smith OHG, Oostendorp RAB, Crul BJP. Predicting outcome of TENS in chronic pain: a prospective randomized placebo controlled trial. Pain 2008;136:11-20. CENTRAL

Pourmomeny 2009 {published data only}

Pourmomeny AA, Amini M, Safaei H, Hassanzadeh A. The effect of electroanalgesia on pain relief in patient with diabetic neuropathy type II. Iranian Journal of Endocrinology and Metabolism 2009;11(4):363-9. CENTRAL

Reichstein 2005 {published data only}

Reichstein L, Labrenz S, Ziegler D, Martin S. Effective treatment of symptomatic diabetic polyneuropathy by high-frequency external muscle stimulation. Diabetologia 2005;48:824-8. CENTRAL

Sherry 2001 {published data only}

Sherry E, Kitchener P, Smart R. A prospective randomized controlled study of VAX-D and TENS for the treatment of chronic low back pain. Neurological Research 2001;23(7):780-4. CENTRAL

Stepanovic 2015 {published data only}

Stepanovic A, Kolsek M, Kersnik J, Erculj V. Prevention of post-herpetic neuralgia using transcutaneous electrical nerve stimulation. Wiener Klinische Wochenschrift 2015;127:369-74. CENTRAL

Thorsteinsson 1977 {published data only}

Thorsteinsson G, Stonnington HH, Stillwell GK, Elveback LR. Transcutaneous electrical stimulation: a double-blind trial of its efficacy for pain. Archive of Physical Medicine and Rehabilitation 1977;58:8-13. CENTRAL

Warke 2004 {published data only}

Warke K, Al-Smadi J, Baxter GD, Walsh DM, Lowe-strong AS. Use of self-applied TENS for low back pain in people with multiple sclerosis. International Journal of Therapy and Rehabilitation 2004;11(6):275-80. CENTRAL

Warke 2006 {published data only}

Warke K, Al-Smadi J, Baxter D, Walsh D, Lowe-Strong A. Efficacy of transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain in a multiple sclerosis population. Clinical Journal of Pain 2006;22(9):812-9. CENTRAL

Wong 2016 {published data only}

Wong R, Major P, Sagar S. Phase 2 study of acupuncture-like transcutaneous nerve stimulation for chemotherapy-induced peripheral neuropathy. Integrative Cancer therapies 2016;15(2):153-64. CENTRAL

Yameen 2011 {published data only}

Yameen F, Shahbaz NN, Hasan Y, Fauz R, Abdullah M. Efficacy of transcutaneous electrical nerve stimulation and its different modes in patients with trigeminal neuralgia. Journal of Pakistan Medical Association 2011;61:437-9. CENTRAL

References to studies awaiting assessment

ICTRPNCT02496351 {published data only}

 

Samier 2006 {published data only}

Samier A. Neuropathic pain and transcutaneous electrical nerve stimulation (TENS) (effectiveness of TENS for 101 patients with chronic pain after 12 months follow up) [Douleurs neuropathiques et neurostimulation transcutanée (devenir et efficacité de la neurostimulation transcutanée à 1 an sur un échantillon de 101 patients douloureux chroniques consécutifs au sein des structures de prise en charge de la douleur chronique en Aquitaine)]. Thesis, University of Bordeaux2006. CENTRAL

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Baron R, Forster M, Binder A. Subgrouping of patients with neuropathic pain according to pain-related sensory abnormalities: a first step to a stratified treatment approach. Lancet Neurology 2012;11(11):999-1005.

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Bjordal JM, Johnson MI, Ljunggreen AE. Transcutaneous electrical nerve stimulation (TENS) can reduce postoperative analgesic consumption. A meta-analysis with assessment of optimal treatment parameters for postoperative pain. European Journal of Pain 2003;7(2):181-8.

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Brosseau L, Judd MG, Marchand S, Robinson VA, Tugwell P, Wells G, et al. Transcutaneous electrical nerve stimulation (TENS) for the treatment of rheumatoid arthritis in the hand. Cochrane Database of Systematic Reviews 2003, Issue 3. Art. No: CD004287. [DOI: 10.1002/14651858.CD004287.pub2]

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Brown L, Tabasam G, Bjordal JM, Johnson MI. An investigation into the effect of electrode placement of transcutaneous electrical nerve stimulation (TENS) on experimentally induced ischemic pain in healthy human participants. Clinical Journal of Pain 2007;23(9):735-43.

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Chesterton LS, Foster NE, Wright CC, Baxter GD, Barlas P. Effects of TENS frequency, intensity and stimulation site parameter manipulation on pressure pain thresholds in healthy human subjects. Pain 2003;106(1-2):73-80.

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Dowswell C, Bedwellc, Lavender T, Neilson JP. Transcutaneous electrical nerve stimulation (TENS) for pain management in labour. Cochrane Database of Systematic Reviews 2009, Issue 2. Art. No: CD007214. [DOI: 10.1002/14651858.CD007214.pub2]

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Johnson MI, Ashton CH, Thompson JW. An in-depth study of long-term users of transcutaneous electrical nerve stimulation (TENS). Implications for clinical use of TENS. Pain 1991;44:221-9.

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Johnson MI, Mulvey MR, Bagnall AM. Transcutaneous electrical nerve stimulation (TENS) for phantom pain and stump pain following amputation in adults. Cochrane Database of Systematic Reviews 2015, Issue 8. Art. No: CD007264. [DOI: 10.1002/14651858.CD007264.pub3]

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Johnson MI, Claydon LS, Herbison PG, Paley CA, Jones G. Transcutaneous Electrical Nerve Stimulation (TENS) for fibromyalgia in adults. Cochrane Database of Systematic Reviews 2016, Issue 4. Art. No: CD012172. [DOI: 10.1002/14651858.CD012172]

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Kalra A, Urban MO, Sluka KA. Blockade of opioid receptors in rostral ventral medulla prevents antihyperalgesia produced by transcutaneous electrical nerve stimulation (TENS). Journal of Pharmacology and Experimental Therapeutics 2001;298(1):257-63.

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Khadilkar A, Odebiyi DO, Brosseau L, Wells GA. Transcutaneous electrical nerve stimulation (TENS) versus placebo for chronic low-back pain. Cochrane Database of Systematic Reviews 2008, Issue 4. Art. No: CD003008. [DOI: 10.1002/14651858.CD003008.pub3]

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Leonard G, Goffaux, P, Marchand S. Deciphering the role of endogenous opioids in high-frequency TENS using low and high doses of naloxone. Pain 2010;151:215-9.

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Leonard G, Cloutier C, Marchand S. Reduced analgesic effect of acupuncture-like TENS but not conventional TENS in opioid-treated patients. Journal of Pain 2011;12(2):213-21.

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Maeda Y, Lisi TL, Vance CG, Sluka KA. Release of GABA and activation of GABA(A) in the spinal cord mediates the effects of TENS in rats. Brain Research 2007;1136(1):43-50.

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Matsuo H, Uchida K, Nakajima H, Guerrero AR, Watanabe S, Takeura N, et al. Early transcutaneous electrical nerve stimulation reduces hyperalgesia and decreases activation of spinal glial cells in mice with neuropathic pain. Pain 2014;155(9):1888-901.

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Rakel B, Cooper N, Adams HJ, Messer BR, Frey Law LA, Dannen DR, et al. A new transient sham TENS device allows for investigator blinding while delivering a true placebo treatment. Journal of Pain 2010;11(3):230-8.

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Somers DL, Clemente FR. Contralateral high or a combination of high- and low-frequency transcutaneous electrical nerve stimulation reduces mechanical allodynia and alters dorsal horn neurotransmitter content in neuropathic rats. Journal of Pain 2009;10(2):221-9.

Turk 2008

Turk DC, Dworkin RH, McDermott MP, Bellamy N, Burke LB, Chandler JM, et al. Identifying important outcome domains for chronic pain clinical trials: an IMMPACT survey of people with pain. Pain 2008;137(2):276-85.

van Hecke 2014

van Hecke O, Austin SK, Khan RA, Smith BH, Torrance N. Neuropathic pain in the general population: a systematic review of epidemiological studies. Pain 2014;155(4):654-62.

Vranken 2012

Vranken JH. Elucidation of pathophysiology and treatment of neuropathic pain. Central Nervous System Agents in Medicinal Chemistry 2012;12(4):304-14.

Wall 1967

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Walsh 2009

Walsh DM, Howe TE, Johnson MI, Moran F, Sluka KA. Transcutaneous electrical nerve stimulation for acute pain. Cochrane Database of Systematic Reviews 2009, Issue 2. Art. No: CD006142. [DOI: 10.1002/14651858.CD006142.pub2]

Wood 2008

Wood L, Egger M, Gluud LL, Schulz KF, Juni P, Altman DG, et al. Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study. BMJ (Clinical Research Ed.) 2008;336(7644):601-5. [PMID: 18316340]

References to other published versions of this review

Claydon 2014 (withdrawn)

Claydon LS, Chesterton L, Johnson MI, Herbison GP, Bennett MI. Transcutaneous electrical nerve stimulation (TENS) for neuropathic pain in adults. Cochrane Database of Systematic Reviews 2014, Issue 7. Art. No: CD008756. [DOI: 10.1002/14651858.CD008756.pub2]

Nnoaham 2014 (withdrawn)

Nnoaham KE, Kumbang J. Transcutaneous electrical nerve stimulation (TENS) for chronic pain. Cochrane Database of Systematic Reviews 2014, Issue 7. Art. No: CD003222. [DOI: 10.1002/14651858.CD003222.pub3]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Barbarisi 2010

Study characteristics

Methods

RCT, parallel design.

Participants

30 participants with postherpetic neuralgia, divided into 2 groups initially TENS (n = 16) and sham (n = 14). Each group further subdivided by concurrent dose of pregabalin. TENS group (pregabalin 300 mg, n = 9; pregabalin 600 mg, n = 7). Sham group (pregabalin 300 mg, n = 8; pregabalin 600 mg, n = 6). Baseline participant characteristics presented by gender not group.

Age (mean ± SD): men 65 ± 8.6 years; women 64 ± 8.2 years.

Pain duration: men 15.6 ± 8.8 months;

women: 14.9 ± 8.6 months.

Formal neuropathic pain assessment: no.

Sites of pain: left hemithorax: men 9, women 10; right hemithorax: men 3, women 4; leg: men 4, women 2; arm/forearm: men 4, women 4.

Concomitant treatment: all participants received pregabalin (300 mg or 600 mg) over initial 8 days' treatment until a pain intensity VAS of ≤ 60 mm was achieved. Following this, participants were randomised to TENS or sham. TENS/sham treatment continued for 4 weeks following randomisation. All participants continued with pregabalin treatment during the TENS/sham phase.

Interventions

TENS group: TENS 100 Hz (inconsistent description in text, later described as 50 Hz), 125 µs.

Intensity: "Clear non‐painful paraesthesia."

Sham TENS group: as per active TENS but no current passed through electrodes.

Sham credibility assessment: no.

Location: electrodes placed around site of pain.

Frequency of treatment: daily for 4 weeks.

Duration: 30 minutes per session.

Clinic administered.

Outcomes

Daily pain intensity.

0‐10 cm VAS.

Outcomes measured daily pretreatment and post‐treatment. VAS comparisons presented between baseline (day of randomisation to VAS group), week 3 and final VAS (post‐treatment completion ‐ week 4).

Did not report adverse events.

Notes

There may be mistakes in text of the article. VAS comparisons presented at 'week 3' and 'final' (week 4). It may be 'week 3' comparison is in fact 'week 4'. No conflict of interest stated.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer generated randomisation.

Allocation concealment (selection bias)

Unclear risk

Allocation concealment not reported.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Unclear risk for blinding of participants (TENS vs sham, attempted to manage participant expectations of sensation but no detail on whether TENS device appeared 'live' or not). Personnel high risk as the same care provider applied both active and sham treatments.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

TENS vs active sham but see comments above for blinding of participants.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No participant dropout after TENS group randomisation. No details regarding dropout during drug titration phase.

Incomplete outcome data (participant exclusion from analysis)

Low risk

No obvious exclusions and dropouts data described.

Selective reporting (reporting bias)

Unclear risk

Inconsistencies in data presentation. VAS pain data presented in text for week 3 post‐randomisation while data in tables presented for final (week 4) VAS

Other bias

Unclear risk

Baseline characteristics presented by gender not group characteristics.

Size of study

High risk

TENS group: n = 16; sham TENS group: n = 14.

Bi 2015

Study characteristics

Methods

RCT, parallel design.

Participants

52 participants with spinal cord injury. 4 dropouts, 2 per group. TENS: 17 men, 7 women; sham TENS

15 men, 9 women.

Age (mean ± SD): TENS 35 ± 9 years; sham TENS 33.6 ± 8.5 years.

Time since spinal cord injury (mean ± SD): TENS 7 ± 4.1 months; sham TENS 6.8 ± 3.1 months.

Formal neuropathic pain assessment: no.

Sites of pain: mixed.

Concomitant treatment: no details supplied.

Interventions

TENS group: TENS 2 Hz, 200 ms.

Intensity: 50 mA. No description of perceived sensation.

Sham TENS group: as per active TENS but no current passed through electrodes.

Sham credibility assessment: no.

Location: electrodes placed on region with pain.

Frequency of treatment: 3 times per week for 12 weeks.

Duration: 20 minutes per session.

Clinic administered.

Outcomes

Current pain intensity.

0‐10 cm VAS.

Outcomes measured at baseline (pretreatment) and immediately post‐treatment at 12 weeks.

Study did not report adverse events.

Notes

No conflict of interest stated.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer generated random number sequence.

Allocation concealment (selection bias)

Unclear risk

Allocation concealment not reported.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Unclear risk for blinding of participants (sham control but no attempt to manage participant expectations of sensation and no detail on whether TENS device appeared 'live' or not). Personnel high risk as the same care provider applied both active and sham treatments.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

TENS vs active sham but see comments above for blinding of participants.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Approximately 4% dropout balanced between groups.

Incomplete outcome data (participant exclusion from analysis)

Low risk

No obvious exclusions and dropout data adequately described.

Selective reporting (reporting bias)

Low risk

All outcomes adequately reported

Other bias

Low risk

Baseline characteristics comparable, outcome assessment times equal.

Size of study

High risk

n = 24 per group.

Buchmuller 2012

Study characteristics

Methods

RCT, parallel design.

Participants

236 participants divided into TENS group: 45 men, 72 women, sham TENS group: 43 men, 76 women, Neuropathic (radicular pain) subgroup n = 139. Of this neuropathic group, VAS pain intensity data provided by authors for radicular pain at baseline and post‐treatment for 122 participants (TENS group n = 64, sham TENS group n = 58). At 3 months, 38% dropout with TENS group n = 43, sham TENS group n = 32.

Age (mean ± SD): TENS group 52.0 ± 13 years for whole group. No data reported for neuropathic subgroup; sham TENS group 53.4 ± 12.9 years for whole group. No data reported for neuropathic subgroup.

Unable to determine duration of pain for neuropathic subgroup.

Formal neuropathic pain assessment: clinical assessment and DN4 ≥ 4.

Sites of pain: lower limb (radicular pain subgroup).

Concomitant treatment: no details supplied for neuropathic subgroup.

Interventions

TENS group: TENS mixed, 80‐100 alternated with 2 Hz, 200 ms.

Intensity: alternating low intensity paraesthesia with high intensity perceived sensation including muscle twitches.

Sham TENS group: as per active TENS but no current passed through electrodes.

Sham credibility assessment: no.

Location: 2 electrodes placed in low back area and 2 electrodes on radicular region.

Frequency of treatment: 4 treatment sessions per day for 3 months.

Duration: 1 hour per session.

Self‐administered.

Outcomes

Primary outcome: RDQ.

Secondary outcomes: pain and quality of life (SF‐36). Neuropathic subgroup outcomes reported as Pain reduction (3 months) and RDQ (6 weeks). No separate SF‐36 reported for neuropathic subgroup.

Pain recorded on 0‐10 cm VAS. Pain intensity data at baseline and post‐treatment supplied by authors for neuropathic group, specifically for the radicular pain component. VAS scored as weekly mean measures.

Outcomes measured at baseline (pretreatment) and immediately post‐treatment at 12 weeks.

Minor skin irritation in 14 participants.

Notes

Funding sources acknowledged and no conflict noted. Authors contacted with request for detailed data on pain intensity outcome measures for neuropathic subgroup and kindly provided these data.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer generated stratified randomisation.

Allocation concealment (selection bias)

Low risk

Central allocation.

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Participants blind (TENS vs sham, attempts made to manage participant expectations of sensation and the TENS device appeared 'live') and treatment self‐administered.

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Participants blinded, sham vs active TENS.

Incomplete outcome data (attrition bias)
All outcomes

High risk

At 3 months, 47 participants were missing from the original baseline data for participants with radicular pain. This represents a 38.5% dropout.

Incomplete outcome data (participant exclusion from analysis)

Unclear risk

No detail provided with respect to missing data and participant exclusion from analysis.

Selective reporting (reporting bias)

Unclear risk

Low risk for total study. Unable to assess for neuropathic subgroup and lack of SF‐36 data for neuropathic subgroup.

Other bias

Low risk

Baseline characteristics for total study well described.

Size of study

Unclear risk

Neuropathic subgroup: TENS group: n = 71; sham TENS group: n = 68.

Casale 2013

Study characteristics

Methods

RCT, parallel design.

Participants

20 participants with carpal tunnel syndrome. TENS group: 5 women, 5 men; laser group: 5 women, 5 men.

Age (mean ± SD): TENS group: 56.8 ± 12 years; laser group: 57.3 ± 12.9 years.

Duration of pain: no detail supplied.

Formal neuropathic pain assessment: nerve conduction study.

Sites of pain: hand.

Concomitant treatment: no details supplied.

Interventions

TENS group: TENS 100 Hz, 80 ms.

Intensity: "below muscle contraction," no details on perceived sensation.

Location: electrodes placed on carpal ligament and course of median nerve.

Frequency of treatment: daily for 3 weeks, 15 sessions in total.

Duration: 30 minutes per session.

Clinic administered.

Laser group: 250 J/cm2 25 W. Probe size 1 cm2.

Location: 10 cm length along course of median nerve in wrist area.

Frequency of treatment: daily for 3 weeks, 15 sessions in total.

Duration: 100 seconds per session.

Clinic administered.

Outcomes

Pain intensity: no further detail.

0‐10 cm VAS.

Outcomes measured at baseline (pretreatment) and post‐treatment at 3 weeks.

Study did not report adverse events.

Notes

No conflict of interest stated.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer aided sequence generation.

Allocation concealment (selection bias)

Unclear risk

No details supplied.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Both groups received an 'active' treatment.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Participants received active treatment in both groups.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No dropouts reported.

Incomplete outcome data (participant exclusion from analysis)

Low risk

No obvious exclusions from analysis.

Selective reporting (reporting bias)

Low risk

All stated outcomes reported.

Other bias

Low risk

Baseline characteristics between groups adequately tested and described.

Size of study

High risk

n = 10 per group.

Celik 2013

Study characteristics

Methods

RCT, parallel design.

Participants

33 participants with spinal cord injury. No participant dropout reported. TENS 4 men, 13 women; sham TENS 11 men, 5 women.

Age (mean ± SD): TENS group: 38.18 ± 9.86 years; sham TENS group: 34.81 ± 10.91 years.

Mean duration of pain (range): 19.1 (1‐170) months for whole sample. No further data supplied.

Formal neuropathic pain assessment: LANSS > 12.

Sites of pain: mixed; cervical and 'back', thigh, knee and foot.

Concomitant treatment: amitriptyline 10 mg both groups.

Interventions

TENS group: TENS 4 Hz, 200 µs.

Intensity: 50 mA. No description of perceived sensation.

Sham TENS group: as per active TENS but no current passed through electrodes.

Sham credibility assessment: no.

Location: electrodes placed around region with pain.

Frequency of treatment: 1 application per day for 10 days.

Duration: 30 minutes per session.

Clinic administered.

Outcomes

Pain intensity mean of morning, noon, evening and night VAS scores.

0‐10 cm VAS.

Outcomes measured at baseline (pretreatment) on day 1 and 1 day following treatment cessation (day 12).

Study reported adverse events and none occurred.

Notes

Baseline testing between group for difference in pain location, duration were reported as not being significantly different but no data provided. No description of baseline comparison for LANSS score. No conflict of interest stated.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

Alternate participant group allocation.

Allocation concealment (selection bias)

High risk

Alternate participant group allocation.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Low risk for blinding of participants (sham controlled study and no sensation reported from either active or sham device given participants had spinal cord injury). Personnel high risk as the same care provider applied both active and sham treatments.

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Participants blinded, sham vs active TENS.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No dropout of participants.

Incomplete outcome data (participant exclusion from analysis)

Low risk

No obvious exclusion from analysis.

Selective reporting (reporting bias)

Low risk

All outcomes adequately reported.

Other bias

Low risk

Baseline testing reported albeit without data presented for all tests.

Size of study

High risk

TENS group: n = 17; sham TENS group: n = 16.

Gerson 1977

Study characteristics

Methods

Randomised parallel design.

Participants

29 participants with postherpetic neuralgia. TENS group (n = 16), drugs group (n = 13). No detail on gender across groups. n = 10 dropouts in TENS group and n = 7 dropout in drugs group.

No baseline characteristics supplied for either group.

Formal neuropathic pain assessment: no.

Sites of pain: no details.

Concomitant treatment: no details.

Interventions

TENS group: no detail supplied for TENS application parameters or participant perceived intensity.

Location: 'Electrodes placed over the surface of the affected dermatome.'

Frequency of treatment: 1 TENS treatment session per week for 4 weeks then 1 treatment applied every second week for 3 weeks.

Duration: 15 minutes per session.

Clinic administered.

Drug group: carbamazepine plus clomipramine. No further detail supplied on dosage.

Duration of treatment: 8 weeks.

Outcomes

Pain intensity at each visit.

0‐10 cm VAS. No detail whether mean, current or maximal pain recorded at each visit.

Outcomes measured at baseline (pretreatment) day 0 then at weeks 2, 4, 6 and 8.

Study did not report adverse events.

Notes

Inconsistencies in text with respect to treatment protocol and duration. Data analysed on per protocol basis. No conflict of interest stated.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

No detail supplied.

Allocation concealment (selection bias)

Unclear risk

No detail supplied.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Given discrepancy in treatment types and application.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

As above.

Incomplete outcome data (attrition bias)
All outcomes

High risk

Approximately 60% dropout.

Incomplete outcome data (participant exclusion from analysis)

High risk

Per protocol analysis.

Selective reporting (reporting bias)

High risk

No variance in reported TENS data. Follow‐up data un‐interpretable.

Other bias

High risk

No baseline characteristics described.

Size of study

High risk

TENS group: n = 16; drug group: n = 13.

Ghoname 1999

Study characteristics

Methods

3 phase cross‐over study.

Participants

64 participants with lumbar radicular pain. 34 women and 30 men. No dropouts reported over entire study. Participants randomised to 3 treatment sequences 1: sham, PENS, TENS; 2: PENS, TENS, sham; and 3: TENS, sham, PENS.

Age (mean ± SD): 43 ± 19 years (of the whole sample).

Duration of pain (mean ± SD): 21 ± 9 months.

Formal neuropathic pain assessment: pain radiating below knee, positive straight leg raise testing. Radiological evidence of L5‐S1 nerve root compression.

Sites of pain: low back /leg, radicular pain.

Concomitant treatment: non‐opioid analgesia.

Interventions

Treatment sequence 1: sham, PENS, TENS.

Treatment sequence2: PENS, TENS, sham.

Treatment sequence3: TENS, sham, PENS.

TENS treatment: TENS 4 Hz, 100 ms.

Intensity: maximum tolerated amplitude without producing muscle contraction.

Location: 4 electrodes placed on posterior lower limb.

PENS treatment: 4 Hz, 100 ms.

Intensity: highest tolerable sensation without muscle contraction.

Location: 10 × 32G acupuncture needles inserted into posterior lower limb.

Sham PENS treatment: as per active PENS but no current passed through electrodes.

Sham credibility assessment: no.

Frequency of treatment: 3 applications per week for 3 weeks. 1 week washout between treatment modalities.

Duration: 30 minutes per session.

Clinic administered.

Outcomes

Pain intensity recorded at each visit and 24 hours after last treatment of each modality. Score reflected pain intensity during previous 24 hours. SF‐36 completed at baseline and 24 hours after last treatment session of each modality. NSAID use reported as change within modality.

0‐10 cm VAS for pain.

Study did not report adverse events.

Notes

SF‐36 and NSAID use appears to have been taken at initial baseline and then 24 hours following each treatment modality completion. No apparent testing for carry‐over effects on outcomes. Similar sham PENS was an invasive procedure compared to TENS. No conflict of interest stated.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

No details supplied.

Allocation concealment (selection bias)

Low risk

Cross‐over design.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Invasive vs non‐invasive treatment modalities.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Invasive vs non‐invasive treatment modalities.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Missing data or dropouts not reported over the multiple treatment contacts.

Incomplete outcome data (participant exclusion from analysis)

Low risk

Not applicable.

Selective reporting (reporting bias)

High risk

SF‐36 data not adequately reported or tested.

Other bias

Unclear risk

No formal assessment of carry‐over effects but data appeared very similar at baseline.

Size of study

Unclear risk

n = 64.

Koca 2014

Study characteristics

Methods

RCT, parallel.

Participants

75 participants with carpal tunnel syndrome equally to 3 treatment groups. 12 people dropped out during/follow‐up approximately evenly across groups. Splint group, 15 women, 7 men; TENS group 13 women, 7 men; IFT group 15 women, 6 men.

Age (mean ± SD): splint group: 35.4 ± 4.2; TENS group: 34.2 ± 5.2; IFT group: 34.9 ± 4.8 years.

Mean duration of pain: splint group: 12.4 ± 6.2; TENS group: 13.5.2 ± 6.6; IFT group: 13.0 ± 6.0 months.

Formal neuropathic pain assessment: positive nerve conduction studies.

Sites of pain: hand.

Concomitant treatment: paracetamol as required daily.

Interventions

Splint group: wrist‐hand resting splint at night for 3 weeks.

TENS group: TENS 100 Hz, 80 ms.

Intensity: no description of perceived sensation.

IFT group: 4000 Hz with base 20 Hz.

Intensity: no description of perceived sensation.

Location: electrodes for both modalities placed around palmar aspect of hand/wrist/thenar area.

Frequency of treatment: 5 times per week for 3 weeks.

Duration: 20 minutes per session.

Clinic administered.

Outcomes

Pain intensity: mean levels of pain in previous week.

0‐10 cm VAS.

Outcomes measured at baseline and 3 weeks after completion of treatment (6 weeks after randomisation).

2 participants in TENS group reported mild tenderness at application site.

Notes

No conflicts of interest stated.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

Sequential admission into study.

Allocation concealment (selection bias)

High risk

Sequential allocation.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Participant blinding was unclear if comparing TENS to IFT but high when comparing TENS to splint therapy. Personnel high risk as the same care provider applied both TENS and IFT treatments.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Participant blinding was unclear if comparing TENS to IFT but high when comparing TENS to splint therapy. Personnel high risk as the same care provider applied both TENS and IFT treatments.

Incomplete outcome data (attrition bias)
All outcomes

High risk

Participants lost to follow‐up specifically excluded.

Incomplete outcome data (participant exclusion from analysis)

High risk

Participants excluded if they failed to take part in the treatment regimen.

Selective reporting (reporting bias)

Low risk

Stated outcomes adequately reported.

Other bias

Unclear risk

Baseline characteristics tested and reported.

Size of study

High risk

n = 75 randomised across 3 treatment groups.

Nabi 2015

Study characteristics

Methods

RCT, parallel.

Participants

65 participants with diabetic neuropathy to 2 treatment groups, TENS and PRF sympathectomy. Overall, 10 participants (15%) described as having dropped out, however, sample sizes for both groups were stated as n = 30 (29 women, 31 men). Unable to accurately state gender composition of each group.

Age (mean ± SD): TENS group: 56.63 ± 5.86 years; PRF sympathectomy group: 56.76 ± 6.94 years.

Mean duration of diabetes: TENS group: 12.56 ± 2.96; PRF sympathectomy group: 13.32 ± 3.91.

Formal neuropathic pain assessment: no ‐ diagnosed by neurologist.

Sites of pain: lower limb.

Concomitant treatment: pregabalin 300‐600 mg.

Interventions

TENS group: TENS 80 Hz, appears to be 200 µs.

Intensity: 'two to three times sensory threshold."

Location: electrodes placed around shin and ankle.

Frequency of treatment: 10 treatment sessions delivered on alternate days.

Duration: 20 minutes per session.

Clinic administered.

PRF sympathectomy group: PRF sympathectomy delivered as one‐off invasive intervention.

Outcomes

Pain intensity: mean levels of pain in previous week.

0‐10 cm NRS.

Outcomes measured at baseline, 1 week, 1 month and 3 months following cessation of treatment (either one‐off PRF sympathectomy or 10 sessions of TENS on alternate days). Hence outcomes between groups were measured at differing time points postrandomisation.

"Skin irritation reported in a few TENS group subjects."

Notes

Supported by university funding.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Block randomisation.

Allocation concealment (selection bias)

Unclear risk

No detail supplied.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Clearly different treatments and 1 invasive.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Impossible to blind given the protocol.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Discrepancies in dropout and indicated analysis.

Incomplete outcome data (participant exclusion from analysis)

Unclear risk

Analysis not fully described and inconsistencies in dropout description.

Selective reporting (reporting bias)

Low risk

All outcomes reported.

Other bias

Unclear risk

Differences in time postrandomisation outcome measurement between groups.

Size of study

High risk

Reported as TENS group: n = 30; PRF sympathectomy group: n = 30.

Őzkul 2015

Study characteristics

Methods

Randomised cross‐over design.

Participants

26 participants with spinal cord injury to 2 treatment groups: 1. VI followed by TENS; 2. TENS followed by VI. n = 12 per group (2 participants dropped out). Total sample: 6 women, 18 men.

Age (mean ± SD): 32.33 ± 12.97 years.

Mean pain duration: 12.46 ± 17.83 months.

Formal neuropathic pain assessment: ≥ 4 on DN4.

Sites of pain: at or below level of spinal cord injury.

Concomitant treatment: pregabalin 300‐600 mg.

Interventions

TENS treatment: TENS 80 Hz, 180 µs.

Intensity: perceptible but not uncomfortable.

Location: electrodes placed bilateral spinal region above level of injury.

Frequency of treatment: 5 days per week for 2 weeks.

Duration: 30 minutes per session.

VI treatment: 20 minutes of VI treadmill walking.

Frequency of treatment: 5 days per week for 2 weeks.

Duration: 15 minutes per session.

Clinic administered.

Outcomes

Pain intensity: mean, maximal and minimal pain intensity levels. Brief pain inventory measured pretreatment and post‐treatment.

Pain 0‐10 cm VAS.

Outcomes measured at baseline, pretreatment and post‐treatment each treatment session/treatment modality.

Study reported adverse events and none occurred.

Notes

No carry‐over tests reported. No baseline comparisons between groups reported. No conflict of interest stated.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Table of random numbers.

Allocation concealment (selection bias)

Low risk

Cross‐over.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Both active non‐invasive treatments.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

As above.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Dropout from study described and minimal.

Incomplete outcome data (participant exclusion from analysis)

Low risk

Appears adequate.

Selective reporting (reporting bias)

Low risk

Adequately reported.

Other bias

Unclear risk

No formal assessment of carry‐over effects but data appeared very similar at baseline.

Size of study

High risk

n = 12 per group.

Prabhakar 2011

Study characteristics

Methods

RCT, parallel design.

Participants

75 participants with cervical radicular pain. No participant dropout reported. Randomised into 3 groups: joint mobilisation, TENS and isometric exercises. No details supplied on individual group size or gender composition. Whole sample 48% women, 52% men. Between‐group baseline tests for age, body mass and pain duration reported as "homogenous;' no formal statistical testing.

Age (mean ± SD): Group A: 36.33 ± 9.4 years; Group B: 37.25 ± 9 years; Group C: 39.33 ± 8.6 years.

Mean duration of pain: no data supplied.

Formal neuropathic pain assessment: no.

Sites of pain: cervical spine and unilateral upper limb pain.

Concomitant treatment: heat packs applied to the cervical spine area.

Interventions

Joint mobilisation group: cervical spine lateral flexion joint mobilisation, 10 sessions on alternate days over 3 weeks.

TENS group: TENS 100 Hz, 50 µs. Intensity: no detail supplied, 10 sessions on alternate days over 3 weeks, 30 minute per session. Electrodes placed at cervical spinal segment and distal dermatomal area.

Exercise group: isometric neck exercises: isometric flexion, lateral flexion, rotation and extension. 6‐8 seconds per contraction. 5 repetitions for each muscle group. No details on intensity of contraction. 10 sessions on alternate days over 3 weeks.

All treatments administered/supervised in clinic.

Outcomes

Pain intensity. No details on pain intensity instructions with respect to current pain, mean pain, etc.

0‐10 cm VAS.

Outcomes measured at baseline (pretreatment) week 3 and week 6 (3 weeks post‐treatment finished).

Study did not report adverse events.

Notes

Week 3 VAS results were reported as reduction from baseline. Unable to extract baseline data. Week 6 data not reported in text. No conflict of interest stated.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

No details supplied.

Allocation concealment (selection bias)

Unclear risk

No details supplied.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

2 active non‐invasive treatments.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

As above in terms of active treatments.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

No details supplied.

Incomplete outcome data (participant exclusion from analysis)

Unclear risk

No details supplied.

Selective reporting (reporting bias)

High risk

Key baseline data and week 6 data not supplied.

Other bias

High risk

Baseline group characteristic testing not described. Age and pain duration at baseline described as homogenous.

Size of study

High risk

Unknown sample size per group. Whole group: n = 75.

Rutgers 1988

Study characteristics

Methods

Randomised parallel design.

Participants

26 participants with postherpetic neuralgia to 2 treatment groups: TENS group (n = 13) and ACU group (n = 10). At 6 months, 13 dropouts in TENS group and 9 dropouts in ACU group. Total sample = 13 women, 10 men.

Age (median (range)): 73 (57‐85) years.

Mean pain duration: 3 months to > 9 years.

Formal neuropathic pain assessment: no.

Sites of pain: mixed.

Concomitant treatment: no details supplied.

Interventions

TENS group: TENS 100 Hz, 200 µs.

Intensity: amplitude increased until 'a fairly strong sensation' was perceived.

Location: electrodes placed either side of painful area.

Frequency of treatment: 3 clinic administered 30 minute treatments in first week. Then TENS unit loaned for home use for 5 weeks. No information regarding frequency of use given for this period.

ACU group: 2 treatment session per week for 6 weeks. Body and auricular stimulation. Steel needles stimulated with current at 5‐60 Hz.

Duration: no details supplied.

Clinic administered.

Outcomes

Pain intensity, visual stepwise scale, 10 steps. Measured at intake, 6 weeks, 9 weeks and 6 months. No details supplied as to parameters of pain rating (current pain, mean pain, etc.).

Study did not report adverse events.

Notes

No formal statistical tests employed. At 9 weeks, study had 7 participants left in study (73% dropout). Private funding body acknowledged.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

No details supplied.

Allocation concealment (selection bias)

Unclear risk

No details supplied.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

TENS vs invasive treatment.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Impossible due to treatments being compared.

Incomplete outcome data (attrition bias)
All outcomes

High risk

> 70% dropout at 9 weeks.

Incomplete outcome data (participant exclusion from analysis)

High risk

No final statistical tests performed but appears a per protocol approach.

Selective reporting (reporting bias)

High risk

No data supplied for outcomes.

Other bias

Unclear risk

No baseline data supplied.

Size of study

High risk

TENS group: n = 10; ACU group: n = 13.

Serry 2015

Study characteristics

Methods

Randomised parallel design.

Participants

60 participants with chronic DPN were randomised to 3 treatment groups: TENS group n = 20, exercise group n = 20, pharmacological group n = 20. In the total sample, there were 32 women and 28 men.

Age (mean ± SD): TENS group: 51.6 ± 4.75 years; exercise group: 51.7 ± 4.44 years; pharmacological group: 51.95 ± 4.38.

Mean duration of DPN: TENS group: 12.05 ± 3.17; exercise group: 12.15 ± 0.38; pharmacological: 12.3 ± 3.38 (unit of measurement not stated).

Formal neuropathic pain assessment: no, diagnosed clinically.

Sites of pain: lower limb.

Concomitant treatment: all groups continued with "regular pharmacological therapy." There was no description of this for TENS and exercise group in either drugs or dosage. However, the pharmacological group (regular therapy) was described as consisting of "nerve growth stimulant; vitamin B complex and oral hypoglycaemic drugs or insulin." No further details or comparisons made between groups in this area.

Interventions

TENS group: TENS 15 Hz, 250 µs.

Intensity: increased until "strong rhythmic muscle contractions" observed.

Location: 2 electrodes placed bilaterally on lower aspect of medial tibial condyle and superior to medial malleolus.

Frequency of treatment: 3 days per week for 8 weeks.

Duration: 30 minutes per session.

TENS treatment clinic administered.

Exercise group: aerobic exercise on stationary bicycle.

Intensity: following warm‐up, participants exercised at 50‐70% of maximal heart rate.

Frequency of treatment: 3 days per week for 8 weeks.

Duration: 50 minutes per session (5 minutes' warm‐up, 40 minutes' exercise, 5 minutes' cool down).

Pharmacological group: "regular therapy." No further information supplied.

Outcomes

Pain intensity recorded pretreatment and post‐treatment on a 0‐10 VAS. No detail supplied with respect to parameter measured with VAS (e.g. mean pain, minimal pain, maximal pain, etc.). Nerve conduction studies of medial plantar sensory nerve performed pretreatment and post‐treatment.

Study did not report adverse events.

Notes

Data not supplied for concomitant drug treatment. No data supplied for baseline or post‐treatment pain intensity scores. Paper stated Kruskal‐Wallis testing was used to assess between‐group differences in pain intensity scores post‐treatment; however, this analysis was not reported. All significant pain intensity findings are based on within‐group analysis and no detail on output of these tests supplied. Pain intensity only presented in descriptive form; percentage change from baseline. Have contacted authors regarding pain intensity data.

No conflict of interest reported.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

No information supplied.

Allocation concealment (selection bias)

Unclear risk

No information supplied.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Both interventions were active treatments.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Self‐reported VAS pain intensity data.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

No information supplied.

Incomplete outcome data (participant exclusion from analysis)

Unclear risk

No information supplied.

Selective reporting (reporting bias)

High risk

No data on primary outcome of study. No data on concomitant drug treatment.

Other bias

Unclear risk

No baseline comparison on pain intensity scores.

Size of study

High risk

n = 20 per group.

Tilak 2016

Study characteristics

Methods

RCT, parallel.

Participants

26 participants with phantom limb pain to 2 groups. TENS group: 11 men, 2 women, 1 dropout therefore n = 12; mirror group: 12 men, 1 female, n = 13.

Age (mean ± SD): TENS group: 36.38 ± 9.55 years; mirror group: 42.62 ± 10.69 years.

Amputations: TENS group: 3 upper and 10 lower limb amputations; mirror group: 4 upper and 9 lower limb amputations.

Onset of phantom limb pain from date of surgery: TENS group: 13 ± 1.6 days; mirror group: 13 ± 1.4 days.

Formal neuropathic pain assessment: no.

Sites of pain: upper and lower limb.

Concomitant treatment: no detail supplied.

Interventions

TENS group: no TENS frequency details supplied.

Intensity: "strong but comfortable" without visible muscle contraction.

Location: electrodes placed at site of pain on contralateral limb.

Frequency of treatment: 1 session per day for 4 days.

Duration: 20 minutes per session.

Clinic administered.

Mirror group: intact limb movements performed with mirror.

Frequency: 1 session per day for 4 days.

Duration: 20 minutes per session.

Clinic administered.

Outcomes

Pain intensity: no details supplied as to parameters of pain rating (current pain, mean pain, etc.).

0‐10 cm VAS.

Outcomes measured at baseline and 4 days later.

Study did not report adverse events.

Notes

Funding from higher education institution acknowledged.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer generated sequence.

Allocation concealment (selection bias)

Low risk

Opaque sealed envelopes.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Both interventions active treatments.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Both interventions active treatments.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

1 participant dropout adequately described.

Incomplete outcome data (participant exclusion from analysis)

Low risk

Dropout minimal. All participants analysed.

Selective reporting (reporting bias)

Low risk

All outcomes reported.

Other bias

Low risk

Adequate description and testing of baseline characteristics.

Size of study

High risk

TENS group: n = 12; mirror group: n = 13.

Vitalii 2014

Study characteristics

Methods

RCT, parallel.

Participants

25 participants with spinal cord injury. 4 participants dropped out. No details on group allocation given. TENS group: 10 men, 1 woman; sham TENS: 9 men, 1 woman.

Age (mean ± SD): TENS group: 31.72 ± 7.7 years; sham TENS group: 28.9 ± 6.1 years.

Duration of pain (mean (range)): 12.7 (0.5‐14) months for whole sample. No further data supplied.

Formal neuropathic pain assessment: LANSS > 12; mean (range) score 15.95 (13‐20).

Sites of pain: mixed.

Concomitant treatment: gabapentin started day 1 and increased in 300 mg increments daily to basic dose of 900 mg/day by day 3.

Interventions

TENS group: TENS 4 Hz, 200 ms.

Intensity: 50 mA. No description of perceived sensation.

Sham TENS group: as per active TENS but no current passed through electrodes.

Sham credibility assessment: no.

Location: electrodes proximal and distal to region with pain.

Frequency of treatment: 1 application per day for 10 days.

Duration: 30 minutes per session.

Clinic administered.

Outcomes

Pain intensity mean of morning and evening. Mean of these two scores at day 0 and day 10 used in analysis.

0‐10 cm VAS.

Outcomes measured at baseline (pretreatment) on day 0 and day 10 of the study.

Study reported adverse events and none occurred.

Notes

No conflict of interest stated.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

No details supplied.

Allocation concealment (selection bias)

Unclear risk

No details supplied.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Unclear risk for blinding of participants (TENS vs sham but no attempt to manage participant expectations of sensation and no detail on whether TENS device appeared 'live' or not). Personnel high risk as the same care provider applied active and sham treatments.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

TENS vs active sham but see comments above for blinding of participants.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

16% dropout rate. No information given with regards to group allocation.

Incomplete outcome data (participant exclusion from analysis)

Unclear risk

No obvious exclusion from analysis; however, dropout rate not fully described with respect to group allocation.

Selective reporting (reporting bias)

Low risk

All outcomes adequately reported.

Other bias

Low risk

Baseline testing reported albeit without data presented for all tests.

Size of study

High risk

TENS group: n = 11; sham TENS group: n = 10.

μs: microseconds; ACU: electroacupuncture; DN4: Douleur Neuropathique 4; DPN: diabetic peripheral neuropathy; IFT: interferential therapy; LANSS: Leeds Assessment of Neuropathic Symptoms and Signs; n: sample size; NRS: numerical rating scale; NSAID: non‐steroidal anti‐inflammatory drug; PENS: percutaneous electrical nerve stimulation; PRF: pulsed radiofrequency; RCT: randomised controlled trial; RDQ: Roland‐Morris Disability Questionnaire; SD: standard deviation; SF‐36: 36‐item Short Form; TENS: transcutaneous electrical nerve stimulation; VAS: visual analogue scale; VI: visual illusion.

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Al‐Smadi 2003

Not defined neuropathic pain.

Bahtereva 2009

Not a standard TENS unit application. Unable to contact authors.

Bloodworth 2004

Not randomised/quasi‐randomised trial.

Bourke 1994

Not randomised/quasi‐randomised trial.

Casale 1985

Outcome measure not pain intensity.

Cheing 2005

Pain intensity scoring in response to stimulus evoked pain. Stimulus applied by researcher.

Chitsaz 2009

Outcome measure a VAS composite of pain and sensory complaints.

Connolly 2013

All participants received perceptual TENS.

Finsen 1988

Outcome measure not Pain intensity.

Forst 2004

Outcome measure a VAS composite of pain and sensory symptoms.

Franca 2013

Not defined neuropathic pain.

Gossrau 2011

TENS applied below perceptual level.

Heidenreich 1988

Not clearly randomised trial.

Ing 2015

Not a standard TENS device.

Katz 1991

Outcome measured < 24 hours post‐treatment.

Kumar 1997

Outcome measure not pain intensity. VAS was a composite of pain intensity, paraesthesia and sleep disturbance. Outcome measure not self‐reported.

Kumar 1998

Outcome measure not pain intensity. VAS was a composite of pain intensity, paraesthesia and sleep disturbance. Outcome measure not self‐reported.

Lehmkuhl 1978

Outcome measured < 24 hours post‐treatment.

Marques 2014

Not defined neuropathic pain.

Mysliwiec 2012

Outcome measure not pain intensity. Not defined neuropathic pain participants.

Norrbrink 2009

All participants received TENS.

Oosterhof 2008

No pain intensity follow‐up data. Unable to extract potential neuropathic participant data.

Pourmomeny 2009

Outcome measure not pain intensity. VAS was a composite measure of pain and non‐pain symptoms.

Reichstein 2005

Not all participants had pain as a symptom. Outcome measure encompassed non‐pain symptoms.

Sherry 2001

Not defined neuropathic pain.

Stepanovic 2015

Not defined neuropathic pain.

Thorsteinsson 1977

Outcome measured < 24 hours post‐treatment.

Warke 2004

Not defined neuropathic pain condition in study.

Warke 2006

Not defined neuropathic pain condition in study.

Wong 2016

Not randomised/quasi‐randomised trial.

Yameen 2011

All participants received TENS.

TENS: transcutaneous electrical nerve stimulation; VAS: visual analogue scale.

Characteristics of studies awaiting classification [ordered by study ID]

ICTRPNCT02496351

Methods

Not available.

Participants

Not available.

Interventions

Not available.

Outcomes

Not available.

Notes

Unable to contact study authors.

Samier 2006

Methods

Participants

Interventions

Outcomes

Notes

Attempted contact with author. No reply.

Wang 2009

Methods

RCT, parallel

Participants

Randomised n = 139 with 'senile radical sciatica' randomised to electroacupuncture (n = 70) or TENS (n = 69) treatments. Awaiting translation. No further details.

Interventions

Awaiting translation.

Outcomes

Notes

n: number of participants; TENS: transcutaneous electrical nerve stimulation.

Data and analyses

Open in table viewer
Comparison 1. TENS versus sham TENS

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1.1 Pain intensity Show forest plot

5

207

Mean Difference (IV, Random, 95% CI)

‐1.58 [‐2.08, ‐1.09]

Analysis 1.1

Comparison 1: TENS versus sham TENS, Outcome 1: Pain intensity

Comparison 1: TENS versus sham TENS, Outcome 1: Pain intensity

1.2 Pain intensity sensitivity analysis (Celik 2013 removed) Show forest plot

4

174

Mean Difference (IV, Random, 95% CI)

‐1.44 [‐1.87, ‐1.02]

Analysis 1.2

Comparison 1: TENS versus sham TENS, Outcome 2: Pain intensity sensitivity analysis (Celik 2013 removed)

Comparison 1: TENS versus sham TENS, Outcome 2: Pain intensity sensitivity analysis (Celik 2013 removed)

Study flow diagram.

Figuras y tablas -
Figure 1

Study flow diagram.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Figuras y tablas -
Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Figuras y tablas -
Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Forest plot of comparison: 1 TENS versus sham TENS, outcome: 1.1 Pain intensity.

Figuras y tablas -
Figure 4

Forest plot of comparison: 1 TENS versus sham TENS, outcome: 1.1 Pain intensity.

Forest plot of comparison: 1 TENS versus sham TENS, outcome: 1.2 Pain intensity sensitivity analysis (Celik 2013 removed).

Figuras y tablas -
Figure 5

Forest plot of comparison: 1 TENS versus sham TENS, outcome: 1.2 Pain intensity sensitivity analysis (Celik 2013 removed).

Comparison 1: TENS versus sham TENS, Outcome 1: Pain intensity

Figuras y tablas -
Analysis 1.1

Comparison 1: TENS versus sham TENS, Outcome 1: Pain intensity

Comparison 1: TENS versus sham TENS, Outcome 2: Pain intensity sensitivity analysis (Celik 2013 removed)

Figuras y tablas -
Analysis 1.2

Comparison 1: TENS versus sham TENS, Outcome 2: Pain intensity sensitivity analysis (Celik 2013 removed)

Summary of findings 1. TENS versus sham TENS

TENS versus sham TENS for neuropathic pain in adults

Patient or population: adults with neuropathic pain

Settings: secondary care

Intervention/comparison: TENS vs sham TENS

Outcome: Pain intensity (VAS)

Outcomes

Effect estimate

(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Post‐intervention pain intensity

(VAS 0‐10)

Favoured TENS. Mean difference

‐1.58 (95% CI ‐2.08 to ‐1.09)

207 (5)

⊕⊝⊝⊝ Very lowa

Downgraded 3 levels due to multiple

sources of potential bias, small number

and size of studies.

Health related quality of life

No data

Participant global impression of change

No data

Analgesic medication use

Not estimable

Incidence/nature of adverse events

Not estimable

CI: confidence interval; TENS: transcutaneous electrical nerve stimulation; VAS: visual analogue scale.

GRADE Working Group grades of evidence
High quality: we are very confident that the true effect lies close to that of the estimate of the effect.
Moderate quality: we are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of effect, but there is a possibility that it is substantially different.
Low quality: our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect.
Very low quality: we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect.

aDowngraded twice for limitations of studies and once for imprecision.

Figuras y tablas -
Summary of findings 1. TENS versus sham TENS
Table 1. Details of participants and TENS parameters in included studies

Study, comparison (admitted sample size)

Group baseline pain intensity VAS/NRS

Neuropathic condition

Reported mean duration

Diagnostic criteria

Hz and pulse width

Electrode location

Intensity

Duration, frequency and site of administration

Barbarisi 2010

TENS vs sham TENS (30)

P300 + TENS: 4 ± 0.93

P600 + TENS: 3.8 0.95

P300 + sham TENS: 4.1 ± 1.19

P600 + sham TENS: 3.2 ± 0.81

Postherpetic neuralgia

15.25 ± 8.7 months

No formal or clinical neuropathic diagnostic criteria

100 Hz (later described in text as 50 Hz)

125 µs

"Around site of pain"

"Clear non‐painful paraesthesia".

Titrated to maintain strength of perception

30 minutes daily for 4 weeks

Clinic administration

Bi 2015

TENS vs sham TENS (52)

TENS: 5.17 ± 2.34 Sham TENS: 5.56 ± 2.07

Spinal cord injury

6.9 ± 3.6 months (since spinal cord injury)

No formal or clinical neuropathic diagnostic criteria

2 Hz

200 ms

Placed "on region with pain"

50 mA. No description of perceived sensation

20 minutes 3 × weekly for 12 weeks

Clinic administration

Buchmuller 2012

TENS vs sham TENS (122)

TENS: 6.15 ± 2.24 Sham TENS: 5.91 ± 2.12

Lumbar radicular pain (subgroup data supplied by authors)

Not reported

Clinical assessment

Mixed: 80‐100 Hz alternated with 2 Hz

200 ms

Placed on low back and radicular region of pain

Low intensity paraesthesia alternated with high intensity (muscle twitches)

1 hour. 4 × daily for 3 months

Self‐administered at home

Casale 2013

TENS vs laser? (20)

TENS: 6 ± 0.8 Laser?: 6.6 ± 1.1

Carpal tunnel syndrome

Not reported

Nerve conduction study

100 Hz

80 ms

Over carpal ligament and median nerve

"Below muscle contraction"

30 minutes 5 × weekly for 3 weeks

Clinic administration

Celik 2013

TENS vs sham TENS (33)

TENS: 5.79 ± 2.17

Sham TENS: 5.64 ± 1.81

Spinal cord injury

19.1 months

LANSSa > 12

4 Hz

200 µs

Placed "on region with pain"

50 mA. No description of perceived sensation

30 minutes 1 × daily for

10 days

Clinic administration

Gerson 1977

TENS vs drug

treatment (29)

TENS: 27.0

Drug: 59.0

(0‐100)

Postherpetic neuralgia

No details

No formal or clinical neuropathic diagnostic criteria

No details

"Placed on affected dermatome"

No detail

15 minutes 1 × weekly for 4 weeks then 1 × fortnightly for 3 weeks

Ghoname 1999

TENS vs PENS (64)

TENS: 7.0 ± 1.9

PENS: 7.2 ± 1.8

Sham PENS: 6.6 ± 1.9

Lumbar radicular pain

21 ± 9 months

Clinical assessment.

Radiological assessment of nerve root compression

4 Hz

100 ms

Placed on posterior lower limb

"Highest tolerable sensation" without muscle twitch

30 minutes 3 × weekly for 3 weeks

Clinic administration

Koca 2014

TENS vs IFT (75)

TENS: 8.06 ± 0.55

IFT: 8.25 ± 0.4

Splint: 8.31 ± 0.6

Carpal tunnel syndrome

13.3 ± 6.3 months

Nerve conduction study

100 Hz

80 ms

Placed on "palmar aspect of hand/wrist"

No details

20 minutes 5 × weekly for 3 weeks

Clinic administration

Nabi 2015

TENS vs PRF sympathectomy (65)

TENS: 6.10

PRF sympathectomy: 6.46

(NRS)

Peripheral diabetic neuropathy

12.9 ± 3 years (since diabetes

onset)

Clinical diagnosis

80 Hz

200 µs

"Around shin and ankle"

"two to three times sensory threshold"

20 minutes 10 treatment sessions on alternate days

Clinic administration

Őzkul 2015

TENS vs visual illusion (26)

TENS: 5.33 ± 1.20

Visual

illusion:

5.33 ± 1.37

Spinal cord injury

12.4 ± 17.8 months

≥ 4 on DN4

80 Hz

180 µs

Bilaterally around spine above level of injury

"perceptible but comfortable"

30 minutes 5 × weekly for 2 weeks

Clinic administration

Prabhakar 2011

TENS vs cervical spine mobilisation (75)

Not stated

Cervical radicular pain (75)

No details

No formal or clinical neuropathic diagnostic criteria

100 Hz

50 µs

Placed at 'cervical spinal segment and distal dermatome

No details

30 minutes 10 sessions on alternate days over 3 weeks

Clinic administration

Rutgers 1988

TENS vs acupuncture (26)

Not stated

Postherpetic neuralgia

"3 months to 9 years"

No formal or clinical neuropathic diagnostic criteria

100 Hz

200 µs

"Either side of painful area"

"Fairly strong sensation"

3 × 30 minute clinic sessions week 1. Then home use for 5 weeks. No detail on home use frequency/duration

Serry 2015

TENS vs exercise

(60)

Not stated

Peripheral diabetic neuropathy

12.2 ± 2.3 years

(since onset of neuropathy

)

No formal or clinical neuropathic diagnostic criteria

15 Hz

250 µs

Lower leg/ankle

"Strong rhythmic muscle contractions"

30 minutes 3 × weekly for 8 weeks

Clinic administration

Tilak 2016

TENS vs mirror therapy

TENS: 5.00 ± 1.63

Mirror: 5.46 ± 1.67

Phantom limb pain

13 ± 1.5 days (since onset of phantom limb pain)

No formal or clinical neuropathic diagnostic criteria

No details

Site of pain contralateral limb

"Strong but comfortable"

20 minutes 1 × daily for 4 days

Clinic administration

Vitalii 2014

TENS vs sham TENS (25)

TENS: 8.09 ± 0.97

Sham TENS: 8.05 ± 1.05

Spinal cord injury

12.7 months

LANSS > 12

4 Hz

200 ms

Proximal and distal to pain region

50 mA. No description of perceived sensation

30 minutes 1 × daily for 10 days

Clinic administration

DN4: Douleur Neuropathique 4; IFT: interferential therapy; LANSS: Leeds Assessment of Neuropathic Symptoms and Signs pain scale; NRS: numerical rating scale; P300: pregabalin 300 mg; P600: pregabalin 600 mg; PENS: percutaneous electrical nerve stimulation; PRF: pulsed radiofrequency; TENS: transcutaneous electrical nerve stimulation; VAS: visual analogue scale.

Figuras y tablas -
Table 1. Details of participants and TENS parameters in included studies
Comparison 1. TENS versus sham TENS

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1.1 Pain intensity Show forest plot

5

207

Mean Difference (IV, Random, 95% CI)

‐1.58 [‐2.08, ‐1.09]

1.2 Pain intensity sensitivity analysis (Celik 2013 removed) Show forest plot

4

174

Mean Difference (IV, Random, 95% CI)

‐1.44 [‐1.87, ‐1.02]

Figuras y tablas -
Comparison 1. TENS versus sham TENS