Transcutaneous electrostimulation for osteoarthritis of the knee

Anne WS Rutjes; Eveline Nüesch; Rebekka Sterchi; Leonid Kalichman; Erik Hendriks; Manathip Osiri; Lucie Brosseau; Stephan Reichenbach; Peter Jüni

doi:10.1002/14651858.CD002823.pub2

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Figure 1

Flow chart

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Figure 2

Methodological characteristics and source of funding of included trials. (+) indicates low risk of bias, (?) unclear and (‐) a high risk of bias on a specific item.

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Figure 3

Forest plot of 16 trials comparing the effects of any type of transcutaneous electrostimulation and control (sham or no intervention) on knee pain. Values on x‐axis denote standardised mean differences. The plot is stratified according to type of electrostimulation. Law 2004 reported on knee level, we inflated the standard error with sqrt(number knees)/sqrt(number patients) to correct for clustering of knees within patients. Adedoyin 2005 and Cheing 2002 contributed with two comparisons each. In Adedoyin 2005, the standard error was inflated and the number of patients in the control group was halved to avoid duplicate counting of patients when including 2 both comparisons in the overall meta‐analysis. Data relating to the 3, 2, 3 and 4 active intervention arms in Cheing 2003, Grimmer 1992, Law 2004 and Defrin 2005, respectively, were pooled.

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Figure 4

Funnel plot for effects on knee pain.
Numbers on x‐axis refer to standardised mean differences (SMDs), on y‐axis to standard errors of SMDs.

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Figure 5

Forest plot of 8 trials comparing patients withdrawn or dropped out because of adverse events between any transcutaneous electrostimulation and control (sham or no intervention). Values on x‐axis denote risk ratios. Risk ratios could not be estimated in 5 trials, because no drop‐out occurred in either group. The plot is stratified according to type of electrostimulation. Data relating to the 3 and 2 active intervention arms in Cheing 2003 and Grimmer 1992, respectively, were pooled.

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Figure 6

Forest plot of 9 trials comparing the effects of any type of transcutaneous electrostimulation and control (sham or no intervention) on function. Values on x‐axis denote standardised mean differences. The plot is stratified according to type of electrostimulation. In Adedoyin 2005, the standard error was inflated and the number of patients in the control group was halved to avoid duplicate counting of patients when including both comparisons in the overall meta‐analysis.

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Figure 7

Funnel plot for effects on functioning of the knee.
Numbers on x‐axis refer to standardised mean differences (SMDs), on y‐axis to standard errors of SMDs.

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Figure 8

Forest plot of 3 trials comparing patients experiencing any adverse event between any transcutaneous electrostimulation and control (sham or no intervention). Values on x‐axis denote risks ratios. The risk ratio in one TENS trial could not be estimated because no adverse event occurred in either group. The plot is stratified according to type of electrostimulation.

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Figure 9

Forest plot of 4 trials comparing patients experiencing any serious adverse event between any transcutaneous electrostimulation and control (sham or no intervention). Values on x‐axis denote risk ratios. Risk ratios could not be estimated in 3 trials, because no serious adverse event occurred in either group. The plot is stratified according to type of electrostimulation. Data relating to the 3 active intervention arms in Cheing 2003 were pooled.

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Analysis 1.1

Comparison 1 Any type of transcutaneous electrostimulation versus control, Outcome 1 Pain.

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Analysis 1.2

Comparison 1 Any type of transcutaneous electrostimulation versus control, Outcome 2 Number of patients withdrawn or dropped out because of adverse events.

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Analysis 1.3

Comparison 1 Any type of transcutaneous electrostimulation versus control, Outcome 3 Function.

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Analysis 1.4

Comparison 1 Any type of transcutaneous electrostimulation versus control, Outcome 4 Number of patients experiencing any adverse event.

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Analysis 1.5

Comparison 1 Any type of transcutaneous electrostimulation versus control, Outcome 5 Number of patients experiencing any serious adverse event.

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Any type of transcutaneous electrostimulation compared with sham or no intervention for osteoarthritis of the knee
Patient or population: patients with osteoarthritis Settings: physical therapy practice of outpatient clinic Intervention: any type of transcutaneous applied electrostimulation Comparison: sham or no specific intervention
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk*	Corresponding risk
	Sham or no specific intervention	Any type of transcutaneous electrostimulation
Pain Various pain scales Median follow‐up: 4 weeks	‐1.8 cm change on 10 cm VAS¹ 29% improvement	‐2.0 cm change (Δ ‐0.2 cm, ‐1.2 to 0.8 cm)² 33% improvement (Δ +4%, ‐13% to +20%)³	SMD ‐0.07 (‐0.46 to 0.32)	726 (16 studies)	+OOO very low⁴	Little evidence of beneficial effect (NNT: not statistically significant) The estimated pain in the intervention group of large trials was derived from meta‐regression using the standard error as independent variable
Function Various validated function scales Median follow‐up: 4 weeks	‐1.2 units on WOMAC (range 0 to 10)¹ 21% improvement	‐2.3 units on WOMAC (Δ ‐1.1, ‐1.6 to ‐0.6)⁵ 41% improvement (Δ +20%, +11% to +29%)⁶	SMD ‐0.34 (‐0.54 to ‐0.14)	407 (9 studies)	+OOO very low⁷	NNT: 10 (95% CI 7 to 22)⁸
Number of patients experiencing any adverse event Median follow‐up: 4 weeks	150 per 1000 patient‐years¹	153 per 1000 patient‐years (80 to 296)	RR 1.02 (0.53 to 1.97)	175 (3 studies)	++OO low⁹	No evidence of harmful effect (NNH: not statistically significant)
Number of patients withdrawn or dropped out because of adverse events Median follow‐up: 4 weeks	17 per 1000 patient‐years¹	16 per 1000 patient‐years (3 to 102)	RR 0.97 (0.16 to 6.00)	363 (8 studies)	+++O moderate¹⁰	No evidence of harmful effect (NNH: not statistically significant)
Number of patients experiencing any serious adverse event Median follow ‐up: 4 weeks	4 per 1000 patient‐years¹	1 per 1000 patient‐years (0 to 29)	RR 0.33 (0.02 to 7.32)	195 (4 studies)	++OO low¹¹	No evidence of harmful effect (NNH: not statistically significant)
The basis for the assumed risk* in the safety outcomes (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; GRADE: GRADE Working Group grades of evidence (see explanations); NNT: number needed to treat; NNH: number needed to harm; RR: risk ratio; SMD: standardised mean difference
GRADE Working Group grades of evidence High quality (++++): Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality (+++O): Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality (++OO): Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality (+OOO): We are very uncertain about the estimate. ¹ Median reduction as observed across control groups in large osteoarthritis trials (Nuesch 2009). ² Standardised mean differences (SMDs) were back‐transformed onto a 10 cm visual analogue scale (VAS) on the basis of a typical pooled SD of 2.5 cm in trials that assessed pain using a VAS, and expressed as change based on an assumed standardised reduction of 0.72 standard deviation units in the control group. ³ The median observed pain score at baseline across control groups in large osteoarthritis trials was 6.1 cm on a 10 cm VAS (Nuesch 2009). ⁴ Downgraded (3 levels) because the effect was estimated from a meta‐regression model using the standard error as independent variable and because included trials were generally of low quality and small sample size: only 2 out of 16 trials used adequate concealment of allocation, only 3 performed analyses according to the intention‐to‐treat principle, and the presence of large between trial heterogeneity. ⁵ Standardised mean differences (SMDs) were back‐transformed onto a 0 to 10 standardised WOMAC function score on the basis of a typical pooled SD of 2.1 in trials that assessed function on WOMAC function scale and expressed as change based on an assumed standardised reduction of 0.58 standard deviation units in the control group. ⁶ The median observed standardised WOMAC function score at baseline across control groups in large osteoarthritis trials was 5.6 units (Nuesch 2009). ⁷ Downgraded (3 levels) because included trials were generally of low quality and small sample size: 1 out of 9 studies used adequate concealment of allocation methods, only 2 performed analyses according to the intention‐to‐treat principle, presence of moderate between trial heterogeneity, 9 out of 18 studies reported this outcome, likely leading to selective outcome reporting bias. ⁸ Absolute response risks for function in the control groups were assumed 26% (see Methods section). ⁹ Downgraded (2 levels) because the confidence interval crosses no difference in the pooled estimate, 1 out of 3 studies included all patients in this analysis, 3 out of 18 studies reported this outcome, likely leading to selective outcome reporting bias. ¹⁰ Downgraded (1 level) because the confidence interval of the pooled estimate is wide and crossed no difference, 8 out of 18 studies reported this outcome, possibly leading to selective outcome reporting bias. ¹¹ Downgraded (2 levels) because 4 out of 18 studies reported this outcome, possibly leading to selective outcome reporting bias, the confidence interval of the pooled estimate is wide and crossed no difference.

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Table 1. Results of stratified analyses of pain outcomes

Variable	N of trials	N of patients (experimental)	N of patients (control)	Pain intensity	Heterogeneity	P for interaction
	n	n	n	SMD (95% CI)	I² (%)
All trials	16	440	286	‐0.86 (‐1.23 to ‐0.49)	80%
Allocation concealment						0.47
Adequate	2	79	39	‐0.52 (‐0.91 to ‐0.13)	0%
Inadequate or unclear	14	361	247	‐1.03 (‐1.49 to ‐0.57)	84%
Type of control intervention*						0.12
Sham intervention	12	354	216	‐1.13 (‐1.59 to ‐0.67)	82%
No control intervention	5	86	70	‐0.31 (‐0.80 to 0.19)	58%
Blinding of patients						0.37
Adequate	11	309	205	‐1.05 (‐1.52 to ‐0.59)	82%
Inadequate or unclear	6	131	79	‐0.63 (‐1.31 to 0.05)	81%
Use of analgesic cointerventions						0.36
Similar between groups	4	124	83	‐0.57 (‐1.16 to 0.02)	74%
Not similar or unclear	12	316	23	‐1.10 (‐1.60 to ‐0.59)	84%
Intention‐to‐treat analysis						0.73
Yes	3	83	63	‐0.76 (‐1.43 to ‐0.09)	72%
No or unclear	13	357	223	‐1.00 (‐1.48 to ‐0.53)	84%
Type of ES**						0.94
High frequency TENS	8	177	139	‐0.82 (‐1.51 to ‐0.12)	86%
Burst TENS	2	39	38	‐0.85 (‐1.32 to ‐0.38)	0%
Modulation TENS	1	13	3	‐1.41 (‐2.92 to 0.10)	N/A
Low frequency TENS	3	46	40	‐0.82 (‐1.29 to ‐0.34)	0%
Interferential current stimulation	4	88	44	‐1.20 (‐1.99 to ‐0.42)	71%
Pulsed ES	2	77	52	‐0.41 (‐0.77 to ‐0.05)	0%
Duration of ES per session†						0.69‡
≤ 20 minutes	8	166	112	‐0.95 (‐1.55 to ‐0.35)	78%
30 to 40 minutes	6	156	99	‐1.45 (‐2.28 to ‐0.62)	85%
≥ 60 minutes	4	118	91	‐0.47 (‐0.96 to 0.02)	58%
Number of sessions per week						0.90‡
≤ 3	6	163	91	‐0.81 (‐1.48 to ‐0.14)	82%
4 to 6	7	182	125	‐1.33 (‐2.11 to ‐0.54)	88%
≥ 7	3	96	70	‐0.51 (‐0.83 to ‐0.19)	0%
Duration of ES per week***						0.74‡
≤1 hour	5	123	71	‐0.85 (‐1.72 to 0.01)	86%
> 1 to 5 hours	8	180	122	‐1.42 (‐2.11 to ‐0.74)	81%
> 5 hours	5	137	109	‐0.53 (‐0.96 to ‐0.11)	55%
Duration of treatment period						0.14
< 4 weeks	7	190	114	‐1.39 (‐2.13 to ‐0.66)	86%
≥ 4 weeks	9	250	172	‐0.64 (‐1.06 to ‐0.22)	75%
ES: electrostimulation; In Cheing 2002, two independent comparisons contributed in the two different strata. *Adedoyin 2005, Grimmer 1992 and Law 2004 contributed to two, two and three different strata: high‐frequency TENS and interferential current stimulation, high‐frequency TENS and burst, and high‐, low‐frequency and modulation TENS, respectively. † = Cheing 2003 contributed to all three different strata, with the same 8 control patients displayed in each stratum. ‡ = P values from test for trend.

Table 1. Results of stratified analyses of pain outcomes

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Table 2. Results of stratified analyses of function

Variable	N of trials	N of patients (experimental)	N of patients (control)	Function	Heterogeneity	P for interaction
				SMD (95% CI)	I² (%)
All trials	9	226	181	‐0.34 (‐0.54 to ‐0.14)	0%
Allocation concealment						0.88
Adequate	1	39	19	‐0.29 (‐0.85 to 0.26)	N/A
Inadequate or unclear	8	187	162	‐0.34 (‐0.56 to ‐0.12)	5%
Type of control intervention						0.14
Sham intervention	5	151	120	‐0.46 (‐0.70 to ‐0.21)	0%
No control intervention	4	75	61	‐0.10 (‐0.45 to 0.24)	0%
Blinding of patients						0.14
Adequate	5	151	120	‐0.46 (‐0.70 to ‐0.21)	0%
Inadequate or unclear	4	75	61	‐0.10 (‐0.45 to 0.24)	0%
Use of analgesic cointerventions						0.95
Similar between groups	2	69	48	‐0.33 (‐0.70 to 0.05)	0%
Not similar or unclear	7	157	133	‐0.34 (‐0.60 to ‐0.08)	15%
Intention‐to‐treat analysis						0.76
Yes	2	40	42	‐0.28 (‐0.71 to 0.16)	0%
No or unclear	7	186	139	‐0.35 (‐0.58 to ‐0.12)	5%
Type of ES**						0.32
High frequency TENS	4	84	70	‐0.18 (‐0.50 to 0.14)	0%
Burst TENS	0
Modulation TENS	0
Low frequency TENS	1	25	25	‐0.88 (‐1.46 to ‐0.30)	N/A
Interferential current stimulation	3	40	34	‐0.27 (‐0.75 to 0.20)	0%
Pulsed ES	2	77	52	‐0.36 (‐0.72 to ‐0.00)	0%
Duration of ES per session						0.80‡
≤ 20 minutes	5	100	86	‐0.29 (‐0.69 to 0.11)	44%
30 to 40 minutes	2	49	43	‐0.37 (‐0.79 to 0.04)	0%
≥ 60 minutes	2	77	52	‐0.36 (‐0.72 to ‐0.00)	0%
Number of sessions per week						0.32‡
≤ 3	4	75	61	‐0.10 (‐0.45 to 0.24)	0%
4 to 6	3	74	68	‐0.54 (‐0.88 to ‐0.20)	2%
≥ 7	2	77	52	‐0.36 (‐0.72 to ‐0.00)	0%
Duration of ES per week						0.32‡
≤ 1 hour	4	75	61	‐0.10 (‐0.45 to 0.24)	0%
> 1 to 5 hours	3	74	68	‐0.54 (‐0.88 to ‐0.20)	2%
> 5 hours	2	77	52	‐0.36 (‐0.72 to ‐0.00)	0%
Duration of treatment period						0.18
< 4 weeks	3	74	68	‐0.54 (‐0.88 to ‐0.20)	2%
≥ 4 weeks	6	152	113	‐0.23 (‐0.47 to 0.02)	0%
ES: electrostimulation; **Adedoyin 2005 contributed to two different strata: high‐frequency TENS and interferential current stimulation; ‡ = P values from test for trend.

Table 2. Results of stratified analyses of function

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Comparison 1. Any type of transcutaneous electrostimulation versus control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain Show forest plot	16	726	Std. Mean Difference (Random, 95% CI)	‐0.86 [‐1.23, ‐0.49]

1.1 TENS	11	465	Std. Mean Difference (Random, 95% CI)	‐0.85 [‐1.36, ‐0.34]
1.2 Interferential current stimulation	4	132	Std. Mean Difference (Random, 95% CI)	‐1.20 [‐1.99, ‐0.42]
1.3 Pulsed electrostimulation	2	129	Std. Mean Difference (Random, 95% CI)	‐0.41 [‐0.77, ‐0.05]
2 Number of patients withdrawn or dropped out because of adverse events Show forest plot	8	363	Risk Ratio (IV, Random, 95% CI)	0.97 [0.16, 6.00]

2.1 TENS	6	255	Risk Ratio (IV, Random, 95% CI)	0.60 [0.03, 14.15]
2.2 Interferential current stimulation	1	30	Risk Ratio (IV, Random, 95% CI)	0.0 [0.0, 0.0]
2.3 Pulsed electrostimulation	1	78	Risk Ratio (IV, Random, 95% CI)	1.80 [0.17, 19.10]
3 Function Show forest plot	9	407	Std. Mean Difference (Random, 95% CI)	‐0.34 [‐0.54, ‐0.14]

3.1 TENS	5	204	Std. Mean Difference (Random, 95% CI)	‐0.33 [‐0.69, 0.03]
3.2 Interferential current stimulation	3	74	Std. Mean Difference (Random, 95% CI)	‐0.27 [‐0.75, 0.20]
3.3 Pulsed electrostimulation	2	129	Std. Mean Difference (Random, 95% CI)	‐0.36 [‐0.72, ‐0.00]
4 Number of patients experiencing any adverse event Show forest plot	3	175	Risk Ratio (IV, Random, 95% CI)	1.02 [0.53, 1.97]

4.1 TENS	1	39	Risk Ratio (IV, Random, 95% CI)	0.0 [0.0, 0.0]
4.2 Pulsed electrostimulation	2	136	Risk Ratio (IV, Random, 95% CI)	1.02 [0.53, 1.97]
5 Number of patients experiencing any serious adverse event Show forest plot	4	195	Risk Ratio (IV, Random, 95% CI)	0.33 [0.02, 7.32]

5.1 TENS	2	59	Risk Ratio (IV, Random, 95% CI)	0.33 [0.02, 7.32]
5.2 Pulsed electrostimulation	2	136	Risk Ratio (IV, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 1. Any type of transcutaneous electrostimulation versus control

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