Rehabilitation following surgery for lumbar spinal stenosis

Alison H McGregor; Katrin Probyn; Suzie Cro; Caroline J Doré; A Kim Burton; Federico Balagué; Tamar Pincus; Jeremy Fairbank

doi:10.1002/14651858.CD009644.pub2

Cochrane Database of Systematic Reviews

Rehabilitación posquirúrgica para la estenosis lumbar

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DOI:

https://doi.org/10.1002/14651858.CD009644.pub2 Copiar DOI

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Cochrane Database of Systematic Reviews

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09 diciembre 2013see what's new

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Intervention

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Review

Grupo Editorial Cochrane:

Grupo Cochrane de Espalda y cuello

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Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Autores

Alison H McGregor

Correspondencia a: Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK

[email protected]
Katrin Probyn

Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK
Suzie Cro

Medical Research Council Clinical Trials Unit, London, UK
Caroline J Doré

Medical Research Council Clinical Trials Unit, London, UK
A Kim Burton

Ergonomics and Clinical Biomechanics, Spine Research Unit, University of Huddersfield, Huddersfield, UK
Federico Balagué

Cantonal Hospital of Fribourg, Fribourg, Switzerland
Tamar Pincus

Department of Psychology, Royal Holloway University of London, Egham, UK
Jeremy Fairbank

Department of Orthopaedic Surgery, Nuffield Orthopaedic Centre, Oxford, UK

Contributions of authors

All authors have contributed to the development of this review. AMcG and KP screened the search results and selected studies. AKB, FB, TP and JF were involved in the final decision making. AMcG, KP and SC extracted the data (AMcG was not involved in data extraction from the trial McGregor 2010, for which she served as first author). Risk of bias assessment was completed by KP and SC. GRADE assessment and assessment of clinical relevance were completed by KP and SC. Analysis was done by KP and SC, and CJD was also involved in the process. AMcG, KP and SC were the main authors of the text. All review authors contributed to the review writing process.

Sources of support

Internal sources

International Society for the Study of the Lumbar Spine, UK.

This work is being supported by prize money from the International Society for the Study of the Lumbar Spine held in a trust account by Alison McGregor

External sources

No external sources of support given, Not specified.

Declarations of interest

None known.

Acknowledgements

We thank Teresa Marin, Rachel Couban and Allison Kelly from the Cochrane Back Review Group for their help.

Version history

Published

Title

Stage

Authors

Version

2013 Dec 09

Rehabilitation following surgery for lumbar spinal stenosis

Review

Alison H McGregor, Katrin Probyn, Suzie Cro, Caroline J Doré, A Kim Burton, Federico Balagué, Tamar Pincus, Jeremy Fairbank

https://doi.org/10.1002/14651858.CD009644.pub2

2012 Feb 15

Rehabilitation following surgery for lumbar spinal stenosis

Protocol

Alison H McGregor, Katrin Probyn, Caroline J Doré, A Kim Burton, Suzie Cro, Alexander Crispin, Federico Balagué, Stephen Morris, Tamar Pincus, Jeremy Fairbank

https://doi.org/10.1002/14651858.CD009644

Differences between protocol and review

In the published study protocol (Protocol), we originally planned for the primary outcome to be 'change in functional status'; however,

We were unable to obtain reported changes in functional status plus standard deviations for all three studies included in this review.

Because data from the included trials were lacking, we decided to analyse 'functional status' as the primary outcome. This analysis does not take into account where participants were at the start of the study and immediately post surgery; therefore, a lower postrehabilitation value could theoretically be caused by a lower value at baseline; however, exploration of baseline data revealed no substantial differences between groups at baseline (Table 2).

We did consider imputing the change score standard deviation from available study data, but because follow‐up times of the short‐term outcomes varied (McGregor 2010—three months, Mannion 2007—five months and Aalto 2011—six months), we concluded that using a method that involves an imputed correlation coefficient would be inappropriate.

Reporting of adverse events was not specified as an outcome in our Protocol; however, it has been documented as an outcome in summary of findings Table for the main comparison and summary of findings Table 2 in this review.

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

Humans;

PICO

Population

Intervention

Comparison

Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Figure 1

Study flow diagram.

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Figure 2

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

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Figure 3

Forest plot of comparison: 1 Short term, outcome: 1.1 Functional status short term on log‐scale.

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Figure 4

Forest plot of comparison: 1 Short term, outcome: 1.3 Low back pain short term on log‐scale.

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Figure 5

Forest plot of comparison: 1 Short term, outcome: 1.2 Leg pain short term on log‐scale.

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Figure 6

Forest plot of comparison: 1 Short term, outcome: 1.4 General health.

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Figure 7

Forest plot of comparison: 2 Long term, outcome: 2.1 Functional status long term on log‐scale.

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Figure 8

Forest plot of comparison: 2 Long term, outcome: 2.3 Low back pain long term on log‐scale.

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Figure 9

Forest plot of comparison: 2 Long term, outcome: 2.2 Leg pain long term on log‐scale.

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Figure 10

Forest plot of comparison: 2 Long term, outcome: 2.4 General health long term.

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Analysis 1.1

Comparison 1 Short term, Outcome 1 Functional status short term (log‐scale).

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Analysis 1.2

Comparison 1 Short term, Outcome 2 Leg pain short term (log‐scale).

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Analysis 1.3

Comparison 1 Short term, Outcome 3 Low back pain short term (log‐scale).

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Analysis 1.4

Comparison 1 Short term, Outcome 4 General health.

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Analysis 2.1

Comparison 2 Long term, Outcome 1 Functional status long term (log‐scale).

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Analysis 2.2

Comparison 2 Long term, Outcome 2 Leg pain long term (log‐scale).

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Analysis 2.3

Comparison 2 Long term, Outcome 3 Low back pain long term (log‐scale).

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Analysis 2.4

Comparison 2 Long term, Outcome 4 General health long term.

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Summary of findings for the main comparison. Rehabilitation following surgery for lumbar spinal stenosis—short‐term outcomes

Rehabilitation following surgery for lumbar spinal stenosis—short‐term outcomes
Patient or population: participants with lumbar spinal stenosis Settings: hospital Intervention: rehabilitation after surgery
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No. of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Control	Rehabilitation after surgery
Functional status, short term Oswestry Disability Index (ODI 0 to 100%) or Roland Morris (0 to 24) Follow‐up: three to six months	Mean functional status short term ranged across control groups from 1.98 to 3.32 on log‐scale	Mean functional status short term in the intervention groups was 0.22 standard deviations lower (0.44 lower to 0 higher)		340 (three studies)	⊕⊕⊕⊝ Moderate¹	SMD on the log‐scale corresponds to 20% improvement (0% to 36% improvement) in the rehabilitation group. This difference is clinically relevant²
Leg pain, short term Visual analog scale (VAS 0 to 100) Follow‐up: three to six months	Mean leg pain short term ranged across control groups from 2.88 to 3.42 on log‐scale	Mean leg pain short term in the intervention groups was 0.17 lower (0.52 lower to 0.19 higher)		340 (three studies)	⊕⊕⊝⊝ Low^3,4	MD on the log‐scale corresponds to 16% improvement (21% worsening to 41% improvement). This difference is not statistically or clinically relevant⁵
Low back pain, short term Visual analogue scale (VAS 0 to 100) Follow‐up: three to six months	Mean low back pain short term ranged across control groups from 2.50 to 3.51 on log‐scale	Mean low back pain short term in the intervention groups was 0.18 lower (0.35 to 0.02 lower)		340 (three studies)	⊕⊕⊕⊝ Moderate⁶	MD on the log‐scale corresponds to 16% improvement (2% to 30% improvement) in low back pain. This difference is not clinically relevant⁵
General health, short term Visual analogue scale (VAS 100 to 0) Follow‐up: three to five months	Mean general health short term ranged across control groups from 66 to 74	Mean general health short term in the intervention groups was 1.3 higher (4.45 lower to 7.06 higher)		238 (two studies)	⊕⊕⊝⊝ Low^4,7	Mean difference is not statistically significant and is not clinically relevant
Adverse Events ‐ not reported	See comment	See comment	Not estimable		See comment	None of the included studies reported any relevant adverse events
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 Working Group grades of evidence. High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: 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: We are very uncertain about the estimate.
¹Serious Inconsistency: due to direction. One of the three studies reported an average effect size that favoured the control; the other two favoured rehabilitation. ²This difference is clinically relevant because it is above the predefined clinically relevant relative difference of 8% to 12%. ³Serious Inconsistency: due to direction and statistical heterogeneity (P = 0.01). Two of the trials reported an average effect size that favoured rehabilitation. The other trial average effect size favoured the control. ⁴Serious Imprecision: 95% CI for the pooled intervention effect could support the rehabilitation group or the control group. ⁵This difference is not clinically relevant because it is below the predefined clinically relevant difference of 30%. ⁶Serious inconsistency: due to direction. Two of the trials reported an average effect size that favoured rehabilitation. The other trial average effect size favoured the control. ⁷Serious inconsistency: Average effects of the two included trials differ in direction.

Summary of findings for the main comparison. Rehabilitation following surgery for lumbar spinal stenosis—short‐term outcomes

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Summary of findings 2. Rehabilitation following surgery for lumbar spinal stenosis—long‐term outcomes

Rehabilitation following surgery for lumbar spinal stenosis—long‐term outcomes
Patient or population: participants with lumbar spinal stenosis Settings: hospital Intervention: rehabilitation after surgery
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No. of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Control	Rehabilitation after surgery
Functional status, long term Oswestry Disability Index (ODI 0 to 100%) or Roland Morris (0 to 24) Follow‐up: 12 months	Mean functional status long term ranged across control groups from 2.04 to 3.32 on log‐scale	Mean functional status long term in the intervention groups was 0.26 standard deviations lower (0.46 to 0.05 lower)		373 (three studies)	⊕⊕⊕⊝ Moderate¹	SMD on the log‐scale corresponds to 23% improvement (5% to 37% improvement) in functional status. This difference is clinically relevant²
Leg pain, long term Visual analogue scale (VAS 0 to 100) Follow‐up: 12 months	Mean leg pain long term ranged across control groups from 3.20 to 3.56 on log‐scale	Mean leg pain long term in the intervention groups was 0.24 lower (0.47 to 0.01 lower)		373 (three studies)	⊕⊕⊕⊝ Moderate¹	MD on the log‐scale corresponds to 21% improvement (1% to 37% improvement) in leg pain. This difference is not clinically relevant³
Low back pain, long term Visual analogue scale (VAS 0 to 100) Follow‐up: 12 months	Mean low back pain long term ranged across control groups from 2.79 to 3.54 on log‐scale	Mean low back pain long term in the intervention groups was 0.2 lower (0.36 to 0.05 lower)		373 (three studies)	⊕⊕⊕⊝ Moderate¹	MD on the log‐scale corresponds to 18% improvement (5% to 30% improvement) in leg pain. This difference is not clinically relevant³
General health, long term Visual analogue scale (VAS 100 to 0) Follow‐up: 12 months	Mean general health long term ranged across control groups from 64 to 70	Mean general health long term in the intervention groups was 0.48 higher (5.44 lower to 6.41 higher)		273 (two studies)	⊕⊕⊝⊝ Low^4,5	Mean difference is not statistically significant or clinically relevant
Adverse event—not reported	See comment	See comment	Not estimable		See comment	None of the included studies reported any relevant adverse events
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 Working Group grades of evidence. High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: 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: We are very uncertain about the estimate.
¹Serious Inconsistency: All studies were agreeable on the direction of the average effect, but only one study identified this to be a significant effect. ²This difference is clinically relevant because it is above the predefined clinically relevant relative difference of 8% to 12%. ³This difference is not clinically relevant because it is below the predefined clinically relevant difference of 30%. ⁴Serious inconsistency: The average effects of the two included trials differ in direction. ⁵Serious imprecision: 95% CI for the pooled intervention effect could support the rehabilitation group or the control group.

Summary of findings 2. Rehabilitation following surgery for lumbar spinal stenosis—long‐term outcomes

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Table 1. Raw summary data

	Aalto 2011				Mannion 2007				McGregor 2010
	Experimental		Control		Experimental		Control		Experimental		Control
Outcome	Mean (SD)	Mean/SD¹	Mean (SD)	Mean/SD¹	Mean (SD)	Mean/SD¹	Mean (SD)	Mean/SD¹	Mean (SD)	Mean/SD¹	Mean (SD)	Mean/SD¹
Short term
Functional status	22.5 (17.8)	1.3	26.4 (19.1)	1.4	8.6 (5.3)	1.6	8.7 (5.8)	1.5	27.0 (18.0)	1.5	32.0 (19.0)	1.7
Leg pain	24.0 (24.0)	1.0	35.0 (29.0)	1.2	29.0 (24.8)	1.2	24.0 (25.0)	1.0	32.0 (27.0)	1.2	38.0 (28.0)	1.4
Back pain	14.0 (18.0)	0.8	20.0 (26.0)	0.8	29.5 (29.0)	1.0	24.3 (26.0)	0.9	33.0 (26.0)	1.3	41.0 (29.0)	1.4
General health					71.5 (20.9)	3.4	74.0 (20.0)	3.7	71.0 (23.0)	3.1	66.0 (24.0)	2.8
Long term
Functional status	24.8 (19.1)	1.3	31.0 (20.1)	1.5	8.9 (6.0)	1.5	9.1 (5.7)	1.6	29.0 (21.0)	1.4	34.0 (22.0)	1.5
Leg pain	28.0 (29.0)	1.0	35.0 (31.0)	1.1	32.5 (28.3)	1.1	33.0 (30.0)	1.1	33.0 (31.0)	1.1	43.0 (30.0)	1.4
Back pain	16.0 (20.0)	0.8	24.0 (26.0)	0.9	28.6 (25.5)	1.1	32.0 (27.0)	1.2	38.0 (30.0)	1.3	42.0 (29.0)	1.4
General health					67.0 (23.9)	2.8	70.0 (22.0)	3.2	67.0 (26.0)	2.6	64.0 (25.0)	2.6
Note: Mean/SD < 2 Indicates skewed data (Higgins 2011).
¹When mean/SD < 2 indicating skewness data was log‐transformed for analysis in accordance with the methods outlined in the Cochrane Handbook for Systematic Reviews of Interventions.

Table 1. Raw summary data

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Table 2. Baseline characteristics of included studies

	Aalto 2011	Mannion 2007	McGregor 2010
Age, years	62.5 (34 to 86; 11.1)	67.1 (10.6)	62 (15)
BMI	29.5 (4.0)	27 (4.5)	27(5)
Gender: female/male	59%/41%	41%/59%	49.5%/51.5%

Table 2. Baseline characteristics of included studies

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Table 3. Outcome variables at baseline

	Aalto 2011		Mannion 2007		McGregor 2010
	Reha mean (SD)	Control mean (SD)	Reha mean (SD)	Control mean (SD)	Reha mean (SD)	Control mean (SD)
Functional status	24.3 (15.9)	29.7 (20,5)	10.9 (4.9)	10.6 (4.7)	30(18)	32(21)
Low back pain (VAS 0 to 100)	16 (19)	20 (26)	24.6 (19.8)	29 (21)	35 (26)	35 (29)
Leg pain (VAS 0 to 100)	27 (26)	32 (28)	29.5 (22.9)	22 (24)	33 (27)	32 (28)
General health (VAS 100 to 0)	‐	‐	68.6 (21)	69 (26)	69 (22)	66 (26)

Table 3. Outcome variables at baseline

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Table 4. Clinical relevance of included studies

	Aalto 2011	Mannion 2007	McGregor 2010
1. Are participants described in detail so that you can decide whether they are comparable with those that you see in your practice?	Yes	Yes	Yes
2. Are the interventions and treatment settings described well enough that you can provide the same for your patients?	Yes	Yes	Yes
3. Were all clinically relevant outcomes measured and reported?	Yes	Yes	Yes
4. Is the size of the effect clinically important?	No	No	No
5. Are the likely treatment benefits worth the potential harms?	Yes	Yes	Yes

Table 4. Clinical relevance of included studies

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Comparison 1. Short term

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Functional status short term (log‐scale) Show forest plot	3	340	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.22 [‐0.44, ‐0.00]

2 Leg pain short term (log‐scale) Show forest plot	3	340	Mean Difference (IV, Random, 95% CI)	‐0.17 [‐0.52, 0.19]

3 Low back pain short term (log‐scale) Show forest plot	3	340	Mean Difference (IV, Fixed, 95% CI)	‐0.18 [‐0.35, ‐0.02]

4 General health Show forest plot	2	238	Mean Difference (IV, Fixed, 95% CI)	1.30 [‐4.45, 7.06]

Comparison 1. Short term

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Comparison 2. Long term

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Functional status long term (log‐scale) Show forest plot	3	373	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.26 [‐0.46, ‐0.05]

2 Leg pain long term (log‐scale) Show forest plot	3	373	Mean Difference (IV, Random, 95% CI)	‐0.24 [‐0.47, ‐0.01]

3 Low back pain long term (log‐scale) Show forest plot	3	373	Mean Difference (IV, Fixed, 95% CI)	‐0.20 [‐0.36, ‐0.05]

4 General health long term Show forest plot	2	273	Mean Difference (IV, Fixed, 95% CI)	0.48 [‐5.44, 6.41]

Comparison 2. Long term

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Rehabilitación posquirúrgica para la estenosis lumbar

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