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RCT
ACE Report #867

Various rehabilitation programs and no treatment comparable after spinal decompression


Study Type:Therapy
OE Level Evidence:2
Journal Level of Evidence:N/A

A randomised controlled trial of post-operative rehabilitation after surgical decompression of the lumbar spine

Eur Spine J. 2007 Aug;16(8):1101-17. Epub 2007 Jun 26

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Synopsis

167 patients with degenerative spinal disease (spinal stenosis/herniated disc) undergoing decompression surgery were randomized to either receive physiotherapy with stabilization exercises, physiotherapy with mixed techniques or no therapy/self management. The results indicated that both physiotherapy with spine stabilization exercises and physiotherapy with mixed techniques were not superior to advice to remain active with enjoyable activities (control).

Publication Funding Details +
Funding:
Non-Industry funded
Sponsor:
Swiss National Science Foundation and the Schulthess Klinik Research Funds
Conflicts:
None disclosed

Risk of Bias

5/10

Reporting Criteria

16/20

Fragility Index

N/A

Was the allocation sequence adequately generated?

Was allocation adequately concealed?

Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?

Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?

Blinding Patients: Was knowledge of the allocated interventions adequately prevented?

Was loss to follow-up (missing outcome data) infrequent?

Are reports of the study free of suggestion of selective outcome reporting?

Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?

Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?

Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?

Yes = 1

Uncertain = 0.5

Not Relevant = 0

No = 0

The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.

2/4

Randomization

2/4

Outcome Measurements

4/4

Inclusion / Exclusion

4/4

Therapy Description

4/4

Statistics

Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65

The Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.

Why was this study needed now?

Degenerative lumbar spine diseases that cause compression of the neural elements occur frequently in the ageing population. The symptoms and consequences that result from such diseases negatively impact the affected individual's ability to perform activities of daily living, and compromise their independence. Surgery is often required for these cases, and the success rates of surgery are reportedly low. The use of active rehabilitation programs following spinal surgery has proven to have benefits in younger patient populations, however it's use in elderly patients remains uncertain.

What was the principal research question?

How do the outcomes compare between no supervised therapy, physiotherapy with spine stabilization exercises, or physiotherapy with mixed techniques are performed following decompression surgery, in patients with degenerative spinal disease, measured over 2 years?

Study Characteristics -
Population:
167 patients with degenerative spinal disease (spinal stenosis/herniated disc) undergoing decompression surgery (n=159 completed follow-up)
Intervention:
Spine Stabilisation Physio Group: Patients allocated to the first treatment group received physiotherapy with spine stabilization exercises from a trained physiotherapist, for 12 weeks (30 minute sessions, twice per week) (n=57, 56 completed follow-up; Mean Age: 64.2 SD 11.0 years; M/F=36/20). Mixed Methods Physio Group: Patients allocated to the second treatment group received physiotherapy with mixed techniques for 12 weeks (30 minute sessions, twice per week). The physiotherapist used the treatment that they believed would be most appropriate for the patient (n=54, 49 completed follow-up; Mean Age: 64.7 SD 10.5 years; M/F=30/19).
Comparison:
Control Group (self-management): The control group received no therapy following surgery (self-management for 12 weeks). No specific exercises were given, and these patients were instructed to do activities/exercises that they enjoy (n=56, 54 completed follow-up; Mean Age: 65.7 SD 10.8 years; M/F=34/20).
Outcomes:
Primary outcomes include functional disability (measured using the Roland Morris Disability Score), pain intensity (Graphic Rating Scale) and global outcome assessment.
Methods:
RCT; Single Centre; Non-Blinded
Time:
Outcomes assessed pre-operatively, before and after rehabilitation phase (2 and 5 months), and at 12 and 24 months after surgery.

What were the important findings?

  • Following surgery, a significant reduction (p<0.05) in the Roland Morris Disability Scores was observed, however there were no significant differences between the two groups (p>0.05). Between first (pre-rehab) and second (post-rehab) follow up periods, a further reduction in disability was observed with no significant differences between groups (p>0.05).No significant changes were observed up until the 24 month follow up period. (p>0.05)
  • After surgery, both groups showed a significant reduction (p<0.05) in leg pain, back pain, and all average pain scores. Leg pain remained constant over the rehabilitation phase, but a significant increase (in all groups; each p<0.05) was observed from end of rehab to 12 month follow up. Until the 24 month period, leg pain was stable.
  • At 2, 12 and 24 months after surgery, there were no significant differences between groups in terms of global outcome assessments (p>0.05).

What should I remember most?

In comparison to no therapy/self-management, supervised physiotherapy demonstrated no significant influence on the change in pain and disability scores, up to 24 months following surgery.

How will this affect the care of my patients?

Regardless of the therapy given, this study shows that patients still experience moderate disability in their every day life, resulting from back issues. Encouraging patients to continue with activities they enjoy doing, may be as effective as a supervised physiotherapy program- with low-cost to the health-care provider. Further large-scale, high-quality evidence is needed to validate these findings.

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