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RCT
ACE Report #3147

Improved outcomes with active, cognitive-behavioural, or combined treatment for LBP


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

Active rehabilitation for chronic low back pain: cognitive-behavioral, physical, or both? First direct post-treatment results from a randomized controlled trial

BMC Musculoskelet Disord. 2006 Jan 20;7:5

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Synopsis

227 patients with chronic non-specific low back pain (LBP) were randomized to undergo an active rehabilitation program focused on active physical treatment, cognitive-behavioural treatment, a combination of both, or placed on a waiting list (control group). The primary outcome were subjective variables in pain and function. Results indicated that the two intervention treatments and the combined treatment were effective compared to the control group. No significant clinical differences were seen between the individual interventions and the combination group.

Publication Funding Details +
Funding:
Non-Industry funded
Sponsor:
Zorgonderzoek Nederland/Medische Wetenschappen (ZonMw) and the Rehabilitation Centre Blixembosch
Conflicts:
None disclosed

Risk of Bias

7/10

Reporting Criteria

17/20

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.

4/4

Randomization

3/4

Outcome Measurements

2/4

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?

Low back pain (LBP) is often treated based on three different models: the physical deconditioning model, the cognitive behavioural model and the biopsychosocial model. However, there is a lack of information between what type of treatment is most effective. This study examines the outcomes of treating patients with chronic LBP using physical active rehabilitation, cognitive-behavioural active rehabilitation, a combination of both, or none.

What was the principal research question?

What are the outcomes in pain and function when cognitive-behavioural active rehabilitation, physical active rehabilitation, a combination of both, or no treatment is administered in patients with chronic non-specific low back pain examined immediately post-intervention?

Study Characteristics -
Population:
227 patients with chronic non-specific low back pain. (223 patients treated) (Age: 18-65)
Intervention:
Active physical treatment (APT): Aerobic training and 3 dynamic static strengthening exercises. (Mean age: 42.68 +/-9.06 years) (n=53); Cognitive-behavioural treatment (CBT): Operant behavioural graded activity training and problem solving training. (Mean age: 42.52 +/-9.67 years) (n=58); Combined treatment (CT) (Mean age: 40.67 ± 10.14 years) (n=61) Intervention treatments were prescribed at 3 times a week for 10 weeks.
Comparison:
Waiting list control group (WL): Patients waited 10 weeks before treatment and were not allowed to undergo any therapeutic or diagnostic procedures during the waiting period. (Mean age: 40.55 +/-11.17 years) (n=51)
Outcomes:
Primary outcome: Low back pain associated with functional limitations (Roland Disability Questionnaire (RDQ)); Secondary outcomes: Questionnaires on pain, depression, global assessment, and treatment satisfaction; Physical performance (walking, standing up, reaching forward, stair climbing and lifting).
Methods:
RCT: Multiple centres (3)
Time:
10 weeks (Immediately post-intervention)

What were the important findings?

  • All 3 intervention treatments resulted in significant reductions in functional limitations, patient's main complaints, and pain intensity compared to the waiting list control group.
  • The 3 intervention treatment groups reported higher ratings in the outcomes of self-rated treatment effectiveness and satisfaction.
  • No clinically relevant differences were found between the CT and APT groups, or between CT and CBT groups.
  • APT and CT showed improvements in a number of physical performance tasks, while the CBT group did not.

What should I remember most?

The 3 intervention treatments (active physical treatment, cognitive-behavioural treatment, and combined treatment) demonstrated better outcomes when compared to the waiting list control group. No clinically significant differences were seen when the combined intervention treatments were compared to the individual intervention treatements.

How will this affect the care of my patients?

Undergoing active physical treatment, cognitive-behavioural treatment, or a combined treatment of both may provided improvements in functional limitations and pain intensity for patients suffering from chronic non-specific low back pain.

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