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RCT
ACE Report #9037

Cognitive-behavioural therapy vs. control for pain reduction after lumbar spinal fusion


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

Preoperative cognitive-behavioural intervention improves in-hospital mobilisation and analgesic use for lumbar spinal fusion patients

BMC Musculoskelet Disord. 2016 May 20;17(1):217

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Synopsis

90 patients with degenerative spinal disorders undergoing lumbar spinal fusion were randomized to receive either cognitive-behavioural therapy or standard treatment. The objective of this study was to determine whether or not cognitive-behavioural therapy (CBT) has the ability to affect early postoperative outcomes such as back pain, mobility, analgesic consumption, and hospital stay duration. Findings indicated no significant differences between groups for improvement in postoperative back pain, analgesic consumption, and length of hospitalization. However, mobility was significantly improved in the CBT group compared to the control group by postoperative day 3.

Publication Funding Details +
Funding:
Non-Industry funded
Sponsor:
Danish Council for Strategic Research, the Health Research Fund of Central Denmark Region, the Danish Rheumatism Association and the Health Foundation
Conflicts:
None disclosed

Risk of Bias

4.5/10

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.

3/4

Randomization

2/4

Outcome Measurements

4/4

Inclusion / Exclusion

4/4

Therapy Description

3/4

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?

Psychological factors such as fear-avoidance belief and catastrophic thinking are believed to limit postoperative recovery and heighten pain. Cognitive-behavioural therapy (CBT) has been suggested to combat these negative thoughts. Previous trials have found inconclusive results of CBT on pain after lumbar spinal fusion due to the administration of the therapy postoperatively. Therefore, the present study attempts to study the effects of CBT on pain after lumbar spinal fusion when administered preoperatively.

What was the principal research question?

In the treatment of patients undergoing lumbar spinal fusion surgery, does the addition of cognitive-behavioural therapy to standard treatment prior to the operative procedure reduce the intensity of back pain within the first postoperative week?

Study Characteristics -
Population:
90 patients with undergoing lumbar spinal fusion surgery were included. Eligible patients were between the ages of 18 and 64 years and had either primary degenerative disc disease, stenosis or spondylolisthesis grade 1-2, and a maximum of 3 fusion levels.
Intervention:
Cognitive-behavioural group: Patients received standard treatment as well as four 3-hour sessions pertaining to the interaction between cognition and pain perception, coping strategies, pacing principles, ergonomic directions, return to work, and information on the surgical procedure. These sessions were hosted by a team which included a psychologist, an occupational therapist, a physical therapist, a spine surgeon, a social worker, and a previous patient. (n=63; Mean age: 51.4 +/- 9.2)
Comparison:
Control group: Patients received standard treatment which comprised of preoperative information delivered by the surgeon, nurses, and therapists about the surgical procedure, anesthesia, medication, and postoperative therapy and protocols. (n=33; Mean age: 47.7 +/-8.9)
Outcomes:
Primary outcome included the severity of immediate back pain assessed with the numeric rating scale (NRS). The International Association for the Study of Pain (IASP) was used to calculate the median pain score within the first postoperative week. Secondary outcomes consisted of postoperative mobility measured using the Cumulated Ambulation Score (CAS), rescue analgesics use beyond the standardized protocol, and length of hospitalization.
Methods:
RCT
Time:
The severity of back pain was assessed throughout the first postoperative week. Postoperative mobility assessed by the CAS was recorded on the first 3 postoperative days.

What were the important findings?

  • No significant differences were reported for back pain severity between the CBT group and the Control group (Median: 5.6 [1.7-10.0] vs. 5.3 [1.1-7.7]; p=0.74)
  • Significantly more patients in the CBT group were able to walk on day 3 compared to the Control group (43 [73%] vs. 15 [48%]; p=0.02); ability to walk was also significantly greater in the CBT group on day 2 (p<0.05), but comparable to the Control group on day 1
  • Significantly more patients in the CBT group were able to rise and sit from a chair, and get in and out of bed on day 3 compared to the Control group (both 58 [98%] vs. 26 [84%]; p=0.017); however, both groups were comparable on postoperative days 1 and 2 (p>0.05)
  • Analgesic use of morphine equivalents was similar between the CBT group and the Control group (Median: 142.5 vs. 196.8; p=0.23)
  • Hospitalization duration was similar between CBT and Control groups (Median: 5 [3-9] vs. 4 [3-10]; p=0.46)

What should I remember most?

In the treatment of lumbar spinal fusion, cognitive-behavioural therapy (CBT) did not significantly improve back pain severity compared to standard treatment. Mobility in terms of walking, rising and sitting from a chair, and getting in and out of bed were all significantly improved in the CBT group compared to the Control group by the third postoperative day.

How will this affect the care of my patients?

The results of this study suggest that CBT may not be effective for improving postoperative back pain compared to standard treatment in patients undergoing lumbar spine fusion, but may be effective for improved postoperative mobility. Further research is necessary to determine a treatment that is able to better manage postoperative back pain in patients with degenerative spinal disorders.

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