Is mindfulness-based stress reduction effective for reducing back pain and functional limitations as compared to cognitive behavioral therapy or usual care?
Date of publication of the randomized controlled trial: March 2016
Design
Randomized controlled trial (RCT).
Participants
342 patients aged 20 to 70 years with non-specific low back pain that persisted at least 3 months (mean age: 49.3 years, male %: 34.3%). Individuals with back pain associated with a specific diagnosis, with compensation or litigation issues, who would have difficulty participating, or who rated pain bothersomeness <4 and/or pain interference with activities <3 on 0–10 scales were excluded.
Intervention
Weekly mindfulness-based stress reduction (MBSR) or cognitive behavioral therapy (CBT) was used as interventions. Each session of intervention is 2-hour and duration is 8 weeks.
Comparator
Comparison 1: MBSR versus usual care;
Comparison 2: MBSR versus CBT;
Comparison 3: CBT versus usual care.
Major Outcomes
Outcome 1: Percentage of participants with clinically meaningful (>30%) improvement from baseline in back pain-related functional limitations as assessed by modified Roland Disability Questionnaire (RDQ) at 26 weeks;
Outcome 2: Percentage of participants with clinically meaningful (>30%) improvement from baseline in self-reported back pain bothersomeness at 26 weeks.
Settings
This study was conducted in an outpatient setting.
Comparison    MBSR versus usual care
Main Results
Compared to usual care, MBSR resulted in greater percentage of participants with clinically meaningful improvement on the RDQ (risk ratio (RR): 1.37, 95% CI: 1.06 to 1.77) and pain bothersomeness (RR: 1.64, 95% CI: 1.15 to 2.34).
Comparison 1: MBSR versus usual care in patients with chronic low back pain
Outcomes No. of studies (Total no. of participants) Percentage of participants with clinically meaningful improvement Heterogeneity test (I2) RR (95% CI) Overall quality of evidence*
Intervention Comparator
1 1 (292) 60.5% 44.1% Not applicable as there is only 1 study. 1.37 (1.06 to 1.77) High
2 1 (339) 43.6% 26.6% Not applicable as there is only 1 study. 1.64 (1.15 to 2.34) High
Keys: RR: risk ratio; CI: confidence interval.
Comparison    MBSR versus CBT
Main Results
Compared to CBT, the percentage of participants with clinically meaningful improvement on the RDQ was higher in the MBSR group (risk ratio (RR): 0.95, 95% CI: 0.77 to 1.18). The percentage of participants with clinically meaningful improvement in pain bothersomeness was higher for those who receive CBT (RR: 1.03, 95% CI: 0.78 to 1.36). However, these results did not reach statistical significance.
Comparison 2: MBSR versus CBT in patients with chronic low back pain
Outcomes No. of studies (Total no. of participants) Percentage of participants with clinically meaningful improvement Heterogeneity test (I2) RR (95% CI) Overall quality of evidence*
Intervention Comparator
1 1 (229) 60.5% 57.7% Not applicable as there is only 1 study. 0.95 (0.77 to 1.18) Moderate
2 1 (229) 43.6% 44.9% Not applicable as there is only 1 study. 1.03 (0.78 to 1.36) Moderate
Keys: RR: risk ratio; CI: confidence interval.
Comparison    CBT versus usual care
Main Results
Compared to usual care, the percentage of participants with clinically meaningful improvement on the RDQ was higher for those who received CBT (risk ratio (RR): 1.31, 95% CI: 1.01 to 1.69). The percentage of participants with clinically meaningful improvement in pain bothersomeness at 26 weeks was higher in the CBT group than for usual care (RR: 1.69, 95% CI: 1.18 to 2.41).
Comparison 3: CBT versus usual care in patients with chronic low back pain
Outcomes No. of studies (Total no. of participants) Percentage of participants with clinically meaningful improvement Heterogeneity test (I2) RR (95% CI) Overall quality of evidence*
Intervention Comparator
1 1 (226) 57.7% 44.1% Not applicable as there is only 1 study. 1.31 (1.01 to 1.69) High
2 1 (226) 43.6% 26.6% Not applicable as there is only 1 study. 1.69 (1.18 to 2.41) High
Keys: RR: risk ratio; CI: confidence interval.
Comparison    MBSR versus usual care
Main Results
Compared to usual care, MBSR resulted in greater percentage of participants with clinically meaningful improvement on the RDQ (risk ratio (RR): 1.37, 95% CI: 1.06 to 1.77) and pain bothersomeness (RR: 1.64, 95% CI: 1.15 to 2.34).
Comparison 1: MBSR versus usual care in patients with chronic low back pain
Outcomes 1 2
No. of studies (Total no. of participants) 1 (292) 1 (339)
Percentage of participants with clinically meaningful improvement Intervention 60.5% 43.6%
Comparator 44.1% 26.6%
RR (95% CI) 1.37 (1.06 to 1.77) 1.64 (1.15 to 2.34)
Overall quality of evidence* High High
Keys: RR: risk ratio; CI: confidence interval.
Comparison    MBSR versus CBT
Main Results
Compared to CBT, the percentage of participants with clinically meaningful improvement on the RDQ was higher in the MBSR group (risk ratio (RR): 0.95, 95% CI: 0.77 to 1.18). The percentage of participants with clinically meaningful improvement in pain bothersomeness was higher for those who receive CBT (RR: 1.03, 95% CI: 0.78 to 1.36). However, these results did not reach statistical significance.
Comparison 2: MBSR versus CBT in patients with chronic low back pain
Outcomes 1 2
No. of studies (Total no. of participants) 1 (229) 1 (229)
Percentage of participants with clinically meaningful improvement Intervention 60.5% 43.6%
Comparator 57.7% 44.9%
RR (95% CI) 0.95 (0.77 to 1.18) 1.03 (0.78 to 1.36)
Overall quality of evidence* Moderate Moderate
Keys: RR: risk ratio; CI: confidence interval.
Comparison    CBT versus usual care
Main Results
Compared to usual care, the percentage of participants with clinically meaningful improvement on the RDQ was higher for those who received CBT (risk ratio (RR): 1.31, 95% CI: 1.01 to 1.69). The percentage of participants with clinically meaningful improvement in pain bothersomeness at 26 weeks was higher in the CBT group than for usual care (RR: 1.69, 95% CI: 1.18 to 2.41).
Comparison 3: CBT versus usual care in patients with chronic low back pain
Outcomes 1 2
No. of studies (Total no. of participants) 1 (226) 1 (226)
Percentage of participants with clinically meaningful improvement Intervention 57.7% 43.6%
Comparator 44.1% 26.6%
RR (95% CI) 1.31 (1.01 to 1.69) 1.69 (1.18 to 2.41)
Overall quality of evidence* High High
Keys: RR: risk ratio; CI: confidence interval.
Conclusion
Benefits
Compared to usual care, MBSR or CBT resulted in greater improvement in back pain and functional limitations at 26 weeks among adults with chronic low back pain. However, there is no significant difference between MBSR and CBT. For all outcomes in comparisons 1 and 3, the overall quality of evidence is high. Further research is unlikely to have an important impact on our confidence in this estimate of effect. For all outcomes in comparison 2, the overall quality of evidence is moderate. Further research is fairly likely to have an important impact on our confidence in this estimate of effect.
Harms
No serious adverse events were reported. Thirty participants attending at least 1 MRSR session reported an adverse event (mostly temporarily increased pain with yoga). 10 participants who attended at least 1 CBT session reported an adverse event (mostly temporarily increased pain with progressive muscle relaxation).
Link to Original Article
https://www.ncbi.nlm.nih.gov/pubmed/27002445
The synopsis is based on the following article:
Cherkin DC, Sherman KJ, Balderson BH, Cook AJ, Anderson ML, Hawkes RJ, et al. Effect of mindfulness-based stress reduction vs cognitive behavioral therapy or usual care on back pain and functional limitations in adults with chronic low back pain: A randomized clinical trial. JAMA. 2016 Mar 22;315(12):1240-9.


* Interpretation of quality assessment results:
• Very low: Further research is most likely to have an important impact on our confidence in this estimate of effect.
• Low: Further research is likely to have an important impact on our confidence in this estimate of effect.
• Moderate: Further research is fairly likely to have an important impact on our confidence in this estimate of effect.
• High: Further research is unlikely to have an important impact on our confidence in this estimate of effect.
• Very high: Further research is most unlikely to have an important impact on our confidence in this estimate of effect.

Details of assessment method can be found at Chung VC, Wu XY, Ziea ET, Ng BF, Wong SY, Wu JC. Assessing internal validity of clinical evidence on effectiveness of CHinese and integrative medicine: Proposed framework for a CHinese and Integrative Medicine Evidence RAting System (CHIMERAS). European Journal of Integrative Medicine. 2015 Aug 31;7(4):332-41.