Mind Over (Back Pain) Matter: An RCT
April 1, 2016 8 minutes read
By David Kiefer, MD, Editor
SUMMARY POINTS
- These researchers randomized 282 adults with chronic low back pain to either 8 weeks of mindfulness meditation training (fashioned after the MBSR course) or a “control” educational program.
- At the end of the intervention (8 weeks), the MBSR group fared better in the Roland and Morris Disability Questionnaire, but this improvement disappeared by 6 months post-intervention.
- The MBSR group showed some improvements at both 8 weeks and 6 months in sub-types of pain (current and most severe).
SYNOPSIS: Mindfulness meditation training led to greater short-term function and less pain in adults with chronic low back pain when compared to a control group receiving only educational sessions.
SOURCE: Morone NE, et al. A mind-body program for older adults with chronic low back pain: A randomized clinical trial. JAMA Intern Med 2016;176:329-337.
Chronic low back pain afflicts many adults, a fact to which any clinician in primary care would attest. It is one of the most common reasons people turn to integrative therapies,1 and has been widely studied to find effective treatments. The study reviewed here, financed by the National Institutes of Health, adds to the literature on the use of mind-body medicine for this condition.
The researchers randomized 282 English-speaking adults older than 65 years of age to either 8 weekly 90-minute mindfulness meditation sessions or “control” education sessions. Participants were included in or excluded from the trial as per the criteria in Table 1.
TABLE 1: INCLUSION EXCLUSION CRITERIA |
|
|
Inclusion Criteria |
Exclusion Criteria |
* This was a self-rated, five-part scale: extreme, severe, moderate, mild, no pain |
|
Functional limitation was measured using the Roland and Morris Disability Questionnaire (RMDQ), a 0-24 scale with higher numbers representing more disability. The mindfulness meditation sessions were fashioned after the mindfulness-based stress reduction (MBSR) program, a well-known and studied series of sessions that explores the aspects of four methods of mindfulness meditation. The “control” education session was a group health education program called “10 Keys to Healthy Aging,” which provided 10 trainings on disease prevention surrounding blood pressure control, smoking cessation, cancer screening, immunizations, activity, cholesterol and glucose control, depression, healthy bones, and staying socially connected. Both groups also had six monthly “booster” classes at the end of the 8 weeks to reinforce the trainings and encourage participation.
The primary outcome for this study was the RMDQ, as described above. It was thought, based on prior work, that an improvement (lowering) of the RMDQ by 2.5-5.0 points would be clinically meaningful. Secondary outcomes assessed for pain, quality of life, depression, self-efficacy (to predict task performance), pain catastrophizing, and mindfulness, as per the validated scales listed in Table 2. All of the variables were assessed at the end of the program (8 weeks after the study began) and then 6 months after the study ended.
TABLE 2: SECONDARY OUTCOMES AND VALIDATED SCALES USED TO QUANTIFY VARIABLES |
|
|
Secondary Outcomes |
Validated Scale Used to Qualtify Secondary Outcomes |
|
Pain (present, average, and most severe during the week) |
Numeric Pain Rating Scale: range 0-20, higher number for more pain |
|
Quality of life |
RAND-36 Health Status Inventory (Global Health Composite: range 9-67, higher number for better overall health; Physical Health Composite: range 20-65, higher number for better physical health) |
|
Depression |
Geriatric Depression Scale: range 0-30, higher number for worse depression |
|
Self-efficacy |
Chronic Pain Self-Efficacy Scale: range 0-100%, higher numbers for improved self-efficacy |
|
Pain catastrophizing |
Catastrophizing Scale of the Coping Strategies Questionnaire: range 0-6, higher number for more catastrophizing |
|
Mindfulness |
Mindful Attention Awareness Scale: range 1-6, higher numbers for more mindfulness |
|
Comorbidities |
Cumulative Illness Rating Scale: range 0-13, higher numbers for more comorbid conditions |
Of the 282 people randomized, 140 were in the MBSR group, and 142 were in the control group. All 282 were included in the final analysis of the primary outcome (intention-to-treat), even though only 118 in the MBSR group and 135 in the control group made it to the 6-month assessment. As would be expected, there was a better adherence to the protocol through 8 weeks: 132 people in the MBSR group and 138 in the control group. The researchers adeptly account for all dropouts in an included figure.
Baseline characteristics were statistically similar between the MBSR and control groups, including a relatively high baseline mindfulness score (4.6 and 4.4 in the treatment and control groups, respectively). Participants attended an average of 6.6 (out of eight) sessions and 2.4 (out of six) “booster” classes. Table 3 lists the RMDQ values for the different time points for each group, essentially showing a more significant lowering of the RMDQ for the MBSR group at the 8-week mark compared to the control group, a difference that was not sustained at 6 months. At the 8-week time point, 56.8% of the MBSR group and 44.9% of the control group achieved a 2.5 point improvement in the RMDQ, considered the cutoff for clinically significant findings. Of note, these percentages were not statistically different (P = 0.51). There were also a few participants who had at least a 2.5 point worsening in their RMDQ: in the MBSR, 5.3% (8 weeks) and 5.1% (6 months), and in the control group, 4.3% (8 weeks) and 4.4% (6 months).
TABLE 3: RMDQ (PRIMARY OUTCOME), RESULTS FOR MBSR vs CONTROL GROUP |
||||||
|
MBSR |
MBSR |
MBSR |
Control baseline |
Control |
Control |
|
|
RMDQ |
15.6 |
12.1 |
12.2 |
15.4 |
13.1 |
12.6 |
|
RMDQ: Roland and Morris Disability Questionnaire; MBSR: mindfulness-based stress reduction |
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For the secondary outcomes, the data of which are too voluminous to present here, there were some statistically significant improvements but few clinically significant effects. For example, the average Numeric Pain Rating Scale did not differ between the MBSR or control groups, although the Numeric Pain Rating Scale sub-groups of current and most severe pain over the last week was statistically and clinically significantly better in the MBSR group at both 8 weeks and 6 months. In addition, patient self-efficacy in the MBSR group improved more than the control group, but only at 8 weeks. Psychological measures and quality of life showed statistically significant, but not clinically significant, improvements in the MBSR group.
Finally, at 8 weeks each participant was asked the following question: “How much have your back symptoms changed as a result of the treatment provided in this study?” Termed “global impression,” reported improvement in back pain was significantly greater in the MBSR group compared to the control group (P < 0.001). This perceived improvement persisted in the MBSR group at 6 months, while more participants in the control group reported worsening symptoms.
COMMENTARY
People with chronic low back pain commonly turn to the healthcare system for help. This study offers some ideas about what role mindfulness meditation might serve for this population. Most importantly, in the short term, function (less disability) is improved after an 8-week MBSR class. The researchers noted that this effect wasn’t sustained, in comparison to the control group, at the 6-month mark. Were the participants in this study group going to improve anyway, regardless of the treatment offered? The researchers had strict inclusion criteria meant to find those adults with chronic pain, so that does not seem to be the explanation. Interestingly, the effect of the MBSR training on two subsets of pain did remain statistically and clinically significantly improved at 6 months, so some aspects of the MBSR training persist. One of the concluding sentences explores the need to adjust the training so that it persists longer; this would definitely be important.
It is difficult to tease out clinical pearls from the myriad of tests used to assess the secondary variables. It is possible, given the high baseline mindfulness scores in all participants, the extra “boost” to mindfulness given by the MBSR class was not sufficient to show benefits compared to the educational intervention. A somewhat concerning research finding was the high number of participants who were lost to follow-up at 6 months in the MBSR group. The researchers used intention-to-treat analyses, so these data were handled appropriately, but it still begs the question of how the data would have changed if all of the participants in the MBSR group had been located and analyzed at the 6-month mark. At least the adherence to the MBSR class was high; clinicians can feel confident that, if recommended, patients will stick to this approach for 8 weeks, at least according to this study.
In some cases, perception is everything. With respect to the MBSR group, the global impression results were unequivocally better. Perhaps this is just what someone with chronic low back pain needs — a new outlook, hope, or a change in the status quo. In other words, even if the pain doesn’t appreciably change, one’s ability to cope with that pain improves, and that translates into an overall benefit. Perhaps less quantified than the rest of the study, this is nonetheless important and deserves attention.
Is there any reason not to recommend MBSR, or other versions of mindfulness meditation, for people with chronic low back pain? Cost, possibly, or inconvenience (90 minutes weekly for 8 weeks). Some participants showed a worsening of their RMDQ over time, but this also occurred in the control group. It would be difficult to call this an adverse effect; rather some patients, despite our best efforts, may be resistant to clinical improvement.
Overall, mindfulness meditation is worth exploring for patients with chronic low back pain. It may bring improvements in function, if not persistent benefits in pain and impressions of overall improvement. Hopefully, all clinicians have access to MBSR or related trainings to which they can refer patients who fit the bill.
REFERENCE
- Barnes PM, et al. Complementary and alternative medicine use among adults and children: United States, 2007. Natl Health Stat Report 2008 Dec 10;(12):1-23.
Mindfulness meditation training led to greater short-term function and less pain in adults with chronic low back pain when compared to a control group receiving only educational sessions.
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