Osteopathic Manipulative Therapy and Multiple Sclerosis: A Proof-of-Concept Study

Methods

This retrospective analysis included patients who were evaluated at the neurology clinic at Genoa University in Italy from August 2013 to the time of this study. The study was conducted in accordance with the Declaration of Helsinki, and all participants provided written informed consent. Patients eligible for inclusion in the study were aged between 20 and 55 years, met the modified McDonald diagnostic criteria for MS,⁴ had an Extended Disability Status Score (EDSS)⁵ between 0 and 6, were relapse-free for the past 4 weeks, and provided informed consent. The patients also had to have a Symbol Digit Modalities Test (SDMT)⁶ score higher than the fifth percentile of the Italian normative data SDMT score (ie, >37.9). The exclusion criteria for participation were as follows: previously reported or recorded diagnoses of life-threatening or severely disabling physical disorders other than MS, use of psychotropic medications to manage psychiatric disorders, change in MS medication in the past 3 months, other disorders of the central nervous system, and pregnancy.

Participants self-selected into a control group or an OMTh group. Each participant, in addition to receiving conventional care, underwent 5 forty-minute sessions once per week during the 1-month study period. Participants in the control group received MS health education during each session. These sessions, conducted by neurology residents, comprised Microsoft PowerPoint presentations on MS epidemiology, symptoms, diagnosis, treatment, and rehabilitation. Participants in the OMTh group underwent an osteopathic structural examination (OSE) at each session to locate and diagnose the presence of somatic dysfunction, and they received OMTh based on the OSE findings in each session. The operator (A.A. or J.V.) started the OSE at the participant's skull, continuing with the spine and the pelvis, passing through the upper and lower limbs, and ending with the rib cage and viscera. During the OSE, the operator applied only passive techniques, as they do not require the active collaboration of the subject. Osteopathic manipulative therapy techniques performed during the sessions included myofascial release, balanced ligamentous tension, balanced membranous tension, and craniosacral.

The neurologists (C.C. and M.P.) performed neurologic evaluation and EDSS assessment before the first session, 1 week after the final session, and 6 months after the final session. The EDSS scale ranges from 0 to 10 in 0.5-unit increments that represent higher levels of disability. At these times, participants also completed a questionnaire that assessed fatigue, depression, anxiety, and quality of life. Fatigue was measured with a modified form of the Modified Fatigue Impact Scale (MFIS),⁹ which has a score range of 0 to 84. Higher scores indicate more severe fatigue.¹² Depression was measured using the Beck Depression Inventory-II (BDI-II),⁸ with a score range of 0 to 54. Scores from 0 to 6 indicate no depression; 7 to 17, mild depression; 18 to 24, moderate depression; and over 24, severe depression.¹¹ Anxiety was measured using the Beck Anxiety Inventory (BAI).¹⁰ The BAI has a score range of 0 to 63, in which scores from 0 to 9 indicate no anxiety; 10 to 18, mild to moderate anxiety; 19 to 29, moderate to severe anxiety; and 30 to 63, severe anxiety.¹³ Quality of life was measured with the 12-item Short Form Health Survey (SF-12), a shorter alternative to the SF-36 (1 of the 10 individual scales in the Multiple Sclerosis Quality of Life Survey).⁷ The SF-12 allows the calculation of physical and mental index scores. Higher scores indicate better quality of life. Investigators who administered the questionnaires (M.P., D.S., M.T.I., A.T., C.L., M.C., V.C.) were blinded to the participants’ group assignments.

Descriptive statistics for participant characteristics were presented either as percentages or mean (SD). Linear regression models were used to compare the change from the baseline value of each variable being measured between the control group and the OMTh group at different time points. P≤.05 was considered statistically significant.

Results

Of 55 potential participants, 22 were included in the study. Ten participants were in the control group (including 2 with relapsing-remitting MS, 1 with clinically isolated syndrome, and 1 with secondary progressive MS), and 12 were in the OMTh group (including 9 participants with relapsing-remitting MS, 1 with secondary progressive MS, and 1 with primary progressive MS) (Table 1).

Raw scores for each participant revealed a wide range of baseline scores on the MFIS, BDI-II, and BAI in both groups (Table 2). One week after the final session, the OMTh group had a statistically significant improvement in MFIS and BDI-II scores (P=.002 and P<.001, respectively). Additionally, an improvement in SF-12 scores in the OMTh group was noted 1 week after the final session, but the difference was not statistically significant (P=.36) (Table 3). Six months after the final session, no statistically significant difference between the OMTh and control groups was observed (data not shown).

Discussion

Many patients with MS use adjunctive treatments to supplement traditional treatment.¹⁴ Results of the current study showed that OMTh is effective in improving self-reported fatigue and depression in patients with MS and that there was a trend in improvement in quality of life. Our results confirm the findings of Yates et al,¹⁵ who found that osteopathic manipulative treatment combined with maximal-effort exercise reduced fatigue in 7 women with multiple sclerosis. Results showed a decrease in fatigue in 5 of 7 women and a significant increase in strength and ambulatory levels.¹⁵

Fatigue is the most common symptom in patients with MS.¹⁶ There is currently no satisfactory pharmacologic treatment option for patients with MS-related fatigue. Demonstration of the efficacy of an intervention in reducing fatigue can help clinicians to better manage this disabling symptom. We believe that the short-term improvement in symptoms observed in this study is a clinically important finding. The lack of statistical significance at 6 months suggests that the effect of the OMTh is temporary, and OMTh should be continued to stabilize the improvement in fatigue and depression.

Our study has several limitations. The primary limitations are the nonrandomized allocation of study groups, the small size of the study sample, and the use of self-reported data via questionnaires, which are less reliable than clinician-administered instruments. Future studies are needed to evaluate precisely how long improvement with OMTh lasts and how it can be optimized to maintain improvements, as well as to replicate these findings in a larger sample.

Conclusion

Adjunctive OMTh can be a useful tool for the management of chronic MS symptoms, particularly in patients with fatigue and depression. Of course, these results need to be replicated in randomized trials. If so, OMTh, as an intervention with minimal adverse effects, can be implemented as an adjunct to pharmacotherapy.

Author Contributions

All authors provided substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; all authors drafted the article or revised it critically for important intellectual content; all authors gave final approval of the version of the article to be published; and all authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.