Osteopathic medicine for fibromyalgia, a sham-controlled randomized clinical trial

Participants

• Number: 101 people (95 female and 6 male)
• Criteria of inclusion: adults (> 18 years); fibromyalgia diagnosed for more than 1 year according to the criteria of the American College of Rheumatology set in 1990; average pain with an intensity greater than 50/100 according to VAS; stable pharmacological and non pharmacological treatments (that is without changes) for more than 1 month; no history of severe psychiatric conditions (major depression, psychosis); if women, neither pregnant nor breastfeeding; no physical treatment (physiotherapy, osteopathy, chiropractic, manual therapies) in the 3 months preceding the study; no participation in other studies; possibility to be present at all treatment sessions and checkups; health insurance coverage
• Criteria of exclusion: those who did not meet the above criteria were excluded from the study
• Groups of study: two groups obtained by randomization
  • Group 1: OMT, 51 people (48 female and 3 male, mean age 51)
    • 42 people followed the whole therapy and 29 attended all the check-ups
  • Group 2: sham treatment, 50 people (47 female and 3 male, mean age 50)
    • 36 people followed the whole therapy and 23 attended all the check-ups

Interventions and evaluations

• At the beginning of the study, assessment of the credibility of the treatment and expectations through the Credibility/expectancy questionnaire (CEQ)
• At the beginning of the study, assessment of pain through VAS, of symptoms of anxiety and depression through Hospital Anxiety and Depression scale (HAD), of the beliefs related to fear of movement due to pain through Fear-Avoidance Beliefs Questionnaire (FABQ), of the catastrophization (pessimism) related to pain through the Pain Catastrophizing Scale (PCS), of the sense of fatigue through MFI-20, of the impact that fibromyalgia has on daily life through FIQ and of the quality of life through SF-36
• At weeks 6, 12, 24 and 52, assessment of pain through VAS, of sense of fatigue through MFI-20, of impact of fibromyalgia on daily life through FIQ, of quality of life through SF-2036, of feelings of improvement or worsening through PGIC and of adverse effects
• 1 therapy session of 15-20 minutes per week for 6 weeks, 3 control visits at 12, 24 and 52 weeks from the start of the study
• OMT: mobilizations and light stretching at cervical, dorsal, lumbar, sacrum, shoulders and hips’ level; thrust where considered appropriate
• Sham: identical maneuvers applied in the OMT but blocked in half to prevent proper mobilization and stretching; no thrust

Results

• Primary outcomes: OMT has favored a greater reduction in pain compared to sham treatment, a reduction that lasted until the last checkup. However, the result was not statistically significant.
• Secondary outcomes: the OMT appears to improve quality of life (SF-36) in relation to the condition more than sham treatment, while the two groups had similar results in reducing fatigue (MFI-20) and improving functional status (FIQ).

Neither the OMT nor the sham treatment caused serious adverse effects: only the group that received the OMT, at the 12-week checkup, reported a slight increase in pain and a worse functional status.
Improvement expectations have particularly affected pain during the treatment period, while both expectations and credibility of treatment have partially affected quality of life, fatigue and functional status.

Discussion

Many people with fibromyalgia consult osteopaths to improve their living conditions because the classic pharmacological therapies (antidepressants and analgesics) have few benefits. Several studies on the subject have reported contradictory results, most likely due to the recruitment of few people and a low-quality methodology.

This study too shows contradictory results, potentially for the same reasons: at least 130 people should have been recruited, while only 101 had been recruited. The OMT thus seems capable of reducing pain symptoms, but not in a different way (according to statistical calculations) compared to the sham treatment.

Interesting is the datum on the importance of improvement expectations in the treatment: people with higher expectations of improvement have reported a greater decrease in pain, especially during the period of treatment.