Study design (if review, criteria of inclusion for studies)
Pilot multicenter randomized controlled trial with three parallel arms
Participants
Adults with CF. OMT group A 16 patients, sham OMT group B 8 patients, no treatment group C 8 patients.
Interventions
OMT (group A, 16 patients), sham OMT (sham treatment, group B, 8 patients) and no treatment (group C, 8 patients).
Outcome measures
Pain, rated as a composite of its intensity and duration over the previous month. The evolution of chest/back pain after 6 months was compared between group A and groups B+C combined (control group). The evolution of cervical pain, headache and quality of life (QOL) were similarly evaluated.
Main results
There was no statistically significant difference between the treatment and control groups in the decrease of chest/back pain (difference = -2.20 IC95% [-4.81; 0.42], p = 0.098); also, group A did not differ from group B. However, chest/back pain decreased more in groups A (p = 0.002) and B (p = 0.006) than in group C. Cervical pain, headache and QOL scores did not differ between the treatment and control groups.
Authors' conclusions
This pilot study demonstrated the feasibility of evaluating the efficacy of OMT to treat the pain of patients with CF. The lack of difference between the group treated with OMT and the control group may be due to the small number of patients included in this trial, which also precludes any definitive conclusion about the greater decrease of pain in patients receiving OMT or sham OMT than in those with no intervention.
Keywords: Adult; Aged; Arthritis-arthropathy; Back Pain; non pharmacological intervention - complement med; Osteopathic treatment; placebo; Complementary medicine;