Impact of Osteopathic Treatment on Pain in Adult Patients with Cystic Fibrosis – A Pilot Randomized Controlled Study

<div><p>Background</p><p>Pain is a common complication in patients with cystic fibrosis (CF) and is associated with shorter survival. We evaluated the impact of osteopathic manipulative treatment (OMT) on pain in adults with CF.</p><p>Methods</p><p>A pilot multicenter randomized controlled trial was conducted with three parallel arms: OMT (group A, 16 patients), sham OMT (sham treatment, group B, 8 patients) and no treatment (group C, 8 patients). Medical investigators and patients were double-blind to treatment for groups A and B, who received OMT or sham OMT monthly for 6 months. Pain was 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.</p><p>Results</p><p>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.</p><p>Conclusion</p><p>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.</p><p>Trial Registration</p><p>ClinicalTrials.gov <a href="http://clinicaltrials.gov/ct2/show/NCT01293019" target="_blank">NCT01293019</a></p></div

Baseline characteristics of the study participants.

<p>Baseline characteristics of the study participants.</p

Mean neck/trapezius pain and headache between the first and the final visit for the treatment group and the control group.

#<p>The difference (95% confidence interval) between Groups A and B+C was not significant: 1.51 (−0.97; 3.98)– p = 0.228.</p>##<p>The difference (95% confidence interval) between Groups A and B+C was not significant: −1.30 (−3.27; 0.66)– p = 0.190.</p

Need for analgesics in the OMT group, the sham OMT group and the group with usual care.

<p>Need for analgesics in the OMT group, the sham OMT group and the group with usual care.</p

Composite chest/back pain at inclusion (M0), after 3 months (M3) and at the end of the study (M6) in the OMT group (A) and control group (B+C).

<p>VAS: visual analog scale.</p

Composite neck/trapezius pain and headache at inclusion (M0), after 3 months (M3) and at the end of the study (M6) in the OMT group (A) and control group (B+C).

<p>VAS: visual analog scale.</p

Flow chart.

<p>Flow chart.</p

Composite chest/back pain at inclusion (M0), after 3 months (M3) and at the end of the study (M6) in the OMT group (A), the OMT sham group (B) and the group with only usual treatment (C).

<p>VAS: visual analog scale.</p

Change in the primary outcome measure (composite chest/back pain) between the first and the final visit in the three treatment groups and comparisons between groups.

<p>SD: standard deviation.</p><p>95% CI: 95% confidence interval.</p

Vaccination status according to A/H1N1 vaccination status.

<p>Vaccination status according to A/H1N1 vaccination status.</p