title: Impact of osteopathic treatment on pain in adult patients with cystic fibrosis--a pilot randomized controlled study.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  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.
  
  
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01293019.
authors.affiliation: Adult CF Center and Pulmonology Department, Hôpital Cochin APHP, Paris, France; Université Paris Descartes, Sorbonne Paris Cité, Paris, France.
authors.forename: Dominique
authors.initials: D
authors.lastname: Hubert
authors.affiliation: Clinical Research Department, Hôpital Cochin APHP, Paris, France.
authors.forename: Lucile
authors.initials: L
authors.lastname: Soubeiran
authors.affiliation: Clinical Research Department, Hôpital Cochin APHP, Paris, France.
authors.forename: Fabrice
authors.initials: F
authors.lastname: Gourmelon
authors.affiliation: Adult CF Center and Pulmonology Department, Hôpital Foch, Suresnes, France.
authors.forename: Dominique
authors.initials: D
authors.lastname: Grenet
authors.affiliation: Clinical Research Department, Hôpital Cochin APHP, Paris, France.
authors.forename: Raphaël
authors.initials: R
authors.lastname: Serreau
authors.affiliation: Clinical Epidemiology Center, Hôpital Hôtel Dieu APHP, Paris, France.
authors.forename: Elodie
authors.initials: E
authors.lastname: Perrodeau
authors.affiliation: A.T. Still Research Institute, A.T. Still University, Kirksville, Missouri, United States of America.
authors.forename: Rafael
authors.initials: R
authors.lastname: Zegarra-Parodi
authors.affiliation: Clinical Epidemiology Center, Hôpital Hôtel Dieu APHP, Paris, France; Université Paris Descartes, Sorbonne Paris Cité, Paris, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Boutron
mesh_terms: D000328:Adult; D001416:Back Pain / Q000473:pathology; D002637:Chest Pain / Q000473:pathology; D003550:Cystic Fibrosis / Q000473:pathology*; D006261:Headache / Q000473:pathology; D006801:Humans; D026301:Manipulation, Osteopathic / Q000379:methods*; D059408:Pain Management / Q000379:methods*; D010865:Pilot Projects; D011788:Quality of Life / Q000523:psychology