Analgesic gas for rehabilitation of frozen shoulder: Protocol for a randomized controlled trial.

BACKGROUND: There is little evidence regarding the best way to treat adhesive capsulitis. Physical therapy can reduce pain and improve function and range of motion. However, we lack clear indications on the regimen, techniques or intensity of physical therapy to achieve better results. Intensive physical therapy seems to be confined to the later stages of adhesive capsulitis (chronic stage) given that rehabilitation-induced pain could worsen the outcomes. Here we describe a protocol for a study comparing the efficacy of a standardized program of intensive mobilization under analgesic gas to a similar program under placebo gas and questioning the impact of pain.

METHOD/DESIGN: A randomized, double-blind, multicenter study - the MEOPA Trial - was designed to include adults with strictly defined clinical adhesive capsulitis for a 14-day intensive physical rehabilitation program under an equimolar mixture of oxygen and nitrous oxide or sham gas administration. Efficacy will be assessed by the Constant-Murley score. Data for secondary criteria including pain, disability, quality of life and perceived efficacy by the patient or physiotherapist will be collected over 6 months.

DISCUSSION: This randomized controlled trial has been designed to test the effectiveness of intensive physical therapy under a simple and safe analgesic method. This study will also address the effect of pain during rehabilitation in adhesive capsulitis. Furthermore, results from the 6-month multidimensional follow-up of painful mobilization for this condition could be extrapolated to other musculoskeletal conditions.

TRIAL REGISTRATION: ClinicalTrials.gov No. NCT01087229.