Nitrous oxide provided during intensive physiotherapy for shoulder adhesive capsulitis does not improve function: A randomised controlled trial.

BACKGROUND: There is no consensus on treatment for adhesive capsulitis of the shoulder. Physiotherapy is often used to increase range of motion but individuals may experience pain during mobilisation. OBJECTIVES: The objective of this study was to determine whether rehabilitation under N2O for shoulder AC improved pain and function more than rehabilitation alone (with placebo gas). METHOD: A randomised, 1:1 parallel arm, double-blind study in 4 university hospital outpatient centres. Adults with adhesive capsulitis for at least 3 months with intact cartilage were included. Participants were randomised in blocks of 4 and stratified by centre to receive 20 sessions of intensive physiotherapy over 10 days; the 10 morning sessions were performed with either nitrous oxide (intervention) or sham gas (placebo). PRIMARY OUTCOME: improvement in shoulder function at day 14 (D14) (Constant-Murley score). RESULTS: Seventy-five participants were included, and data from 69 were analysed: 37 in the placebo group and 32 in the intervention group. Improvements occurred in both groups after the intervention. No significant difference in the Constant-Murley score was found between groups at D14 (median score increase of 12.0, IQR 5.6; 19.5 points in placebo group vs. 13.7, 5.2; 18.2 in the N20 group, p = 0.78). Pain score during sessions reduced in the intervention group from the first to final session (-11.6, p = 0.053) but not for the placebo group (-4.2, p = 0.414). Seven serious adverse events were recorded, 4 in the intervention group and 3 in the placebo group, with 11 minor adverse events only in the intervention group (mostly shortness of breath). CONCLUSION: Nitrous oxide gas associated with intensive physiotherapy for shoulder adhesive capsulitis did not improve function, pain or quality of life more than physiotherapy alone. zHowever, pain experienced during physiotherapy sessions appeared lower. TRIAL REGISTRATION: Clinical Trial registration number NCT01087229.

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.