Initial effect of high-volume mobilisation with movement on shoulder range of motion and pain in patients with rotator cuff-related shoulder pain: protocol for a randomised controlled trial (Evolution Trial)

Abstract

IntroductionMobilisation with movement (MWM) is commonly used for treating patients with rotator cuff-related shoulder pain (RCRSP). However, the evidence supporting MWM efficacy for improving shoulder range of motion (ROM) and pain in patients with RCRSP is limited. It is also unclear whether higher volume MWM leads to better clinical outcomes compared with lower volume MWM in patients with RCRSP. The primary aim of this study is to assess the effect of MWM on the angular onset of pain during shoulder abduction in patients with RCRSP.Methods and analysisSixty participants with RCRSP will be randomised to receive either MWM or sham MWM intervention. The primary outcome is the angular onset of pain during shoulder abduction, and secondary outcomes are pain intensity at the angular onset of pain during shoulder abduction, maximum shoulder ROM, pain intensity during maximum shoulder abduction, pressure pain threshold, mechanical temporal summation, global rating of change scale (GROC) and Brief Pain Inventory-Short Form (BPI-SF). The angular onset of pain and the pain intensity at that range will be assessed at baseline, after 1 set and 3 sets of 10 repetitions of MWM or sham MWM. The GROC will be measured immediately after receiving 3 sets of interventions and on day 3 after interventions. The BPI-SF will be measured on days 1, 3, 5 and 7 after interventions. Other secondary outcomes will be assessed at baseline and after 3 sets of interventions. A linear mixed effects model with a random intercept will be used to compare changes in the outcome measures between MWM and sham MWM interventions.Ethics and disseminationThis study has been approved by the University of Otago Ethics Committee (Ref. H21/117). Findings from this study will be disseminated through presentations at international and national conferences and will be submitted for publication in a peer-reviewed journal.Trial registration numberACTRN 12621001723875.

Test-retest reliability of movement-evoked pain and sensitivity to movement-evoked pain in patients with rotator cuff-related shoulder pain

“…This test-retest reliability study was conducted within a randomized controlled trial which explored the initial effects of mobilization with movement on shoulder ROM and pain in patients with RCRSP (registration number: ACTRN 12621001723875). 23 We conducted the test-retest reliability study on the confirmative screening day of participants’ recruitment and before participants received any intervention from the randomized controlled trial. We reported this test-retest reliability study as per the guidelines for reporting reliability and agreement studies (GRRAS).…”

“…The COnsensus-based Standards for the Selection of health Measurement INstruments (COSMIN) recommends a minimum of 50 participants when conducting a reliability study. 25 This study was conducted as part of a randomised controlled trial, 23 involving the recruitment of seventy-four participants.…”