Effectiveness of shoulder symptom modification approaches in managing patients with frozen shoulder: study protocol for a randomized sham-controlled trial

BACKGROUND: Symptom modification approaches in musculoskeletal physiotherapy practice reduce pain and enhance movement. In our study two symptom modification approaches, shoulder symptom modification procedure (SSMP) and mobilization with movement (MWM) along with sham mobilization are compared. This study aimed to compare the effectiveness of the above approaches in managing pain and shoulder disability and improving shoulder movement in patients with frozen shoulder. METHODS: A total of 36 patients with frozen shoulder, will be randomly allocated for 8 weeks into three groups: (a) the SSMP group (n = 12) (b) the mobilization with movement (MWM) group(n = 12) and (c) sham mobilization group (n = 12). Patients with frozen shoulder aged 40-65 and meeting the inclusion criteria will be eligible. Each group will receive 3 sessions in a week for 8 weeks along with different exercises including isometric, eccentric and concentric followed by the functional program. Measurements will occur at four time points: before the initiation of treatment sessions (week 0), followed by 12 treatment sessions (week 4), then 18 treatment sessions (week 6) and two months from the beginning of the trial (week 8). The primary outcome was functional disability (SPADI). Secondary outcomes included pain intensity (NPRS), active shoulder range of motion (ROM), and the Patient Global Impression of Change (PGIC). DISCUSSION: This pilot study is the first to examine the effectiveness of symptom-modification approaches in patients with frozen shoulder. The study aims to provide preliminary data on feasibility, safety, and early clinical outcomes, as well as to document challenges encountered during implementation. Findings from this investigation will inform the design, methodology, and sample size estimation for a future large-scale randomized controlled trial assessing the efficacy of symptom-modification interventions in this population. TRIAL REGISTRATION: Clinical Trials.gov NCT06763601. Registered on 12/11/2024. URL of trial registry record: https://register. CLINICALTRIALS: gov/prs/beta/studies/S000F7NU00000067/recordSummary.