Shock Wave Therapy as a Treatment Intervention for Frozen Shoulder
NCT Number: NCT06490172
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Shoulder Pain|Adhesive Capsulitis of Shoulder
Interventions: DEVICE: Shock wave therapy
Sponsor: University of Stirling
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2026-02

Summary:
Adhesive capsulitis (AC) is a debilitating condition that causes global restriction and pain at the glenohumeral joint. Physiotherapy treatment is often first line treatment management. Patients with failed conservative management are commonly referred to a specialist consultant for further treatment. Over the last 20 years, extracorporeal shock wave therapy (ESWT) has gained popularity as a treatment for various orthopaedic presentations, including chronic soft tissue conditions, being non-invasive, resulting in good outcomes with minimal side effects. There is a lack of evidence on the clinical effectiveness of ESWT for chronic AC following failed conservative treatments, with the available literature reporting positive outcomes, however, with heterogeneity in treatment protocols. This proposed study aims to explore the feasibility of a full trial of ESWT as a treatment for AC using a standardised treatment protocol, and clinical effects on outcomes of pain, function and shoulder joint range of movement in persons with chronic adhesive capsulitis.

A Delphi study will first explore expert opinion for the optimum treatment protocol of ESWT as a treatment for chronic AC, followed by a mixed methods explanatory sequential study that includes a pilot trial with nested qualitative interviews. The Shoulder Pain and Disability Index, numerical pain rating scale, EuroQol-5D, and digital goniometer will be used to measure self-reported pain and function, pain, health-related quality of life, and shoulder joint range of movement, respectively. Quantitative data will be analysed by descriptive statistics. Qualitative data will be collected through semi-structured interviews. Interview data will be analysed using Braun and Clarke's inductive thematic analysis approach. The study will be conducted in an out-patient clinical setting in a community health hub facility, with patients recruited from an NHS Orthopaedics waitlist. Data collection is planned over a nine month period. This study is not affiliated with funding streams.

Primary Outcome Measures: Recruitment and rejection rate, Estimate the proportion of patients screened who meet the eligibility criteria. This will be analysed with descriptive statistics using IBM SPSS Statistical Software. This will be displayed as a numerical value with standard deviation, 18 months|Retention rate, Adherence and compliance to intervention and home exercise programme, follow-up and drops out. This will be analysed with descriptive statistics using IBM SPSS Statistical Software. This will be displayed as a numerical value with standard deviation, 18 month
Secondary Outcome Measures: The Shoulder Pain and Disability Index, Self-reported pain and function in shoulder conditions. 13 item questionnaire that assesses two domains, pain and disability, that best represents their shoulder symptoms over a week. The scale is scored from a zero, 'no pain / no difficulty,' to 10, 'worst pain imaginable / so difficult requires help', with higher scores indicating increase impairment or disability, and can be used to monitor change over time. A difference of eight points is the minimal detectable change for clinical significance., 0, 4, 8, and 12 weeks.|Numerical Pain Rating Scale, One-dimensional tool used to measure pain both at rest and during movement. It is a 11-point scale for self-reported pain, zero meaning 'no pain' to 10 'extreme pain / worse pain possible,' at the time the questionnaire is administered and has been found to be more versatile being delivered in both verbal and written formats. Minimal clinical difference of change sore for general conditions is 3.0cm, and rotator cuff pain is 1.4cm on scale., 0, 4, 8, and 12 weeks.|EuroQoL-5D-5L, Questionnaire measuring health-related quality of life. It measures five dimensions of health, mobility, self-care, usual activities, pain and discomfort, and anxiety and depression, on a five-level scale. A score of one across all five categories represents the best possible health, whereas a score of five across all five categories represents the worst health status. The EQ-5D-5L also includes a perceived health status demonstrated as a visual analogue scale with grade ranging from zero, the worst possible health status, to 100, the best possible health status., 0, 4, 8, and 12 weeks.|Digital Goniometry, A digital goniometer or smart phone application digital inclinometer will be used to measure shoulder joint passive ROM., 0, 4, 8, and 12 weeks.