Shock Wave Therapy as a Treatment Intervention for Frozen Shoulder

NCT06490172 | Not Yet Recruiting DMC

• 1 other identifier: 18192
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Shoulder Pain; Adhesive Capsulitis of Shoulder

Keywords

shock wave therapy; frozen shoulder; adhesive capsulitis; shoulder pain; physiotherapy; lithotripsy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• The Shoulder Pain and Disability Index

  0, 6, and 12 weeks.

• Numerical Pain Rating Scale

  0, 6, and 12 weeks.

• EuroQoL-5D-5L

  0, 6, and 12 weeks.

• Digital Goniometry

  0, 6, and 12 weeks.

Study Arms (3)

Delphi Study

NO INTERVENTION

The survey will be re-circulated a minimum of three, and maximum of four rounds, with an aim for a minimum of 20 participants and response rate of greater than 70 percent per round. The results will be collected and collated at each round to determine a consensus amongst shoulder specialists for further review. This information will be used to guide the treatment protocol in phase two.

Shock wave therapy quantitative data collection and analysis

EXPERIMENTAL

This phase will involve the piloting of the shock wave therapy protocol determined by the results collected in phase one Delphi study Following participant consent, the research healthcare practitioner will provide patient reported outcome measure questionnaires for the participant to complete independently to measure baseline data. This will occur at baseline, 6 and 12 weeks following shock wave therapy treatment.

Device: Shock wave therapy

Qualitative semi-structured interviews

NO INTERVENTION

All participants in phase 2 and those who declined participation in the quantitative study at the recruitment stage will be invited to take part in semi-structured qualitative interviews of a duration of 30 - 45 minutes. The interview protocol and questions will be developed based on the findings of the quantitative data analysis. Interviews will take place approximately 12 weeks from last ESWT treatment.

Interventions

Shock wave therapy DEVICE

Radial Extracorporeal Shock Wave Therapy and feasibility as treatment for adhesive capsulitis

Shock wave therapy quantitative data collection and analysis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants aged 18 years and older.
• Diagnosis of primary or secondary shoulder AC of a greater than three-month duration.
• Diagnosis of AC by an orthopaedic consultant or upper limb Advanced Practice Physiotherapist.
• Participants can attend an outpatient rural physiotherapy department to receive shockwave therapy intervention.
• They understand English.

You may not qualify if:

• Participants who have bilateral shoulder pain, capsular tightness, calcific rotator cuff tendinitis, rotator cuff tear (atraumatic or traumatic), previous surgery on the affected shoulder, shoulder fracture, dislocation or subluxation, glenohumeral or acromioclavicular arthritis, malignancy, inflammatory disorders, neuromuscular disorders, presence of severe osteoporosis, pulmonary diseases, implanted pacemaker and pregnancy.
• They have conditions related to ESWT contraindications (e.g., pregnancy, pacemaker, metal work or joint replacement near the treatment site, blood clotting disorder, use of anti-coagulants, less than six weeks of receiving a steroid injection over treatment site, malignancy, local infection or open wounds, skeletal growth places, under 18 years old).
• Symptom duration less than 12 weeks.
• Absent or altered skin sensation.
• They are unable to give full informed consent.

Sponsors & Collaborators

• University of Stirling: lead

Related Publications (29)

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MeSH Terms

Conditions

Shoulder Pain; Bursitis

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Crystal Reno

  University of Stirling

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Crystal Reno, MSc, DPT

CONTACT

+44 1786 466340; c.a.reno@stir.ac.uk

University of Stirling

CONTACT

+44 1786 466340

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professional Clinical Doctorate Student

Model Details: Mixed Methods Explanatory Sequential Design

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: July 8, 2024
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share