Shock Wave Therapy as a Treatment Intervention for Frozen Shoulder
NCT ID: NCT06490172
Last Updated: 2024-12-12
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
18 participants
INTERVENTIONAL
2025-05-31
2026-03-31
Brief Summary
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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.
Detailed Description
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The treatment interventions or surgical procedures for AC may not always be effective or suitable for all patients due to conditions that may increase risk of complications such as respiratory conditions, allergies, previous surgery complications, co-morbidities (e.g., liver, cardiovascular and kidney disease), and patient choice. Untreated conditions and long-wait times can lead to chronicity further impacting an individual's health and increasing costs to the National Health Service (NHS). Musculoskeletal (MSK) conditions are estimated to cost to the British government an estimated £7 billion per year, accounting for one third of the NHS budget. In a United Kingdom (UK) health survey evaluating the prevalence of chronic pain (duration of pain 12 weeks or more), labelled MSK conditions as a long-lasting illness, accounting for 81 percent of participants, and of this, 24 percent involving the shoulder. Chronic MSK pain has also been linked to 17.5 percent of work absences, anxiety, depression, and health inequalities.
Over the last 20 years, EWST, has gained popularity as a treatment modality for orthopaedics conditions such as chronic tendinopathies. EWST can be generated as focused high- energy (\>0.60 millijoules (mj)/mm2) shock waves or emitted as radial low (\<0.08 mJ/mm2) to medium-energy (\<0.28 mJ/mm2) shock waves. ESWT stimulates soft tissue healing via a biological response of mechanotransduction through neovascularisation, reduction of tendon matrix inflammatory markers such as metalloproteinases and interleukins, assists with the migration and differentiation of mesenchymal stem cells, and enhances the natural healing microenvironment. To date, therapeutic EWST has been shown to be clinically effective to treat bone non-unions, chronic soft tissue disorders such as tendinopathies and recalcitrant MSK conditions commonly involving the supraspinatus muscle tendon, patellar tendon, Achilles tendon and plantar fascia, and has become a favourable alternative treatment for individuals who have exhausted conventional conservative interventions.
A review of the literature exploring the use of ESWT as a treatment for chronic AC found seven randomised control trials (RCT) reporting significant improvements in function, pain and shoulder ROM in groups that received ESWT. The literature found improvements in all outcomes within 12 weeks when compared to a control group.
Although the literature demonstrates positive outcomes, due to the small number of studies, small sample sizes, and heterogeneity of treatment protocols, there is insufficient evidence for it to be a recommended treatment for AC by national health guidelines (e.g., National Institute for Health and Care Excellence). Further research is therefore required to determine the acceptability and viability of this intervention in the UK healthcare framework, with potential to conduct a full-scale RCT.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Delphi Study
The survey will be re-circulated a minimum of three, and maximum of four rounds, with an aim for a minimum of 30 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.
No interventions assigned to this group
Shock wave therapy quantitative data collection and analysis
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.
Shock wave therapy
Radial Extracorporeal Shock Wave Therapy and feasibility as treatment for adhesive capsulitis
Qualitative semi-structured interviews
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.
No interventions assigned to this group
Interventions
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Shock wave therapy
Radial Extracorporeal Shock Wave Therapy and feasibility as treatment for adhesive capsulitis
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of primary or secondary shoulder AC of a greater than three-month duration.
3. Diagnosis of AC by an orthopaedic consultant or upper limb Advanced Practice Physiotherapist.
4. Participants can attend an outpatient rural physiotherapy department to receive shockwave therapy intervention.
5. They understand English.
Exclusion Criteria
2. 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).
3. Symptom duration less than 12 weeks.
4. Absent or altered skin sensation.
5. They are unable to give full informed consent.
18 Years
70 Years
ALL
Yes
Sponsors
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University of Stirling
OTHER
Responsible Party
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Crystal Reno
Professional Clinical Doctorate Student
Principal Investigators
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Crystal Reno
Role: PRINCIPAL_INVESTIGATOR
University of Stirling
Central Contacts
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University of Stirling
Role: CONTACT
Phone: +44 1786 466340
References
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El Naggar TEDM, Maaty AIE, Mohamed AE. Effectiveness of radial extracorporeal shock-wave therapy versus ultrasound-guided low-dose intra-articular steroid injection in improving shoulder pain, function, and range of motion in diabetic patients with shoulder adhesive capsulitis. J Shoulder Elbow Surg. 2020 Jul;29(7):1300-1309. doi: 10.1016/j.jse.2020.03.005.
Hameedi, I.A., Shadmehr, A., Malmir, K., Fereydounnia, S. and Shiravi, Z. (2022) Comparison of application of the radial vs. focused probes of extracorporeal shockwave therapy on pain, range of motion and function in patients with adhesive capsulitis. NeuroQuantology, 20 (6), pp. 2726.
Hussein, A.Z. and Donatelli, R.A. (2016) The efficacy of radial extracorporeal shockwave therapy in shoulder adhesive capsulitis: a prospective, randomised, double-blind, placebo-controlled, clinical study. European Journal of Physiotherapy, 18 (1), pp. 63-76.
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Other Identifiers
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18192
Identifier Type: -
Identifier Source: org_study_id