An interventional study of Shock wave therapy in Shoulder Pain and Adhesive Capsulitis of Shoulder, sponsored by University of Stirling. Not yet recruiting. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-27.
Sponsored by University of Stirling · Not applicable, Interventional, and Treatment
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.
Shoulder AC, commonly known as frozen shoulder, is a self-limiting condition that affects three to five percent of the population and up to 20 to 30 percent in persons with diabetes mellitus. Its aetiology is still being understood with evidence supporting a chronic state of low-grade inflammation and elevation of pro-inflammatory lipoproteins resulting in fibrotic changes in the glenohumeral capsule. This results in pain, reduced shoulder range of movement (ROM) and functional disability that can spontaneously resolve between one to three years, with 40 percent reporting persistent symptoms at long-term follow up (mean follow up time 4.4 years, range 2 - 20 years). AC can occur spontaneously, as a primary insidious onset, or secondary, following a post-traumatic event such as shoulder surgery or rotator cuff injury. Treatment for AC commonly consists of conservative management interventions including pharmacotherapy, physiotherapy, and corticosteroid injection, with referral to secondary care if symptoms persist for interventions such as manipulation under anaesthesia and arthroscopic capsular release.
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.
735 studies on the registry are indexed under Shoulder Pain; 167 are open to participants now.
This study's planned enrollment of 18 is below the median of 60 across 587 interventional studies indexed under Shoulder Pain.
Browse Shoulder Pain studies →University of Stirling is the lead sponsor of 23 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
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.
Radial Extracorporeal Shock Wave Therapy and feasibility as treatment for adhesive capsulitis
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
Time frame: 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
Time frame: 18 month
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.
Time frame: 0, 6, 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.
Time frame: 0, 6, 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.
Time frame: 0, 6, and 12 weeks.
Digital Goniometry
A digital goniometer or smart phone application digital inclinometer will be used to measure shoulder joint passive ROM.
Time frame: 0, 6, and 12 weeks.
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Stirling