Shoulder PainNCT06490172
Shock Wave Therapy as a Treatment Intervention for Frozen Shoulder
A study testing Shock wave therapy in people with Shoulder Pain and Adhesive Capsulitis of Shoulder, run by University of Stirling.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Pain, Adhesive Capsulitis of Shoulder
- What is being tested?
- Shock wave therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
University of Stirling contact
About this study
Official title: The Effects of Extracorporeal Shock Wave Therapy as a Treatment Intervention for Chronic Adhesive Capsulitis: a Mixed Methods Pilot Study
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.
Read the detailed description
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.
- Conditions
- Shoulder Pain, Adhesive Capsulitis of Shoulder
- Being tested
- Shock wave therapy
- Keywords
- shock wave therapy, frozen shoulder, adhesive capsulitis, shoulder pain, physiotherapy, lithotripsy
- Medical subject headings
- Shoulder Pain, Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shock wave therapyDevice
Radial Extracorporeal Shock Wave Therapy and feasibility as treatment for adhesive capsulitis
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 18 month
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0, 6, and 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study startMay 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Mixed Methods Explanatory Sequential Design
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Stirling
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Crystal Reno, University of Stirling
- Investigators
- Crystal Reno, Principal investigator, University of Stirling
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490172
- Sponsor's protocol ID
- 18192
- Status last verified
- Jan 2026
- First submitted
- 11 Mar 2024
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zreik NH, Malik RA, Charalambous CP. Adhesive capsulitis of the shoulder and diabetes: a meta-analysis of prevalence. Muscles Ligaments Tendons J. 2016 May 19;6(1):26-34. doi: 10.11138/mltj/2016.6.1.026. eCollection 2016 Jan-Mar.
PubMed 27331029Le HV, Lee SJ, Nazarian A, Rodriguez EK. Adhesive capsulitis of the shoulder: review of pathophysiology and current clinical treatments. Shoulder Elbow. 2017 Apr;9(2):75-84. doi: 10.1177/1758573216676786. Epub 2016 Nov 7.
PubMed 28405218Kraal T, Lubbers J, van den Bekerom MPJ, Alessie J, van Kooyk Y, Eygendaal D, Koorevaar RCT. The puzzling pathophysiology of frozen shoulders - a scoping review. J Exp Orthop. 2020 Nov 18;7(1):91. doi: 10.1186/s40634-020-00307-w.
PubMed 33205235Hand C, Clipsham K, Rees JL, Carr AJ. Long-term outcome of frozen shoulder. J Shoulder Elbow Surg. 2008 Mar-Apr;17(2):231-6. doi: 10.1016/j.jse.2007.05.009. Epub 2007 Nov 12.
PubMed 17993282NICE (2017) Scenario: frozen shoulder. Available: https://cks.nice.org.uk/topics/shoulder-pain/management/frozen-shoulder/ [Accessed: 04 November 2022].
Dennis, L., Brealey, S., Rangan, A., Rookmoneea, M. and Watson, J. (2010) Managing idiopathic frozen shoulder: a survey of health professionals' current practice and research priorities. Shoulder and Elbow, 2 (4), pp. 294-300.
Smith G, D'Cruz JR, Goldman J. General Anesthesia for Surgeons. 2023 Aug 5. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK493199/
PubMed 29630251Wang CJ. Extracorporeal shockwave therapy in musculoskeletal disorders. J Orthop Surg Res. 2012 Mar 20;7:11. doi: 10.1186/1749-799X-7-11.
PubMed 22433113Taylor J, Dunkerley S, Silver D, Redfern A, Talbot N, Sharpe I, Guyver P. Extracorporeal shockwave therapy (ESWT) for refractory Achilles tendinopathy: A prospective audit with 2-year follow up. Foot (Edinb). 2016 Mar;26:23-9. doi: 10.1016/j.foot.2015.08.007. Epub 2015 Aug 31.
PubMed 26802946Lohrer H, Nauck T, Dorn-Lange NV, Scholl J, Vester JC. Comparison of radial versus focused extracorporeal shock waves in plantar fasciitis using functional measures. Foot Ankle Int. 2010 Jan;31(1):1-9. doi: 10.3113/FAI.2010.0001.
PubMed 20067715Waugh CM, Morrissey D, Jones E, Riley GP, Langberg H, Screen HR. In vivo biological response to extracorporeal shockwave therapy in human tendinopathy. Eur Cell Mater. 2015 May 15;29:268-80; discussion 280. doi: 10.22203/ecm.v029a20.
PubMed 25978115Chen CY, Hu CC, Weng PW, Huang YM, Chiang CJ, Chen CH, Tsuang YH, Yang RS, Sun JS, Cheng CK. Extracorporeal shockwave therapy improves short-term functional outcomes of shoulder adhesive capsulitis. J Shoulder Elbow Surg. 2014 Dec;23(12):1843-1851. doi: 10.1016/j.jse.2014.08.010.
PubMed 25441567El 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.
PubMed 32553435Hameedi, 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Extracorporeal Shock Wave Therapy as a Treatment Intervention for Chronic Adhesive Capsulitis: a Mixed Methods Pilot Study
- ClinicalTrials.gov ID
- NCT06490172
- Acronym / sponsor ID
- 18192
- Conditions
- Shoulder Pain, Adhesive Capsulitis of Shoulder
- Keywords
- shock wave therapy, frozen shoulder, adhesive capsulitis, shoulder pain, physiotherapy, lithotripsy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University of StirlingUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 8 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Mixed Methods Explanatory Sequential Design
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Shock wave therapyThis 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. |
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shock wave therapyRadial Extracorporeal Shock Wave Therapy and feasibility as treatment for adhesive capsulitis | Device | Shock wave therapy quantitative data collection and analysis |
Primary outcome
Recruitment and rejection rate
Time frame: 18 months
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
Retention rate
Time frame: 18 month
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
4 secondary outcomes
The Shoulder Pain and Disability Index
Time frame: 0, 6, and 12 weeks.
Numerical Pain Rating Scale
Time frame: 0, 6, and 12 weeks.
EuroQoL-5D-5L
Time frame: 0, 6, and 12 weeks.
Digital Goniometry
Time frame: 0, 6, and 12 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Background: PubMed 27331029Zreik NH, Malik RA, Charalambous CP. Adhesive capsulitis of the shoulder and diabetes: a meta-analysis of prevalence. Muscles Ligaments Tendons J. 2016 May 19;6(1):26-34. doi: 10.11138/mltj/2016.6.1.026. eCollection 2016 Jan-Mar.
- Background: PubMed 28405218Le HV, Lee SJ, Nazarian A, Rodriguez EK. Adhesive capsulitis of the shoulder: review of pathophysiology and current clinical treatments. Shoulder Elbow. 2017 Apr;9(2):75-84. doi: 10.1177/1758573216676786. Epub 2016 Nov 7.
- Background: PubMed 33205235Kraal T, Lubbers J, van den Bekerom MPJ, Alessie J, van Kooyk Y, Eygendaal D, Koorevaar RCT. The puzzling pathophysiology of frozen shoulders - a scoping review. J Exp Orthop. 2020 Nov 18;7(1):91. doi: 10.1186/s40634-020-00307-w.
- Background: PubMed 17993282Hand C, Clipsham K, Rees JL, Carr AJ. Long-term outcome of frozen shoulder. J Shoulder Elbow Surg. 2008 Mar-Apr;17(2):231-6. doi: 10.1016/j.jse.2007.05.009. Epub 2007 Nov 12.
- BackgroundNICE (2017) Scenario: frozen shoulder. Available: https://cks.nice.org.uk/topics/shoulder-pain/management/frozen-shoulder/ [Accessed: 04 November 2022].
- BackgroundDennis, L., Brealey, S., Rangan, A., Rookmoneea, M. and Watson, J. (2010) Managing idiopathic frozen shoulder: a survey of health professionals' current practice and research priorities. Shoulder and Elbow, 2 (4), pp. 294-300.
- Background: PubMed 29630251Smith G, D'Cruz JR, Goldman J. General Anesthesia for Surgeons. 2023 Aug 5. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK493199/
- Background: PubMed 22433113Wang CJ. Extracorporeal shockwave therapy in musculoskeletal disorders. J Orthop Surg Res. 2012 Mar 20;7:11. doi: 10.1186/1749-799X-7-11.
- Background: PubMed 26802946Taylor J, Dunkerley S, Silver D, Redfern A, Talbot N, Sharpe I, Guyver P. Extracorporeal shockwave therapy (ESWT) for refractory Achilles tendinopathy: A prospective audit with 2-year follow up. Foot (Edinb). 2016 Mar;26:23-9. doi: 10.1016/j.foot.2015.08.007. Epub 2015 Aug 31.
- Background: PubMed 20067715Lohrer H, Nauck T, Dorn-Lange NV, Scholl J, Vester JC. Comparison of radial versus focused extracorporeal shock waves in plantar fasciitis using functional measures. Foot Ankle Int. 2010 Jan;31(1):1-9. doi: 10.3113/FAI.2010.0001.
- Background: PubMed 25978115Waugh CM, Morrissey D, Jones E, Riley GP, Langberg H, Screen HR. In vivo biological response to extracorporeal shockwave therapy in human tendinopathy. Eur Cell Mater. 2015 May 15;29:268-80; discussion 280. doi: 10.22203/ecm.v029a20.
- Background: PubMed 25441567Chen CY, Hu CC, Weng PW, Huang YM, Chiang CJ, Chen CH, Tsuang YH, Yang RS, Sun JS, Cheng CK. Extracorporeal shockwave therapy improves short-term functional outcomes of shoulder adhesive capsulitis. J Shoulder Elbow Surg. 2014 Dec;23(12):1843-1851. doi: 10.1016/j.jse.2014.08.010.
- Individual participant dataSharing planned: No
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Subacromial Pain Syndrome
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Active, not recruiting
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
Not yet recruiting
Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain
Hemiplegic Shoulder Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
University of Stirling contact
Crystal Reno principal investigator
University of Stirling
Questions about this trial
What is this clinical trial studying?
A study testing Shock wave therapy in people with Shoulder Pain and Adhesive Capsulitis of Shoulder, run by University of Stirling.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Crystal Reno, MSc, DPT (+44 1786 466340, c.a.reno@stir.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment and rejection rate (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06490172, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.