- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07325318
Shockwave Dose for Adhesive Capsulitis
January 7, 2026 updated by: National Taiwan University Hospital Hsin-Chu Branch
Study on the Dose of Extracorporeal Shockwave Therapy for Treating Adhesive Capsulitis
The investigators evaluated the therapeutic efficacy of different shockwave dosages for adhesive capsulitis and further examined the temporal effects and subgroup responses based on baseline range of motion
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study compares two different shockwave treatment doses, each delivered as a single session to patients with adhesive capsulitis of the shoulder.
We will measure shoulder range of motion before and after treatment and assess functional improvement using the Constant-Murley score.
Finally, we will analyze changes in joint mobility at various post-treatment time intervals to evaluate the therapeutic effectiveness of the two shockwave dosing protocols.
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Hsinchu, Taiwan, 300195
- National Taiwan University Hospital Hsin-Chu Branch
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- patient age ≥ 20 years
- first episode of adhesive capsulitis
- persistent shoulder pain with restricted motion for ≥ 3 months
- prior management limited to analgesic medications
- active abduction in the scapular plane ≤ 135°
Exclusion Criteria:
- shoulder or cervical pathology
- history of shoulder fracture, infection, or tumor
- previous shoulder surgery
- pacemaker presence
- pregnancy
- coagulopathy
- inability to complete follow-up assessments
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: extracoporeal sockwave therapy basic dose
3,000 pulses of shockwave per session as the basic treatment
|
Focused ESWT energy was initiated at level 5 (0.034 mJ/mm²) with a 4-Hz frequency and subsequently adjusted based on patient tolerance.
After the application of coupling gel, different pulses were applied one fingerbreadth inferior to the anterior acromion, lateral to the acromion, and posterior to the acromion.
|
|
Experimental: extracoporeal shockwave therapy high dose
6,000 pulses of shockwave per session as the high dose treatment
|
Focused ESWT energy was initiated at level 5 (0.034 mJ/mm²) with a 4-Hz frequency and subsequently adjusted based on patient tolerance.
After the application of coupling gel, different pulses were applied one fingerbreadth inferior to the anterior acromion, lateral to the acromion, and posterior to the acromion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
We assessed changes in shoulder range of motion using a standard goniometer before and after treatment with varying shockwave dosages
Time Frame: Before treatment, immediately after treatment, and at 1, 2, 4, 8, and 12 weeks post-treatment
|
In patients receiving different doses of extracorporeal shockwave therapy for adhesive capsulitis, we assessed changes in shoulder range of motion before and after treatment using a standard goniometer.
We will assess forward flexion, abduction, external rotation, and internal rotation.
The better the range of motion, the better the treatment outcome.
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Before treatment, immediately after treatment, and at 1, 2, 4, 8, and 12 weeks post-treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
We assessed changes in shoulder functional outcomes using the Constant-Murley questionnaire before and after treatment with varying shockwave dosages
Time Frame: before treatment and 12 weeks posttreatment
|
In patients receiving different doses of extracorporeal shockwave therapy for adhesive capsulitis, we evaluated changes in shoulder function by administering the Constant-Murley questionnaire both before and after treatment.
The questionnaire includes four subcategories: pain score (maximum 15 points), activities of daily living (maximum 20 points), movement (maximum 40 points), and strength (maximum 25 points).
The Constant-Murley Score has a maximum of 100 points, with higher scores indicating a better outcome."
|
before treatment and 12 weeks posttreatment
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The impact of changes over time before and after shockwave therapy on joint angle improvement
Time Frame: immediately after treatment and 1, 2, 4, 8, and 12 weeks posttreatment
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We analyzed the magnitude of joint angle changes at multiple time points to compare the therapeutic effects of the various shockwaves doses.
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immediately after treatment and 1, 2, 4, 8, and 12 weeks posttreatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Walker-Bone K, Palmer KT, Reading I, Coggon D, Cooper C. Prevalence and impact of musculoskeletal disorders of the upper limb in the general population. Arthritis Rheum. 2004 Aug 15;51(4):642-51. doi: 10.1002/art.20535.
- 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.
- Gerdesmeyer L, Wagenpfeil S, Haake M, Maier M, Loew M, Wortler K, Lampe R, Seil R, Handle G, Gassel S, Rompe JD. Extracorporeal shock wave therapy for the treatment of chronic calcifying tendonitis of the rotator cuff: a randomized controlled trial. JAMA. 2003 Nov 19;290(19):2573-80. doi: 10.1001/jama.290.19.2573.
- Wang CJ, Huang CC, Yip HK, Yang YJ. Dosage effects of extracorporeal shockwave therapy in early hip necrosis. Int J Surg. 2016 Nov;35:179-186. doi: 10.1016/j.ijsu.2016.09.013. Epub 2016 Sep 21.
- Yao G, Chen J, Duan Y, Chen X. Efficacy of Extracorporeal Shock Wave Therapy for Lateral Epicondylitis: A Systematic Review and Meta-Analysis. Biomed Res Int. 2020 Mar 18;2020:2064781. doi: 10.1155/2020/2064781. eCollection 2020.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2021
Primary Completion (Actual)
December 31, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
November 24, 2025
First Submitted That Met QC Criteria
January 7, 2026
First Posted (Actual)
January 8, 2026
Study Record Updates
Last Update Posted (Actual)
January 8, 2026
Last Update Submitted That Met QC Criteria
January 7, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 108-124-E
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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