Adhesive Capsulitis, ShoulderNCT07325318
Shockwave Dose for Adhesive Capsulitis
A study testing focused extracoporeal sockwave in people with Adhesive Capsulitis, Shoulder, run by National Taiwan University Hospital Hsin-Chu Branch at 1 site in Taiwan.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Adhesive Capsulitis, Shoulder
- What is being tested?
- focused extracoporeal sockwave
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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°
Who cannot join
- shoulder or cervical pathology
- history of shoulder fracture, infection, or tumor
- previous shoulder surgery
- pacemaker presence
- pregnancy
- coagulopathy
- inability to complete follow-up assessments
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital Hsin-Chu Branch
Hsinchu, 300195
About this study
Official title: 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
Read the 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.
- Conditions
- Adhesive Capsulitis, Shoulder
- Being tested
- focused extracoporeal sockwave
- Keywords
- Adhesive capsulitis, Range of motion, Extracorporeal shockwave therapy
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
focused extracoporeal sockwaveDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| extracoporeal sockwave therapy basic dose | Experimental | 3,000 pulses of shockwave per session as the basic treatment Receives: Device: focused extracoporeal sockwave |
| extracoporeal shockwave therapy high dose | Experimental | 6,000 pulses of shockwave per session as the high dose treatment Receives: Device: focused extracoporeal sockwave |
What is being measured
The primary outcome is the main question the study is designed to answer.
We assessed changes in shoulder range of motion using a standard goniometer before and after treatment with varying shockwave dosages
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.
Measured: Before treatment, immediately after treatment, and at 1, 2, 4, 8, and 12 weeks post-treatment
Secondary outcomes (2)
We assessed changes in shoulder functional outcomes using the Constant-Murley questionnaire before and after treatment with varying shockwave dosages
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."
Measured: before treatment and 12 weeks posttreatment
The impact of changes over time before and after shockwave therapy on joint angle improvement
We analyzed the magnitude of joint angle changes at multiple time points to compare the therapeutic effects of the various shockwaves doses.
Measured: immediately after treatment and 1, 2, 4, 8, and 12 weeks posttreatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start1 Jan 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Adhesive Capsulitis, ShoulderStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- two different shockwave doses are performed to treat adhesive capsulitis
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu Branch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07325318
- Sponsor's protocol ID
- 108-124-E
- Status last verified
- Jan 2026
- First submitted
- 24 Nov 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27664561El 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 32553435Gerdesmeyer 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.
PubMed 14625334Yao 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.
PubMed 32309425Walker-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.
PubMed 15334439
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Dose of Extracorporeal Shockwave Therapy for Treating Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT07325318
- Acronym / sponsor ID
- 108-124-E
- Conditions
- Adhesive Capsulitis, Shoulder
- Keywords
- Adhesive capsulitis, Range of motion, Extracorporeal shockwave therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu BranchUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 8 Jan 2026 (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.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- two different shockwave doses are performed to treat adhesive capsulitis
| Arm | Type | Receives |
|---|---|---|
| extracoporeal sockwave therapy basic dose | Experimental | Device: focused extracoporeal sockwave3,000 pulses of shockwave per session as the basic treatment |
| extracoporeal shockwave therapy high dose | Experimental | Device: focused extracoporeal sockwave6,000 pulses of shockwave per session as the high dose treatment |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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°
Key exclusion criteria (7 listed)
- shoulder or cervical pathology
- history of shoulder fracture, infection, or tumor
- previous shoulder surgery
- pacemaker presence
- pregnancy
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 |
|---|---|---|
| focused extracoporeal sockwaveFocused 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. | Device | extracoporeal shockwave therapy high dose, extracoporeal sockwave therapy basic dose |
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Background: PubMed 27664561Wang 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.
- Background: PubMed 32553435El 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.
- Background: PubMed 14625334Gerdesmeyer 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.
- Background: PubMed 32309425Yao 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.
- Background: PubMed 15334439Walker-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.
- The website describes the shockwave device used in the study as well as the underlying treatment principles.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing focused extracoporeal sockwave in people with Adhesive Capsulitis, Shoulder, run by National Taiwan University Hospital Hsin-Chu Branch at 1 site in Taiwan.
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 7 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: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 NCT07325318, which also lists 5 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 8 Jan 2026.