Shockwave Dose for Adhesive Capsulitis

NCT ID: NCT07325318

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2021-12-31

Brief Summary

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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

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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

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Adhesive Capsulitis, Shoulder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

two different shockwave doses are performed to treat adhesive capsulitis
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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extracoporeal sockwave therapy basic dose

3,000 pulses of shockwave per session as the basic treatment

Group Type EXPERIMENTAL

focused extracoporeal sockwave

Intervention Type DEVICE

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.

extracoporeal shockwave therapy high dose

6,000 pulses of shockwave per session as the high dose treatment

Group Type EXPERIMENTAL

focused extracoporeal sockwave

Intervention Type DEVICE

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.

Interventions

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focused extracoporeal sockwave

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital Hsin-Chu Branch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type BACKGROUND
PMID: 27664561 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32553435 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14625334 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32309425 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15334439 (View on PubMed)

Related Links

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https://www.richard-wolf.com/en/disciplines/shockwaves/piezowave2

The website describes the shockwave device used in the study as well as the underlying treatment principles.

Other Identifiers

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108-124-E

Identifier Type: -

Identifier Source: org_study_id

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