NCT07325318

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

12 months

First QC Date

November 24, 2025

Last Update Submit

January 7, 2026

Conditions

Keywords

Adhesive capsulitisRange of motionExtracorporeal shockwave therapy

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    before treatment and 12 weeks posttreatment

  • The impact of changes over time before and after shockwave therapy on joint angle improvement

    immediately after treatment and 1, 2, 4, 8, and 12 weeks posttreatment

Study Arms (2)

extracoporeal sockwave therapy basic dose

EXPERIMENTAL

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

Device: focused extracoporeal sockwave

extracoporeal shockwave therapy high dose

EXPERIMENTAL

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

Device: focused extracoporeal sockwave

Interventions

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 doseextracoporeal sockwave therapy basic dose

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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°

You may not qualify if:

  • shoulder or cervical pathology
  • history of shoulder fracture, infection, or tumor
  • previous shoulder surgery
  • pacemaker presence
  • pregnancy
  • coagulopathy
  • inability to complete follow-up assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, 300195, Taiwan

Location

Related Publications (5)

  • 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.

    PMID: 27664561BACKGROUND
  • 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.

    PMID: 32553435BACKGROUND
  • 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.

    PMID: 14625334BACKGROUND
  • 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.

    PMID: 32309425BACKGROUND
  • 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.

    PMID: 15334439BACKGROUND

Related Links

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: two different shockwave doses are performed to treat adhesive capsulitis
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2025

First Posted

January 8, 2026

Study Start

January 1, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

January 8, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations