Shockwave Dose for Adhesive Capsulitis

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

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

      • Hsinchu, Taiwan, 300195
        • National Taiwan University Hospital Hsin-Chu Branch

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.
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
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
We analyzed the magnitude of joint angle changes at multiple time points to compare the therapeutic effects of the various shockwaves doses.
immediately after treatment and 1, 2, 4, 8, and 12 weeks posttreatment

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.

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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