Actively Recruiting

Phase Not Applicable
Age: 20Years - 80Years
All Genders
ID06491745

Is Adding Extracorporeal Shock Wave Therapy to Physiotherapy and Corticosteroid Injection Beneficial for Frozen Shoulder?

Led by Shin Kong Wu Ho-Su Memorial Hospital · Updated on 2025-12-30

94

Participants Needed

1

Research Sites

126 weeks

Total Duration

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AI-Summary

What this Trial Is About

Frozen shoulder, also known as adhesive capsulitis, is a common condition involving pain and limited movement in the shoulder joint, which can lead to difficulties in daily activities and reduced quality of life. It can occur without an obvious cause or be related to medical issues such as injury, inflammation, or diabetes. This trial aims to explore whether adding extracorporeal shock wave therapy (ESWT) to standard treatments can provide additional benefits for those with frozen shoulder, as this effect has not yet been fully established. Participants will be randomly assigned to one of two groups: the ESWT group or the sham ESWT group. Both groups will receive two corticosteroid injections into the shoulder joint and subdeltoid bursa, spaced two weeks apart, along with an 8-week physical therapy program. The ESWT group will receive four weekly sessions of active ESWT, while the sham group will receive four weekly sessions of minimal energy ESWT to maintain blinding. Throughout the study, participants will be assessed for pain levels, shoulder function, and range of motion at the start and at 1, 2, 4, and 6 months after treatment begins. Evaluations will also include questionnaires about disability and overall health. These assessments will help determine the impact of adding ESWT on shoulder pain and disability, monitored carefully by researchers until the study's completion at six months.

CONDITIONS

Brief Title

Is Adding Extracorporeal Shock Wave Therapy to Physiotherapy and Corticosteroid Injection Beneficial for Frozen Shoulder

Who Can Participate

Age: 20Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 20 to 80 years old
  • Shoulder pain lasting at least 1 month
  • More than 30% loss of passive range of motion in external rotation and/or abduction compared to the other shoulder
  • Pain score greater than 4 on maximal passive external rotation or abduction
  • Willing to receive extracorporeal shock wave therapy, shoulder joint injection, and attend regular physical therapy programs for 8 weeks
Not Eligible

You will not qualify if you...

  • Severe systemic disorders including cancer, stroke, or cardiopulmonary diseases
  • Uncontrolled diabetes mellitus
  • Rotator cuff tear or calcification of the affected shoulder
  • Fracture, dislocation, or arthritis of the shoulder due to rheumatic disorders
  • History of drug allergy to local anesthetics or corticosteroids
  • Pregnancy
  • Receiving extracorporeal shock wave therapy or corticosteroid injection in the affected shoulder within the past three months

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 8 weeks

Participants receive extracorporeal shock wave therapy or sham treatment weekly for 4 weeks, 2 corticosteroid injections at 2-week intervals, and an 8-week physical therapy program for frozen shoulder.

4 weekly visits for shock wave therapy or sham treatment, 2 visits for corticosteroid injections, and regular physical therapy sessions over 8 weeks

Follow-up

Duration - 6 months

Participants are evaluated for changes in pain and shoulder function at 1, 2, 4, and 6 months after the beginning of treatment.

4 follow-up visits at 1, 2, 4, and 6 months

Trial Site Locations

Total: 1 location

1

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

Actively Recruiting

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Research Team

L

Lin-Fen Hsieh

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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