Actively Recruiting

Phase Not Applicable
Age: 40Years - 70Years
All Genders
NCT06916650

Comparing HILT, Steroid Injection, and Manual Therapy for Frozen Shoulder

Led by Al Hayah University In Cairo · Updated on 2025-04-08

180

Participants Needed

1

Research Sites

118 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study compares three common treatments for frozen shoulder when added to a standard exercise program: High-Intensity Laser Therapy (HILT), a corticosteroid (steroid) injection into the shoulder joint, and hands-on manual therapy by a physical therapist. A fourth group will receive only the standard exercise program. The goal is to see which combination works best to reduce shoulder pain and improve shoulder function over 6 months. The main outcomes are changes in pain (VAS scale) and shoulder disability (SPADI questionnaire) at 12 weeks.

CONDITIONS

Official Title

Comparing HILT, Steroid Injection, and Manual Therapy for Frozen Shoulder

Who Can Participate

Age: 40Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 40 and 70 years, inclusive
  • Clinical diagnosis of primary (idiopathic) frozen shoulder with 60% restriction in passive external rotation compared to the unaffected shoulder
  • Symptom duration between 3 and 9 months
  • Average shoulder pain intensity 6 4 on a 10-cm Visual Analogue Scale over the past week
  • Normal or age-appropriate shoulder X-rays ruling out significant arthritis, fractures, or calcific tendinitis
  • Willingness and ability to attend treatment and assessment sessions
  • Ability to understand study procedures and provide written informed consent
Not Eligible

You will not qualify if you...

  • Secondary frozen shoulder due to trauma, surgery, or systemic disease like diabetes
  • Significant rotator cuff tear needing specific treatment
  • Moderate to severe shoulder osteoarthritis visible on X-ray (grade 6 3)
  • Previous surgery on the affected shoulder
  • Major neurological disorders affecting shoulder or arm function
  • Corticosteroid injection in the affected shoulder within past 3 months
  • Known contraindications to corticosteroid injections such as uncontrolled diabetes, allergy, or local infection
  • Known contraindications to High-Intensity Laser Therapy such as active cancer in the treatment area, photosensitivity, or pacemaker in the area
  • Current participation in another clinical trial for shoulder pain

AI-Screening

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Trial Site Locations

Total: 1 location

1

Faculty of Physical Therapy, Al Hayah University

Cairo, Egypt, 12311

Actively Recruiting

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Research Team

I

Ibrahim Zoheiry, Ph.D

CONTACT

M

Mohamed ElMeligie, Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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