Actively Recruiting
Comparative Effectiveness of High-Intensity Laser Therapy Versus Corticosteroid Injection Versus Manual Therapy, Each Combined With Standard Exercise, for Frozen Shoulder (Adhesive Capsulitis): A Randomized Controlled Trial
Led by Al Hayah University In Cairo · Updated on 2025-04-08
180
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for frozen shoulder, also known as adhesive capsulitis, to find which combination reduces shoulder pain and improves function best over six months. The study compares High-Intensity Laser Therapy (HILT), corticosteroid injections, and manual therapy, each combined with a standard exercise program, as well as the exercise program alone. The main outcomes measured are changes in shoulder pain and disability at 12 weeks. Participants are assigned to one of four groups: one receives HILT twice weekly for six weeks plus the exercise program; another gets a single corticosteroid injection at the start plus exercises; a third group has manual therapy twice weekly for six weeks alongside exercises; and the last follows only the standard exercise program. The exercise program includes supervised sessions and daily home exercises over 12 weeks. During the study, participants attend regular treatment and assessment visits where their pain, shoulder movement, and overall change are measured at baseline, 6 weeks, 12 weeks, and 6 months. Researchers monitor any adverse events throughout the six-month participation period. This includes using scales for pain intensity and disability questionnaires to evaluate outcomes and track progress.
CONDITIONS
Brief Title
Comparing HILT, Steroid Injection, and Manual Therapy for Frozen Shoulder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 40 and 70 years, inclusive
- Clinical diagnosis of primary (idiopathic) frozen shoulder with shoulder pain and at least 50% restriction in passive external rotation compared to the unaffected shoulder
- Symptom duration between 3 and 9 months
- Average shoulder pain intensity of 4 or higher on a 10-cm Visual Analogue Scale over the past week
- Normal or age-appropriate shoulder X-rays without significant arthritis, fractures, or calcific tendinitis
- Willingness and ability to attend all treatment and assessment sessions
- Ability to understand study procedures and provide written informed consent
You will not qualify if you...
- Secondary frozen shoulder from trauma, surgery, or systemic diseases such as diabetes
- Significant rotator cuff tear requiring specific treatment
- Moderate to severe shoulder osteoarthritis seen on X-rays
- Previous surgery on the affected shoulder
- Significant neurological disorders affecting shoulder or arm function
- Corticosteroid injection in the affected shoulder within the past 3 months
- Contraindications to corticosteroid injections such as uncontrolled diabetes, allergy, or infection
- Contraindications to High-Intensity Laser Therapy such as active cancer in the area, photosensitivity, or pacemaker presence
- Current participation in another interventional clinical trial for shoulder pain
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive one of the following interventions combined with a Standard Exercise Program: High-Intensity Laser Therapy (HILT) twice a week for 6 weeks, a single ultrasound-guided corticosteroid injection at baseline, manual therapy twice a week for 6 weeks, or the Standard Exercise Program alone. The Standard Exercise Program includes supervised sessions twice a week for 6 weeks followed by once a week for 6 weeks, plus daily home exercises.
2 visits per week for 6 weeks for HILT or Manual Therapy sessions, 1 baseline visit for corticosteroid injection, and supervised exercise sessions twice weekly for 6 weeks then weekly for 6 weeks
Duration - Up to 6 months
Participants are assessed for changes in shoulder pain, disability, range of motion, and overall improvement up to 6 months after treatment completion. Adverse events are monitored throughout this period.
3 follow-up visits at 6 weeks, 12 weeks, and 6 months
Trial Site Locations
Total: 1 location
1
Faculty of Physical Therapy, Al Hayah University
Cairo, Egypt, 12311
Actively Recruiting
Research Team
I
Ibrahim Zoheiry, Ph.D
M
Mohamed ElMeligie, Ph.D
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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