Status:
RECRUITING
Comparing HILT, Steroid Injection, and Manual Therapy for Frozen Shoulder
Lead Sponsor:
Al Hayah University In Cairo
Conditions:
Frozen Shoulder
Eligibility:
All Genders
40-70 years
Phase:
NA
Brief Summary
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 j...
Eligibility Criteria
Inclusion
- Age between 40 and 70 years, inclusive. Clinical diagnosis of primary (idiopathic) frozen shoulder, defined by shoulder pain and ≥50% restriction in passive external rotation compared to the contralateral (unaffected) shoulder.
- Symptom duration between 3 and 9 months. Average shoulder pain intensity ≥ 4 on a 10-cm Visual Analogue Scale (VAS) over the past week.
- Normal or age-appropriate radiographic findings of the glenohumeral joint (ruling out significant arthritis, fractures, calcific tendinitis).
- Willingness and ability to attend scheduled treatment/assessment sessions. Ability to understand study procedures and provide written informed consent.
Exclusion
- Secondary frozen shoulder (e.g., post-traumatic, post-surgical, related to systemic disease like diabetes - clarify if diabetes is excluded or just secondary FS from diabetes).
- Clinical or imaging evidence of significant rotator cuff tear requiring specific management.
- Radiographic evidence of moderate to severe glenohumeral osteoarthritis (e.g., Kellgren-Lawrence grade ≥ 3).
- Previous surgery on the index shoulder. Significant neurological disorders affecting shoulder or upper extremity function (e.g., cervical radiculopathy, stroke).
- Received a corticosteroid injection in the index shoulder within the past 3 months.
- Known contraindications to corticosteroid injections (e.g., uncontrolled diabetes, allergy, local infection).
- Known contraindications to High-Intensity Laser Therapy (e.g., active malignancy in the treatment area, photosensitivity, pacemaker over treatment area).
- Current participation in another interventional clinical trial for shoulder pain.
Key Trial Info
Start Date :
April 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06916650
Start Date
April 25 2025
End Date
August 1 2027
Last Update
April 8 2025
Active Locations (1)
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1
Faculty of Physical Therapy, Al Hayah University
Cairo, Egypt, 12311