Comparing treatments for frozen shoulder

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

This study is testing which of three treatments for frozen shoulder—High-Intensity Laser Therapy, corticosteroid injections, or manual therapy—works best when combined with exercise to help reduce pain and improve shoulder movement.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 40 Years to 70 Years
• Sex: All
• Sponsor: Al Hayah University In Cairo (Academic / other)
• Locations: 1 site (Cairo)
• Trial ID: NCT06916650 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of three treatments for frozen shoulder when combined with a standard exercise program: High-Intensity Laser Therapy (HILT), corticosteroid injections, and manual therapy by a physical therapist. Participants will be divided into four groups, with one group receiving only the standard exercise program. The study aims to determine which treatment combination is most effective in reducing pain and improving shoulder function over a period of six months. The primary outcomes will be assessed using a Visual Analogue Scale for pain and the Shoulder Pain and Disability Index (SPADI) questionnaire at 12 weeks.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 40 to 70 with a clinical diagnosis of primary frozen shoulder and significant pain and mobility restrictions.

Not a fit: Patients with secondary frozen shoulder due to trauma, surgery, or systemic diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide patients with more effective treatment options for managing frozen shoulder.

How similar studies have performed: Other studies have shown varying degrees of success with similar treatment approaches for frozen shoulder, but this specific comparison is novel.

Eligibility criteria

Inclusion Criteria:

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 Criteria:

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.

Where this trial is running

Cairo

• Faculty of Physical Therapy, Al Hayah University — Cairo, Egypt (Recruiting)

Study contacts

• Study coordinator: Ibrahim Zoheiry, Ph.D

Conditions Frozen Shoulder