Clinical trial Recruiting at 1 site Interventional Ages 40 to 70

Comparing treatments for frozen shoulder

Official title: 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

Run by Al Hayah University In Cairo · NCT06916650 · Data updated 2026-11-12

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

Study typeInterventional
Ages40 Years to 70 Years
SexAll
Enrollment180 (estimated)
SponsorAl Hayah University In Cairo
Academic / other
Locations1 site (Cairo)
StatusRecruiting
StartedApril 25, 2025
Main results expectedMay 1, 2027
Study endsAugust 1, 2027
Registry record updatedApril 8, 2025
Trial IDNCT06916650 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

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

Probably not a fit

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

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.