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Search / Trial NCT06916650

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

Launched by AL HAYAH UNIVERSITY IN CAIRO · Apr 1, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at three different treatments for frozen shoulder, a condition that causes pain and stiffness in the shoulder. The treatments being compared are High-Intensity Laser Therapy (HILT), a corticosteroid injection (a type of medicine that helps reduce inflammation), and manual therapy (hands-on treatment by a physical therapist). Participants will also be in a group that only does standard exercise. The goal is to find out which combination of treatments helps reduce shoulder pain and improve function over a period of six months.

To be eligible for this trial, participants should be between 40 and 70 years old and have a specific type of frozen shoulder with pain and limited movement lasting between three to nine months. They need to have a certain level of pain and no significant issues with their shoulder joint seen on X-rays. Participants will attend scheduled treatment sessions and will be asked to complete questionnaires about their pain and shoulder function. It’s important to note that people with certain conditions, recent shoulder surgeries, or who are currently involved in other clinical trials won’t be able to participate.

Gender

ALL

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.

About Al Hayah University In Cairo

Al Hayah University in Cairo is a distinguished academic institution dedicated to advancing medical research and education. With a focus on innovative clinical trials and research initiatives, the university aims to contribute to the improvement of healthcare outcomes both locally and globally. By fostering collaboration among researchers, healthcare professionals, and industry partners, Al Hayah University is committed to enhancing the quality of clinical trials, ensuring ethical standards, and promoting scientific excellence in the pursuit of new therapies and medical advancements.

Locations

Cairo, , Egypt

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported