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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Drug, Device
Study Type: Interventional
Study Phase: Not Applicable
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 joint, and hands-on manual therapy by a physical therapist. A fourth group will receive only the standard exercise program. The goal is to see which combination works best to reduce shoulder pain and improve shoulder function over 6 months. The main outcomes are changes in pain (VAS scale) and shoulder disability (SPADI questionnaire) at 12 weeks.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Egypt
Faculty of Physical Therapy, Al Hayah University
RECRUITING
Cairo
Contact Information
Primary
Ibrahim Zoheiry, Ph.D
ibrahim.alzoheiry@hotmail.com
01277774949
Backup
Mohamed ElMeligie, Ph.D
mohamed.elmeligie@ahuc.edu.eg
Time Frame
Start Date: 2025-04-25
Estimated Completion Date: 2027-08-01
Participants
Target number of participants: 180
Treatments
Experimental: HILT + Standard Exercise
Participants receive High-Intensity Laser Therapy (HILT) 2 times/week for 6 weeks, plus the Standard Exercise Program.
Active_comparator: Corticosteroid Injection + Standard Exercise
Participants receive a single ultrasound-guided intra-articular corticosteroid injection at baseline, plus the Standard Exercise Program.
Active_comparator: Manual Therapy + Standard Exercise
Participants receive manual therapy 2 times/week for 6 weeks, plus the Standard Exercise Program.
Active_comparator: Standard Exercise Alone
Participants receive the Standard Exercise Program only.
Related Therapeutic Areas
Sponsors
Leads: Al Hayah University In Cairo

This content was sourced from clinicaltrials.gov