RecruitingNot ApplicableNCT06916650

Comparing HILT, Steroid Injection, and Manual Therapy 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


Sponsor

Al Hayah University In Cairo

Enrollment

180 participants

Start Date

Apr 25, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 40 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called High-Intensity Laser Therapy (HILT), a behavioral approach called Manual Therapy, and others for people with frozen shoulder. The study is currently recruiting participants at 1 location. People eligible for this study include aged 40 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHigh-Intensity Laser Therapy (HILT)

Nd:YAG laser (1064 nm) applied to anterior, lateral, posterior glenohumeral joint aspects. Three-phase protocol per session: (1) 10 J/cm² @ 10 Hz; (2) 12 J/cm² @ 2000 Hz; (3) 10 J/cm² @ 15 Hz. Total energy \~1200 J/session. Frequency: 2 sessions/week for 6 weeks (12 sessions total). Delivered by trained PTs.

DRUGUltrasound-Guided Intra-articular Corticosteroid Injection

Single injection into the glenohumeral joint under ultrasound guidance. Consists of 40 mg methylprednisolone acetate combined with 4 ml of 1% lidocaine hydrochloride. Delivered at baseline by an experienced orthopedic physician.

BEHAVIORALManual Therapy

Skilled hands-on techniques including glenohumeral joint mobilizations (Maitland grades III-IV), posterior capsule stretching, scapular mobilization, and soft tissue techniques targeting restricted tissues. Session duration: \~30 minutes. Frequency: 2 sessions/week for 6 weeks (12 sessions total). Delivered by PTs specialized in manual therapy.

BEHAVIORALStandard Exercise Program

Standardized program including pendulum exercises, active-assisted range of motion exercises (e.g., wand, wall climbs), stretching (e.g., cross-body, sleeper stretch), and progressive resistive exercises using resistance bands. Includes supervised instruction/progression and a daily home exercise program component. Supervised instruction frequency: 2 sessions/week for first 6 weeks, then 1 session/week for next 6 weeks (total 18 supervised sessions over 12 weeks). Delivered by trained PTs.


Locations(1)

Faculty of Physical Therapy, Al Hayah University

Cairo, Egypt

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