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

NCT06916650 | Recruiting

• 1 other identifier: COMPARE-FS
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Frozen Shoulder

Outcome Measures

Primary Outcomes (2)

• Change in Shoulder Pain Intensity

  Visual Analogue Scale (VAS) for Pain. Change from baseline in average shoulder pain over the past week, measured on a 10 cm horizontal VAS, where 0 cm = no pain and 10 cm = worst imaginable pain. Lower scores indicate less pain. MCID estimated at 1.4 cm.

  Baseline (T0), 6 weeks (T1), 12 weeks (T2), 6 months (T3)

• Change in Shoulder Pain and Disability

  Shoulder Pain and Disability Index (SPADI). Change from baseline in the total SPADI score. SPADI consists of 13 items assessing pain (5 items) and disability (8 items). Total score ranges from 0-100, with lower scores indicating less pain and disability.

  Baseline (T0), 6 weeks (T1), 12 weeks (T2), 6 months (T3)

Secondary Outcomes (3)

• Change in Passive Shoulder Range of Motion (ROM)

  Baseline (T0), 6 weeks (T1), 12 weeks (T2), 6 months (T3)

• Patient Global Rating of Change

  6 weeks (T1), 12 weeks (T2), 6 months (T3)

• Incidence of Adverse Events

  Throughout study participation (up to 6 months)

Study Arms (4)

HILT + Standard Exercise

EXPERIMENTAL

Participants receive High-Intensity Laser Therapy (HILT) 2 times/week for 6 weeks, plus the Standard Exercise Program.

Device: High-Intensity Laser Therapy (HILT); Behavioral: Standard Exercise Program

Corticosteroid Injection + Standard Exercise

ACTIVE COMPARATOR

Participants receive a single ultrasound-guided intra-articular corticosteroid injection at baseline, plus the Standard Exercise Program.

Drug: Ultrasound-Guided Intra-articular Corticosteroid Injection; Behavioral: Standard Exercise Program

Manual Therapy + Standard Exercise

ACTIVE COMPARATOR

Participants receive manual therapy 2 times/week for 6 weeks, plus the Standard Exercise Program.

Behavioral: Manual Therapy; Behavioral: Standard Exercise Program

Standard Exercise Alone

ACTIVE COMPARATOR

Participants receive the Standard Exercise Program only.

Behavioral: Standard Exercise Program

Interventions

High-Intensity Laser Therapy (HILT) DEVICE

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.

HILT + Standard Exercise

Ultrasound-Guided Intra-articular Corticosteroid Injection DRUG

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.

Corticosteroid Injection + Standard Exercise

Manual Therapy BEHAVIORAL

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.

Manual Therapy + Standard Exercise

Standard Exercise Program BEHAVIORAL

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.

Corticosteroid Injection + Standard Exercise; HILT + Standard Exercise; Manual Therapy + Standard Exercise; Standard Exercise Alone

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al Hayah University In Cairo: lead

Study Sites (1)

Faculty of Physical Therapy, Al Hayah University

Cairo, 12311, Egypt

RECRUITING

MeSH Terms

Conditions

Bursitis

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Ibrahim Zoheiry, Ph.D

CONTACT

01277774949; ibrahim.alzoheiry@hotmail.com

Mohamed ElMeligie, Ph.D

CONTACT

mohamed.elmeligie@ahuc.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 8, 2025
• Study Start: April 25, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)