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

Al Hayah University In Cairo

Status: Enrolling

Conditions: Frozen Shoulder

Treatments: Drug: Ultrasound-Guided Intra-articular Corticosteroid Injection; Behavioral: Standard Exercise Program; Device: High-Intensity Laser Therapy (HILT); Behavioral: Manual Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06916650

COMPARE-FS

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

180 participants in 4 patient groups

HILT + Standard Exercise

Experimental group

Description:

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

Treatment:

Device: High-Intensity Laser Therapy (HILT)

Behavioral: Standard Exercise Program

Corticosteroid Injection + Standard Exercise

Active Comparator group

Description:

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

Treatment:

Behavioral: Standard Exercise Program

Drug: Ultrasound-Guided Intra-articular Corticosteroid Injection

Manual Therapy + Standard Exercise

Active Comparator group

Description:

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

Treatment:

Behavioral: Manual Therapy

Behavioral: Standard Exercise Program

Standard Exercise Alone

Active Comparator group

Description:

Participants receive the Standard Exercise Program only.

Treatment:

Behavioral: Standard Exercise Program