Clinical trial NCT06916650: Comparing HILT, Steroid Injection, and Manual Therapy for Frozen Shoulder
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Frozen Shoulder
Lead sponsor: Al Hayah University In Cairo
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 180
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in Shoulder Pain Intensity
timeFrame: Baseline (T0), 6 weeks (T1), 12 weeks (T2), 6 months (T3)
measure: Change in Shoulder Pain and Disability
timeFrame: Baseline (T0), 6 weeks (T1), 12 weeks (T2), 6 months (T3)
Secondary outcomes:
measure: Change in Passive Shoulder Range of Motion (ROM)
timeFrame: Baseline (T0), 6 weeks (T1), 12 weeks (T2), 6 months (T3)
measure: Patient Global Rating of Change
timeFrame: 6 weeks (T1), 12 weeks (T2), 6 months (T3)
measure: Incidence of Adverse Events
timeFrame: Throughout study participation (up to 6 months)
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy, Al Hayah University
Study officials:
References: