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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
180
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.
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.
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.
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.
Faculty of Physical Therapy, Al Hayah University
Cairo, Egypt
RECRUITINGChange 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.
Time frame: 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.
Time frame: Baseline (T0), 6 weeks (T1), 12 weeks (T2), 6 months (T3)
Change in Passive Shoulder Range of Motion (ROM)
Change from baseline in passive shoulder ROM measured in degrees for: External Rotation (at side), Abduction (in scapular plane), Flexion, and Internal Rotation (vertebral level reached). Measured using a standard goniometer.
Time frame: Baseline (T0), 6 weeks (T1), 12 weeks (T2), 6 months (T3)
Patient Global Rating of Change
Global Rating of Change (GRC) Scale. Patient's self-rated overall change in their shoulder condition since starting the study, measured on a Likert scale (e.g., 7-point scale from "very much worse" to "very much improved"). Assessed relative to baseline.
Time frame: 6 weeks (T1), 12 weeks (T2), 6 months (T3)
Incidence of Adverse Events
Number, type, and severity of any adverse events (AEs) reported by participants or observed by study staff throughout the study duration, categorized by potential relationship to the assigned intervention (e.g., post-injection flare, skin reaction to HILT, increased pain after manual therapy/exercise).
Time frame: Throughout study participation (up to 6 months)
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