Health TrialsbyHealthPanel

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

ConditionFrozen Shoulder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-70
SponsorAl Hayah University In Cairo

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

  • 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.

Treatment groups

180 Participants
are divided into 4 treatment groups
Group A: HILT + Standard ExerciseExperimental treatment 2 interventions
Group B: Corticosteroid Injection + Standard ExerciseActive comparator 2 interventions
Group C: Manual Therapy + Standard ExerciseActive comparator 2 interventions
Group D: Standard Exercise AloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (T0), 6 weeks (T1), 12 weeks (T2), 6 months (T3)
2

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)

Secondary outcomes

1

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)
2

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)
3

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Al Hayah University In Cairo

Lead sponsor

Source ClinicalTrials.gov
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