Frozen ShoulderNCT06916650
Comparing HILT, Steroid Injection, and Manual Therapy for Frozen Shoulder
A study testing High-Intensity Laser Therapy (HILT), Ultrasound-Guided Intra-articular Corticosteroid Injection and Manual Therapy in people with Frozen Shoulder, run by Al Hayah University In Cairo at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Frozen Shoulder
- What is being tested?
- High-Intensity Laser Therapy (HILT), Ultrasound-Guided Intra-articular Corticosteroid Injection and Manual Therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Apr 2025to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mohamed ElMeligie, Ph.D contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy, Al Hayah University
Cairo, 12311
Mohamed ElMeligie, Ph.D, 01159880001 ext. +20, mohamed.elmeligie@ahuc.edu.eg
About this study
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
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
- Being tested
- High-Intensity Laser Therapy (HILT), Ultrasound-Guided Intra-articular Corticosteroid Injection, Manual Therapy, Standard Exercise Program
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 InjectionDrug
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 TherapyBehavioural
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 ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| HILT + Standard Exercise | Experimental | Participants receive High-Intensity Laser Therapy (HILT) 2 times/week for 6 weeks, plus the Standard Exercise Program. Receives: 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. Receives: 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. Receives: Behavioral: Manual Therapy; Behavioral: Standard Exercise Program |
| Standard Exercise Alone | Active comparator | Participants receive the Standard Exercise Program only. Receives: Behavioral: Standard Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (T0), 6 weeks (T1), 12 weeks (T2), 6 months (T3)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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).
Measured: Throughout study participation (up to 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start25 Apr 2025 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al Hayah University In Cairo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916650
- Sponsor's protocol ID
- COMPARE-FS
- Status last verified
- Apr 2025
- First submitted
- 1 Apr 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06916650
- Acronym / sponsor ID
- COMPARE-FS
- Conditions
- Frozen Shoulder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Al Hayah University In CairoUniversity, hospital or other
- Study start
- 25 Apr 2025 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HILT + Standard Exercise | Experimental | Device: High-Intensity Laser Therapy (HILT), Behavioral: Standard Exercise ProgramParticipants receive High-Intensity Laser Therapy (HILT) 2 times/week for 6 weeks, plus the Standard Exercise Program. |
| Corticosteroid Injection + Standard Exercise | Active comparator | Drug: Ultrasound-Guided Intra-articular Corticosteroid Injection, Behavioral: Standard Exercise ProgramParticipants receive a single ultrasound-guided intra-articular corticosteroid injection at baseline, plus the Standard Exercise Program. |
| Manual Therapy + Standard Exercise | Active comparator | Behavioral: Manual Therapy, Behavioral: Standard Exercise ProgramParticipants receive manual therapy 2 times/week for 6 weeks, plus the Standard Exercise Program. |
| Standard Exercise Alone | Active comparator | Behavioral: Standard Exercise ProgramParticipants receive the Standard Exercise Program only. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Intensity Laser Therapy (HILT)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. | Device | HILT + Standard Exercise |
| Ultrasound-Guided Intra-articular Corticosteroid InjectionSingle 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. | Drug | Corticosteroid Injection + Standard Exercise |
| Manual TherapySkilled 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. | Behavioural | Manual Therapy + Standard Exercise |
| Standard Exercise ProgramStandardized 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. | Behavioural | Corticosteroid Injection + Standard Exercise, HILT + Standard Exercise, Manual Therapy + Standard Exercise, Standard Exercise Alone |
Primary outcome
Change in Shoulder Pain Intensity
Time frame: Baseline (T0), 6 weeks (T1), 12 weeks (T2), 6 months (T3)
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.
Change in Shoulder Pain and Disability
Time frame: Baseline (T0), 6 weeks (T1), 12 weeks (T2), 6 months (T3)
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.
3 secondary outcomes
Change in Passive Shoulder Range of Motion (ROM)
Time frame: Baseline (T0), 6 weeks (T1), 12 weeks (T2), 6 months (T3)
Patient Global Rating of Change
Time frame: 6 weeks (T1), 12 weeks (T2), 6 months (T3)
Incidence of Adverse Events
Time frame: Throughout study participation (up to 6 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Frozen Shoulder
Not yet recruiting
Effects of Clinic Versus mHealth Application-Based Shoulder Rehabilitation in Patients With Adhesive Capsulitis
Adhesive Capsulitis
Active, not recruiting
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
Not yet recruiting
Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
Not yet recruiting
Effects of Posterior Capsular Stretching With and Without Dynamic Neuromuscular Stabilization Exercises in Frozen Shoulder
Frozen Shoulder
RecruitingPhase 4
Ultrasound-Guided Intra-Articular vs Gluteal Intramuscular Corticosteroid Injection for Frozen Shoulder
Frozen Shoulder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed ElMeligie, Ph.D contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Laser Therapy (HILT), Ultrasound-Guided Intra-articular Corticosteroid Injection and Manual Therapy in people with Frozen Shoulder, run by Al Hayah University In Cairo at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ibrahim Zoheiry, Ph.D (01277774949, ibrahim.alzoheiry@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Shoulder Pain Intensity (time frame: Baseline (T0), 6 weeks (T1), 12 weeks (T2), 6 months (T3)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.