HILT in Greater Trochanteric Pain Syndrome

NCT07749066 | Recruiting

• 1 other identifier: AESH-EK-2026-064
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Greater Trochanteric Pain Syndrome (GTPS) is a common cause of lateral hip pain that can significantly impair daily activities and quality of life. Conservative treatments, including physical therapy modalities and injections, are considered first-line management. High-Intensity Laser Therapy (HILT) is a non-invasive modality with greater tissue penetration compared to low-level laser therapy and has shown promising results in musculoskeletal disorders; however, evidence in GTPS is limited. This study aims to evaluate the efficacy of HILT compared with a sham intervention in patients with GTPS, focusing on pain intensity, functional status, and quality of life.

Conditions

Greater Trochanteric Pain Syndrome

Keywords

Greater Trochanteric Pain Syndrome; GTPS; High-Intensity Laser Therapy; HILT; Lateral Hip Pain

Outcome Measures

Primary Outcomes (1)

• Pain Intensity (Visual Analog Scale, VAS)

  Pain intensity will be assessed using a 0-10 Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates worst imaginable pain.

  Baseline (T0), 2 weeks (end of the treatment period; T1), and 8 weeks after treatment completion (T2).

Secondary Outcomes (4)

• Pressure Pain Threshold (Algometry)

  Baseline (T0), 2 weeks (end of the treatment period; T1), and 8 weeks after treatment completion (T2).

• Lower Extremity Functional Scale (LEFS)

  Baseline (T0), 2 weeks (end of the treatment period; T1), and 8 weeks after treatment completion (T2).

• Roles and Maudsley Score (RMS)

  2 weeks (end of the treatment period; T1), and 8 weeks after treatment completion (T2).

• Single-Leg Stance Test

  Baseline (T0), 2 weeks (end of the treatment period; T1), and 8 weeks after treatment completion (T2).

Study Arms (2)

High-Intensity Laser Therapy (HILT) + Exercise

ACTIVE COMPARATOR

Participants will receive high-intensity laser therapy (HILT) in addition to a standardized home exercise program. The exercise program will include hip strengthening, stretching, and movement control exercises targeting the gluteal muscles and peri-trochanteric soft tissues. HILT will be applied to the greater trochanteric region over 10 treatment sessions (5 sessions per week for 2 consecutive weeks) using a standardized treatment protocol.

Device: High-Intensity Laser Therapy (HILT)

Sham Laser + Exercise (Control Group)

SHAM COMPARATOR

Participants will receive the same standardized home exercise program as the intervention group. In addition, a sham laser treatment will be applied using the same device and treatment setup without delivering therapeutic laser energy. The number and frequency of sessions will be identical to the active treatment group to ensure blinding.

Device: Sham Laser

Interventions

High-Intensity Laser Therapy (HILT) DEVICE

High-intensity laser therapy will be applied to the trochanteric region using a pulsed Nd:YAG laser device over 10 sessions (5 sessions per week for 2 consecutive weeks). Treatments will be delivered by an experienced physiotherapist using a standardized protocol and consistent application technique. Total energy per session will be standardized. Participants will also perform a structured home exercise program focusing on hip muscle activation and flexibility.

High-Intensity Laser Therapy (HILT) + Exercise

Sham Laser DEVICE

A sham laser intervention will be applied using the same device and treatment setup without delivering therapeutic laser energy. The number and frequency of sessions will be identical to the active treatment group to ensure blinding. Participants will also perform the same structured home exercise program as the intervention group.

Sham Laser + Exercise (Control Group)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 to 80 years
• Patients diagnosed with Greater Trochanteric Pain Syndrome (GTPS) based on clinical examination
• Presence of symptoms for at least 3 months
• Pain intensity ≥4 on the Visual Analog Scale (VAS)
• No corticosteroid injection or other conservative treatment within the last 3 months

You may not qualify if:

• Hip fracture, tumor, infection, or advanced osteoarthritis
• Contraindications to high-intensity laser therapy (e.g., pacemaker, pregnancy, coagulation disorders, anticoagulant therapy, neoplasia, history of epilepsy)
• Contraindications to physical activity (e.g., ischemic heart disease, arrhythmia, uncontrolled hypertension, heart failure, severe respiratory insufficiency)
• Peripheral vascular disorders (e.g., thrombophlebitis, thrombosis, lymphedema)
• History of trauma within the last 3 months or prior surgery involving the lower extremity or lumbar spine
• Neurological disorders or chronic inflammatory diseases

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Etlik City Hospital

Ankara, Yenimahalle, 06370, Turkey (Türkiye)

RECRUITING

Study Officials

• Gizem Suna Tuncer, MD, Specialist Physician

  Ankara Etlik City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gizem Suna Tuncer, MD, Specialist Physician

CONTACT

+905347953185; sunagizem05@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Physical Medicine and Rehabilitation Specialist

Model Details: This is a randomized, double-blind, sham-controlled, parallel-group study in which patients with GTPS are allocated to HILT or sham treatment, with outcomes assessed at baseline, post-treatment, and follow-up.

Study Record Dates

• First Submitted: July 19, 2026
• First Posted: August 6, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: August 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)