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NCT Number: NCT07749066

HILT in Greater Trochanteric Pain Syndrome

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.

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Key information

Conditions

Greater Trochanteric Pain Syndrome

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Etlik City Hospital

Ankara, Yenimahalle, 06370, Turkey (Türkiye)

Location status: Recruiting

Location contact

Gizem Suna Tuncer

CONTACT

[email protected]

+905347953185

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Pain Intensity (Visual Analog Scale, VAS)

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

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

Secondary outcomes

  1. Pressure Pain Threshold (Algometry)

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

    Pressure pain threshold will be measured using a digital algometer at the most tender point over the greater trochanter. Measurements will be performed in lateral decubitus position with perpendicular probe application, increasing pressure at approximately 1 kg/s until the first sensation of pain is reported. Three measurements will be taken at 30-second intervals, and the average value (kg/cm²) will be used for analysis. All measurements will be performed by the same assessor.

  2. Lower Extremity Functional Scale (LEFS)

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

    The LEFS is a patient-reported outcome measure assessing difficulty in performing 20 daily activities. Each item is scored from 0 (extreme difficulty or unable to perform) to 4 (no difficulty), with a total score ranging from 0 to 80, where higher scores indicate better function.

  3. Roles and Maudsley Score (RMS)

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

    The Roles and Maudsley Score is a 4-point categorical scale evaluating patient-perceived recovery, ranging from 1 (excellent) to 4 (poor or unchanged symptoms).

  4. Single-Leg Stance Test

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

    The single-leg stance test assesses balance and hip abductor function. Participants stand on one leg with arms relaxed at the sides, maintaining an upright posture. The duration (in seconds) is recorded up to a maximum of 30 seconds. The test is terminated if balance is lost, the non-stance foot touches the ground, or compensatory movements occur.

Study contacts

Contact information is provided by the study sponsor or research team.

Gizem Suna Tuncer, MD, Specialist Physician

CONTACT

[email protected]

+905347953185

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Official study title

Efficacy of High-Intensity Laser Therapy in Greater Trochanteric Pain Syndrome: A Randomized Controlled Trial

Acronym: HILT-GTPS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 6, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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