The Effectiveness of High-intensity Laser Therapy in Femoroacetabular Impingement Syndrome
The goal of this randomized clinical trial is to evaluate the effects of high-intensity laser therapy on pain intensity, quality of life, hip range of motion, and global rating of change in individuals with femoroacetabular impingement syndrome (FAIS).
The main questions it aims to answer are: Does high-intensity laser therapy improve pain intensity, quality of life, hip range of motion, and global rating of change in patients with Femoroacetabular Impingement Syndrome? Does adding high-intensity laser therapy to exercise therapy produce greater improvements in pain intensity, quality of life, hip range of motion, and global rating of change in patients with Femoroacetabular Impingement Syndrome?
Participants will be randomly assigned to one of two groups for comparison. The first group (control group) will receive a standardized exercise therapy program consistent with routine exercises for femoroacetabular impingement syndrome, along with sham high-intensity laser therapy. The second group (experimental group) will receive the same standardized exercise therapy program in addition to active high-intensity laser therapy.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
High-intensity laser therapy (HILT) is a non-invasive therapeutic modality that uses high-intensity laser energy to penetrate tissues and promote pain relief and tissue healing. Emerging evidence suggests that HILT may be effective in reducing musculoskeletal pain and improving joint range of motion in individuals with shoulder and knee conditions. However, evidence regarding its effectiveness in individuals with femoroacetabular impingement syndrome (FAIS) remains limited. Thus, the investigators hypothesized that HILT would improve pain intensity, quality of life, hip range of motion, and global rating of change in individuals with FAIS.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ahmad M. El Melhat, PhD
- Phone Number: +20 11 12595022
- Email: ahmed.elmelhat@cu.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults aged 20-45 years
- Anterior hip or groin pain with an average intensity of at least 3/10 persisting for a minimum of six weeks
- Pain aggravated by prolonged sitting or hip movements involving impingement positions
- Positive flexion, adduction, and internal rotation (FADIR) test
- Radiographic evidence of cam morphology, with an alpha angle ≥60° in at least one hip
Exclusion Criteria:
- Physiotherapist-led treatment or intra-articular hip injection within the previous three months
- Previous hip, pelvic, or spinal surgery
- Planned lower-limb surgery within the following 12 months
- Moderate-to-severe hip osteoarthritis (Kellgren-Lawrence grade ≥2)
- Neurological, systemic arthritic, or other musculoskeletal conditions primarily responsible for hip pain
- Inability to complete the assessments or commit to the six-month treatment and follow-up period
- Contraindications to radiographic imaging
- Pregnancy at enrollment or during the trial
- Contraindications to high-intensity laser therapy (HILT), including known or suspected malignancy in the treatment area, photosensitivity or use of photosensitizing medications, active deep vein thrombosis, and impaired sensation in the treatment area
- Inability to comply with laser safety precautions, including the use of protective eyewear
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High Intensity Laser Therapy
This group will receive High Intensity Laser Therapy in addition to standard exercise for FAIS |
Participants will receive HILT three times a week for six weeks. The standard exercise program will be performed three times a week for 6 weeks. |
|
Sham Comparator: Sham High Intensity Laser Therapy
This group will receive Sham High Intensity Laser Therapy in addition to standard exercise for FAIS. |
The standard exercise program will be performed three times a week for 6 weeks. Participants will receive Sham HILT three times a week for six weeks |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity
Time Frame: Pre-intervention,post intervention (week 6), and week 12 as follow up.
|
Pain intensity will be measured using the Numeric Pain Rating Scale ( NPRS). Scores range from 0 (no pain) to 10 (worst pain). |
Pre-intervention,post intervention (week 6), and week 12 as follow up.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hip range of motion
Time Frame: Pre-intervention,post intervention (week 6), and week 12 as follow up.
|
Hip range of motion will be measured using a goniometer , with measurements recorded in degrees. |
Pre-intervention,post intervention (week 6), and week 12 as follow up.
|
|
Hip-related quality of life
Time Frame: Pre-intervention,post intervention (week 6), and week 12 as follow up.
|
The hip-related quality of life will be measured using the International Hip Outcome Tool (iHOT-33). Scores range from 0 (worst possible hip-related quality of life) to 100 (best possible hip-related quality of life). |
Pre-intervention,post intervention (week 6), and week 12 as follow up.
|
|
Perceived rate of change
Time Frame: Pre-intervention,post intervention (week 6), and week 12 as follow up.
|
The perceived rate of change will be measured using the Global Rating of Change (GROC). Scores range from negative values (worsening) to 0 (no change) and positive values (improvement). |
Pre-intervention,post intervention (week 6), and week 12 as follow up.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ahmad El Melhat, PhD, Cairo University
Publications and helpful links
General Publications
- Aoyama M, Ohnishi Y, Utsunomiya H, Kanezaki S, Takeuchi H, Watanuki M, Matsuda DK, Uchida S. A Prospective, Randomized, Controlled Trial Comparing Conservative Treatment With Trunk Stabilization Exercise to Standard Hip Muscle Exercise for Treating Femoroacetabular Impingement: A Pilot Study. Clin J Sport Med. 2019 Jul;29(4):267-275. doi: 10.1097/JSM.0000000000000516.
- Pacheco-Brousseau L, Beaule PE, Carsen S, Wilkin G, Grammatopoulos G, Poitras S. Efficacy of a home-based hip exercise programme for patients with symptomatic cam femoroacetabular impingement: a randomized controlled trial. Bone Jt Open. 2025 Sep 19;6(9):1138-1145. doi: 10.1302/2633-1462.69.BJO-2025-0125.R1.
- Kemp JL, Johnston RTR, Coburn SL, Jones DM, Schache AG, Mentiplay BF, King MG, Scholes MJ, De Oliveira Silva D, Smith A, McPhail SM, Crossley KM. Physiotherapist-led treatment for femoroacetabular impingement syndrome (the PhysioFIRST study): a protocol for a participant and assessor-blinded randomised controlled trial. BMJ Open. 2021 Apr 7;11(4):e041742. doi: 10.1136/bmjopen-2020-041742.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- High Intensity Laser Therapy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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