Femoroacetabular Impingement SyndromeNCT07921394
The Effectiveness of High-intensity Laser Therapy in Femoroacetabular Impingement Syndrome
A study testing High intensity Laser Therapy and Standard Exercice program in people with Femoroacetabular Impingement Syndrome and Femoro-acetabular Impingement, run by Cairo University.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Femoroacetabular Impingement Syndrome, Femoro-acetabular Impingement, Femoracetabular Impingement
- What is being tested?
- High intensity Laser Therapy and Standard Exercice program
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2026to 28 Feb 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Femoroacetabular Impingement Syndrome, Femoro-acetabular Impingement, Femoracetabular Impingement, Femoro-acetabular Impingement (FAI)
- Being tested
- High intensity Laser Therapy, Sham High Intensity Laser Therapy, Standard Exercice program
- Keywords
- Femoroacetabular Impingement Syndrome, High Intensity Laser Therapy
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity Laser TherapyOther
Participants will receive HILT three times a week for six weeks.
Sham High Intensity Laser TherapyOther
Participants will receive Sham HILT three times a week for six weeks
Standard Exercice programOther
The standard exercise program will be performed three times a week for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Laser Therapy | Experimental | This group will receive High Intensity Laser Therapy in addition to standard exercise for FAIS Receives: Other: High intensity Laser Therapy; Other: Standard Exercice program |
| Sham High Intensity Laser Therapy | Sham comparator | This group will receive Sham High Intensity Laser Therapy in addition to standard exercise for FAIS. Receives: Other: Sham High Intensity Laser Therapy; Other: Standard Exercice program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity will be measured using the Numeric Pain Rating Scale ( NPRS). Scores range from 0 (no pain) to 10 (worst pain).
Measured: Pre-intervention,post intervention (week 6), and week 12 as follow up.
Secondary outcomes (3)
Hip range of motion
Hip range of motion will be measured using a goniometer , with measurements recorded in degrees.
Measured: Pre-intervention,post intervention (week 6), and week 12 as follow up.
Hip-related quality of life
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).
Measured: Pre-intervention,post intervention (week 6), and week 12 as follow up.
Perceived rate of change
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).
Measured: Pre-intervention,post intervention (week 6), and week 12 as follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start15 Nov 2026 (estimated)
- Primary completion15 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Femoroacetabular Impingement SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed ElMelhat, Cairo University
- Investigators
- Ahmad El Melhat, PhD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07921394
- Sponsor's protocol ID
- High Intensity Laser Therapy
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40967622Kemp 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.
PubMed 33827828Aoyama 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.
PubMed 31241527
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of High-intensity Laser Therapy in Femoroacetabular Impingement Syndrome
- ClinicalTrials.gov ID
- NCT07921394
- Acronym / sponsor ID
- High Intensity Laser Therapy
- Conditions
- Femoroacetabular Impingement Syndrome, Femoro-acetabular Impingement, Femoracetabular Impingement, Femoro-acetabular Impingement (FAI)
- Keywords
- Femoroacetabular Impingement Syndrome, High Intensity Laser Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 6 Nov 2026 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Intensity Laser Therapy | Experimental | Other: High intensity Laser Therapy, Other: Standard Exercice programThis group will receive High Intensity Laser Therapy in addition to standard exercise for FAIS |
| Sham High Intensity Laser Therapy | Sham comparator | Other: Sham High Intensity Laser Therapy, Other: Standard Exercice programThis group will receive Sham High Intensity Laser Therapy in addition to standard exercise for FAIS. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
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 TherapyParticipants will receive HILT three times a week for six weeks. | Other | High Intensity Laser Therapy |
| Sham High Intensity Laser TherapyParticipants will receive Sham HILT three times a week for six weeks | Other | Sham High Intensity Laser Therapy |
| Standard Exercice programThe standard exercise program will be performed three times a week for 6 weeks. | Other | High Intensity Laser Therapy, Sham High Intensity Laser Therapy |
Primary outcome
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).
3 secondary outcomes
Hip range of motion
Time frame: 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.
Perceived rate of change
Time frame: Pre-intervention,post intervention (week 6), and week 12 as follow up.
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 6 Nov 2026.
- Background: PubMed 40967622Pacheco-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.
- Background: PubMed 33827828Kemp 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.
- Background: PubMed 31241527Aoyama 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.
- Individual participant dataSharing planned: No
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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.
Ahmad El Melhat, PhD study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing High intensity Laser Therapy and Standard Exercice program in people with Femoroacetabular Impingement Syndrome and Femoro-acetabular Impingement, run by Cairo University.
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 5 inclusion and 10 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: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Ahmad M. El Melhat, PhD (+20 11 12595022, ahmed.elmelhat@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Pre-intervention,post intervention (week 6), and week 12 as follow up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07921394, which also lists 3 linked publications.
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 6 Nov 2026.