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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Ahmad M. El Melhat, PhD
- Numéro de téléphone: +20 11 12595022
- E-mail: ahmed.elmelhat@cu.edu.eg
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
|
Comparateur factice: 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 |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Pain intensity
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Hip range of motion
Délai: 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
Délai: 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
Délai: 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.
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Ahmad El Melhat, PhD, Cairo University
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- High Intensity Laser Therapy
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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