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The Effectiveness of High-intensity Laser Therapy in Femoroacetabular Impingement Syndrome

2. november 2026 oppdatert av: Ahmed ElMelhat, Cairo University

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

20 år til 45 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: High Intensity Laser Therapy

This group will receive High Intensity Laser Therapy in addition to standard exercise for FAIS
Annen: High intensity Laser Therapy

Participants will receive HILT three times a week for six weeks.

Annen: Standard Exercice program

The standard exercise program will be performed three times a week for 6 weeks.
Sham-komparator: Sham High Intensity Laser Therapy

This group will receive Sham High Intensity Laser Therapy in addition to standard exercise for FAIS.
Annen: Standard Exercice program

The standard exercise program will be performed three times a week for 6 weeks.

Annen: Sham High Intensity Laser Therapy

Participants will receive Sham HILT three times a week for six weeks

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pain intensity
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Hip range of motion
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbeidspartnere og etterforskere

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Sponsor

Cairo University

Etterforskere

  • Studieleder: Ahmad El Melhat, PhD, Cairo University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

15. november 2026

Primær fullføring (Antatt)

15. februar 2027

Studiet fullført (Antatt)

28. februar 2027

Datoer for studieregistrering

Først innsendt

2. november 2026

Først innsendt som oppfylte QC-kriteriene

2. november 2026

Først lagt ut (Faktiske)

6. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • High Intensity Laser Therapy

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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