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Comparison of Laser and Shockwave Therapy for Piriformis Syndrome With Adjunctive Exercise (LASWEX-PS)

28. april 2026 oppdatert av: Sahar Mowad Abdelmutilibe, Beni-Suef University

A Comparative Study of Laser Therapy and Shockwave Therapy in the Treatment of Piriformis Syndrome: The Role of Exercise as an Adjunctive Treatment

This study is a prospective randomized controlled trial comparing the effectiveness of low-level laser therapy combined with exercise versus radial extracorporeal shockwave therapy combined with exercise in patients with piriformis syndrome. The interventions were applied over four weeks, and outcomes included pain intensity, functional disability, range of motion, and quality of life.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Piriformis syndrome is a common musculoskeletal condition that contributes to chronic low back and gluteal pain, often leading to functional limitations. This prospective randomized controlled trial was conducted to compare the effectiveness of low-level laser therapy (LLLT) combined with therapeutic exercise versus radial extracorporeal shockwave therapy (rESWT) combined with exercise in patients with piriformis syndrome.

A total of 70 participants were randomly assigned into two equal groups. Both interventions were administered over a period of four weeks, with follow-up assessment conducted one month post-treatment. Outcome measures included pain intensity using the Visual Analog Scale (VAS), functional disability using the Oswestry Disability Index (ODI), hip range of motion (ROM), and quality of life using the Short Form-36 (SF-36).

Inclusion criteria:

Adults aged 18 to 65 years who had a confirmed diagnosis of piriformis syndrome. piriformis syndrome required a positive FAIR test and EMG evidence of sciatic nerve involvement. Eligible participants had chronic symptoms lasting at least three months and a baseline Visual Analog Scale (VAS) pain score of ≥4.

Exclusion criteria:

Participants were excluded if they had a history of surgical interventions involving the lumbar spine, sacroiliac joint, or hip; systemic inflammatory diseases such as ankylosing spondylitis or rheumatoid arthritis; neurological disorders impairing lower limb function; or were pregnant or lactating. Individuals with malignancy, bleeding disorders, or pacemaker implantation Pain Intensity measured by Visual Analogue Scale (VAS), Functional Disability - Oswestry Disability Index (ODI) was used to assess functional impairment in lower back pain and functional limitations., Range of Motion (ROM):It had been used to assess joint mobility will be assessed using a standard goniometer, Quality of Life - Short Form-36 (SF-36): Health-related quality of life will be assessed using the Short Form-36 (SF-36) questionnaire assessment performed at baseline , posttreatment after 4 weeks and 3 months follow up post treatment

Studietype

Intervensjonell

Registrering (Faktiske)

70

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

  • Egypt
      • Cairo, Egypt
        • Outpatient clinics of the Faculty of Physical Therapy, Beni Suef University

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

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Adults aged 18 to 65 years who had a confirmed diagnosis of piriformis syndrome. piriformis syndrome required a positive FAIR test and EMG evidence of sciatic nerve involvement. Eligible participants had chronic symptoms lasting at least three months and a baseline Visual Analog Scale (VAS) pain score of ≥4.

Exclusion Criteria:

  • Participants were excluded if they had a history of surgical interventions involving the lumbar spine, sacroiliac joint, or hip; systemic inflammatory diseases such as ankylosing spondylitis or rheumatoid arthritis; neurological disorders impairing lower limb function; or were pregnant or lactating. Individuals with malignancy, bleeding disorders, or pacemaker implantation

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: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Laser + Exercise
Participants receive low-level laser therapy combined with therapeutic exercise for management of piriformis syndrome.
Enhet: Low-Level Laser Therapy + Therapeutic Exercise
Participants receive low-level laser therapy combined with a structured therapeutic exercise program for management of piriformis syndrome.
Eksperimentell: Shockwave + Exercise Group
Participants receive radial extracorporeal shockwave therapy combined with therapeutic exercise.
Enhet: Radial Shockwave Therapy + Therapeutic Exercise
Participants receive radial extracorporeal shockwave therapy combined with a structured therapeutic exercise program for management of piriformis syndrome.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
1. Pain Intensity
Tidsramme: 1. Baseline, post-intervention (4 weeks), and 3-month follow-up
1. Pain intensity will be assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain).
1. Baseline, post-intervention (4 weeks), and 3-month follow-up
2. Hip Range of Motion
Tidsramme: Baseline, post-intervention (4 weeks), and 3-month follow-up
Hip joint range of motion will be measured in degrees using a standard universal goniometer.
Baseline, post-intervention (4 weeks), and 3-month follow-up
3. Quality of Life
Tidsramme: Baseline, post-intervention (4 weeks), and 3-month follow-up
Health-related quality of life will be assessed using the SF-36 questionnaire.
Baseline, post-intervention (4 weeks), and 3-month follow-up
Functional Disability
Tidsramme: Baseline, post-intervention (4 weeks), and 3-month follow-up
Functional disability will be evaluated using the Oswestry Disability Index (ODI), which measures disability related to low back and gluteal pain.
Baseline, post-intervention (4 weeks), and 3-month follow-up

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Beni-Suef University

Etterforskere

  • Hovedetterforsker: Sahar M Abdelmutilibe, PHD, Faculty of Physical Therapy, Beni Suef University, Cairo, Egypt

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

  • MF DEO, Johnson DS, Demchak T, Tomazoni SS, Leal-Junior EC. Low-intensity LASER and LED (photobiomodulation therapy) for pain control of the most common musculoskeletal conditions. Eur J Phys Rehabil Med. 2022;58(2):282-9.

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 (Faktiske)

4. oktober 2025

Primær fullføring (Faktiske)

15. januar 2026

Studiet fullført (Faktiske)

20. april 2026

Datoer for studieregistrering

Først innsendt

28. april 2026

Først innsendt som oppfylte QC-kriteriene

28. april 2026

Først lagt ut (Faktiske)

5. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. april 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • FPTBSUREC/0212/15426 (Annen identifikator: Faculty of Physical Therapy, Beni Suef University)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data will not be shared to protect patient confidentiality and privacy.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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