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

28 april 2026 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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

Studietyp

Interventionell

Inskrivning (Faktisk)

70

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Experimentell: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
1. Pain Intensity
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Beni-Suef University

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

  • 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.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

4 oktober 2025

Primärt slutförande (Faktisk)

15 januari 2026

Avslutad studie (Faktisk)

20 april 2026

Studieregistreringsdatum

Först inskickad

28 april 2026

Först inskickad som uppfyllde QC-kriterierna

28 april 2026

Första postat (Faktisk)

5 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 april 2026

Senast verifierad

1 april 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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