NCT07567703

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 4, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 5, 2026

Completed
Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

April 28, 2026

Last Update Submit

April 28, 2026

Conditions

Keywords

Piriformis Syndrome/ Low-Level Laser Therapy /Shockwave Therapy /Therapeutic Exercise

Outcome Measures

Primary Outcomes (4)

  • 1. Pain Intensity

    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

    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

    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

    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

Study Arms (2)

Laser + Exercise

EXPERIMENTAL

Participants receive low-level laser therapy combined with therapeutic exercise for management of piriformis syndrome.

Device: Low-Level Laser Therapy + Therapeutic Exercise

Shockwave + Exercise Group

EXPERIMENTAL

Participants receive radial extracorporeal shockwave therapy combined with therapeutic exercise.

Device: Radial Shockwave Therapy + Therapeutic Exercise

Interventions

Participants receive low-level laser therapy combined with a structured therapeutic exercise program for management of piriformis syndrome.

Laser + Exercise

Participants receive radial extracorporeal shockwave therapy combined with a structured therapeutic exercise program for management of piriformis syndrome.

Shockwave + Exercise Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient clinics of the Faculty of Physical Therapy, Beni Suef University

Cairo, Egypt

Location

Related Publications (1)

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Piriformis Muscle Syndrome

Interventions

Low-Level Light TherapyExercise Therapy

Condition Hierarchy (Ancestors)

Sciatic NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesNeuralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPelvic Pain

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapyRehabilitationAftercareContinuity of Patient CarePatient CarePhysical Therapy Modalities

Study Officials

  • Sahar M Abdelmutilibe, PHD

    Faculty of Physical Therapy, Beni Suef University, Cairo, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Blinding of participants was not feasible due to the nature of physical therapy modalities.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study is randomized controlled design in which participants were allocated into two independent groups. One group received low-level laser therapy combined with therapeutic exercise, while the other group received radial shockwave therapy combined with the same exercise protocol. Outcomes were compared between the two groups at baseline, post-intervention, and follow-up.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 28, 2026

First Posted

May 5, 2026

Study Start

October 4, 2025

Primary Completion

January 15, 2026

Study Completion

April 20, 2026

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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

Locations