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

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.

Study Overview

• Status: Completed
• Conditions: Piriformis Syndrome
• Intervention / Treatment: Device: Low-Level Laser Therapy + Therapeutic Exercise; Device: Radial Shockwave Therapy + Therapeutic Exercise

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser + Exercise; Participants receive low-level laser therapy combined with therapeutic exercise for management of piriformis syndrome.	Device: Low-Level Laser Therapy + Therapeutic Exercise; Participants receive low-level laser therapy combined with a structured therapeutic exercise program for management of piriformis syndrome.
Experimental: Shockwave + Exercise Group; Participants receive radial extracorporeal shockwave therapy combined with therapeutic exercise.	Device: Radial Shockwave Therapy + Therapeutic Exercise; Participants receive radial extracorporeal shockwave therapy combined with a structured therapeutic exercise program for management of piriformis syndrome.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Investigators: Principal Investigator: Sahar M Abdelmutilibe, PHD, Faculty of Physical Therapy, Beni Suef University, Cairo, Egypt

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2025
• Primary Completion (Actual): January 15, 2026
• Study Completion (Actual): April 20, 2026

Study Registration Dates

• First Submitted: April 28, 2026
• First Submitted That Met QC Criteria: April 28, 2026
• First Posted (Actual): May 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Piriformis Syndrome/ Low-Level Laser Therapy /Shockwave Therapy /Therapeutic Exercise
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Pelvic Pain; Mononeuropathies; Nerve Compression Syndromes; Sciatic Neuropathy; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Piriformis Muscle Syndrome; Therapeutics; Physical Therapy Modalities; Patient Care; Rehabilitation; Aftercare; Continuity of Patient Care; Laser Therapy; Phototherapy; Exercise Therapy; Low-Level Light Therapy
• Other Study ID Numbers: FPTBSUREC/0212/15426 (Other Identifier: Faculty of Physical Therapy, Beni Suef University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared to protect patient confidentiality and privacy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No