Piriformis SyndromeLASWEX-PSNCT07567703
Comparison of Laser and Shockwave Therapy for Piriformis Syndrome With Adjunctive Exercise
A study testing Low-Level Laser Therapy + Therapeutic Exercise and Radial Shockwave Therapy + Therapeutic Exercise in people with Piriformis Syndrome, run by Beni-Suef University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Piriformis Syndrome
- What is being tested?
- Low-Level Laser Therapy + Therapeutic Exercise and Radial Shockwave Therapy + Therapeutic Exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Oct 2025to 20 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient clinics of the Faculty of Physical Therapy, Beni Suef University
Cairo
About this study
Official title: 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.
Read the 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
- Conditions
- Piriformis Syndrome
- Being tested
- Low-Level Laser Therapy + Therapeutic Exercise, Radial Shockwave Therapy + Therapeutic Exercise
- Keywords
- Piriformis Syndrome/ Low-Level Laser Therapy /Shockwave Therapy /Therapeutic Exercise
- Medical subject headings
- Piriformis Muscle Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Level Laser Therapy + Therapeutic ExerciseDevice
Participants receive low-level laser therapy combined with a structured therapeutic exercise program for management of piriformis syndrome.
Radial Shockwave Therapy + Therapeutic ExerciseDevice
Participants receive radial extracorporeal shockwave therapy combined with a structured therapeutic exercise program for management of piriformis syndrome.
| Study group | Role | What they receive |
|---|---|---|
| Laser + Exercise | Experimental | Participants receive low-level laser therapy combined with therapeutic exercise for management of piriformis syndrome. Receives: Device: Low-Level Laser Therapy + Therapeutic Exercise |
| Shockwave + Exercise Group | Experimental | Participants receive radial extracorporeal shockwave therapy combined with therapeutic exercise. Receives: Device: Radial Shockwave Therapy + Therapeutic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Pain Intensity
- 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, post-intervention (4 weeks), and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start4 Oct 2025
- Primary completion15 Jan 2026
- Study completion20 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Piriformis SyndromeStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahar Mowad Abdelmutilibe, Beni-Suef University
- Investigators
- Sahar M Abdelmutilibe, PHD, Principal investigator, Faculty of Physical Therapy, Beni Suef University, Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07567703
- Sponsor's protocol ID
- FPTBSUREC/0212/15426
- Other IDs
- FPTBSUREC/0212/15426
- Acronym
- LASWEX-PS
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect patient confidentiality and privacy.
Publications
DE Oliveira MF, 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 Apr;58(2):282-289. doi: 10.23736/S1973-9087.21.07236-1. Epub 2021 Dec 16.
PubMed 34913330
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Laser Therapy and Shockwave Therapy in the Treatment of Piriformis Syndrome: The Role of Exercise as an Adjunctive Treatment
- ClinicalTrials.gov ID
- NCT07567703
- Acronym / sponsor ID
- LASWEX-PS / FPTBSUREC/0212/15426
- Conditions
- Piriformis Syndrome
- Keywords
- Piriformis Syndrome/ Low-Level Laser Therapy /Shockwave Therapy /Therapeutic Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 4 Oct 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 20 Apr 2026 (actual)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Laser + Exercise | Experimental | Device: Low-Level Laser Therapy + Therapeutic ExerciseParticipants receive low-level laser therapy combined with therapeutic exercise for management of piriformis syndrome. |
| Shockwave + Exercise Group | Experimental | Device: Radial Shockwave Therapy + Therapeutic ExerciseParticipants receive radial extracorporeal shockwave therapy combined with therapeutic exercise. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Level Laser Therapy + Therapeutic ExerciseParticipants receive low-level laser therapy combined with a structured therapeutic exercise program for management of piriformis syndrome. | Device | Laser + Exercise |
| Radial Shockwave Therapy + Therapeutic ExerciseParticipants receive radial extracorporeal shockwave therapy combined with a structured therapeutic exercise program for management of piriformis syndrome. | Device | Shockwave + Exercise Group |
Primary outcome
1. Pain Intensity
Time frame: 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).
2. Hip Range of Motion
Time frame: 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.
3. Quality of Life
Time frame: Baseline, post-intervention (4 weeks), and 3-month follow-up
Health-related quality of life will be assessed using the SF-36 questionnaire.
Functional Disability
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Background: PubMed 34913330DE Oliveira MF, 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 Apr;58(2):282-289. doi: 10.23736/S1973-9087.21.07236-1. Epub 2021 Dec 16.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect patient confidentiality and privacy.
Related trials for Piriformis Syndrome
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Comparative Effects of Post-Isometric Relaxation and Reciprocal Inhibition Techniques inPiriformis Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sahar M Abdelmutilibe, PHD principal investigator
Faculty of Physical Therapy, Beni Suef University, Cairo, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Level Laser Therapy + Therapeutic Exercise and Radial Shockwave Therapy + Therapeutic Exercise in people with Piriformis Syndrome, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Pain Intensity (time frame: 1. Baseline, post-intervention (4 weeks), and 3-month follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07567703, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.