Extracorporeal Shock WaveNCT06762197
Radial Shockwave Versus Low Level Laser Therapy in Patients With Chronic Piriformis Muscle Syndrome
A study testing Conventional treatment, shockwave therapy and low level laser therapy in people with Extracorporeal Shock Wave and Radial Shock Wave, run by Cairo University at 1 site in Egypt.
Trial summary
The study aims to compare the effects of radiation shockwave and low-level laser therapy on piriformis muscle thickness, lower extremity function, pain intensity, and hip range of motion in patients with piriformis syndrome. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Extracorporeal Shock Wave, Radial Shock Wave, Low Level Laser
- What is being tested?
- Conventional treatment, shockwave therapy and low level laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Sixty patients' males and females with piriformis syndrome
- Their age will range from 30-50 years old
- Body mass index will be 25 to 30 (kg/m²).
- Both males and females.
- Low back pain radiating to posterior thigh, calf and Foot.
- Chronic piriformis syndrome due to micro trauma.
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- Gluteal pain with or without radiation through sciatic nerve pathway.
- Faber test and Fair test and Beatty test positive.
- Diagnosed sub-acute and chronic piriformis syndrome.
- One-sided piriformis syndrome.
- Tenderness over lower back, buttocks and hip joint.
Who cannot join
- Piriformis syndrome due to macro trauma.
- Lumbo-sacral disc lesion and spinal stenosis.
- Lumbar spondylolisthesis.
- Pregnancy
- Recent fracture and surgery of spine, hip, knee and Ankle.
- Baker's cyst.
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- Degenerative disease of spine and hip.
- Intermittent vascular claudication.
- Past history of vertebral fracture and spinal surgery
- Spinal tuberculosis.
- Rheumatoid disease.
- Disc pathology and mechanical back pain.
- Presence of malignant disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
out-patient clinic in physiotherapy department at EL KATEB Hospital
Giza
Mohamed Mahdy Ali, physical therapist, 01111153111, m_mahdy142@yahoo.com
About this study
Official title: Radial Extracorporeal Shockwave Versus Low Level Laser Therapy in Management of Patients With Chronic Piriformis Muscle Syndrome
The study aims to compare the effects of radiation shockwave and low-level laser therapy on piriformis muscle thickness, lower extremity function, pain intensity, and hip range of motion in patients with piriformis syndrome.
Read the detailed description
Low back pain affects 75%-84% of the general population in developed countries, with piriformis syndrome being more common in women. piriformis syndrome is a neuromuscular disorder caused by the compression of the sciatic nerve in the infra-piriformis canal, causing sciatic pain, tingling, and numbness. Few studies have examined the effectiveness of shockwave therapy in treating piriformis syndrome, but this study aims to compare results to improve treatment outcomes, save time and money, and add value to physical therapy.
- Being tested
- Conventional treatment, shockwave therapy, low level laser therapy
- 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.
Conventional treatmentOther
Physical therapy can be beneficial for patients with piriformis syndrome, including stretching exercises, local massage, and superficial heat. Traditional stretching techniques include external rotation, hip flexion, and adduction. A hot pack on the trigger point area for 10 minutes followed by passive stretching for 30 seconds each.
shockwave therapyDevice
Shockwave therapy is a non-invasive alternative treatment for muscle disorders like sports and traumatic injuries, as it reduces pain and promotes soft tissue repair. In a study, patients in group A were treated with three sessions of Storz Medical Shock Wave MP100, each consisting of 2000 pulses with a total energy dose of 1080 mJ / mm. The study aimed to determine the location of the piriformis muscle in the prone position.
low level laser therapyDevice
Low Level Laser Therapy, also known as Photo-biomodulation, is a low-intensity light therapy that triggers biochemical changes within cells, similar to photosynthesis in plants. It can treat nociceptive and neuropathic pain, but central pain has not been proven responsive to low level laser therapy.
| Study group | Role | What they receive |
|---|---|---|
| conventional program | Active comparator | twenty one patients of chronic piriformis muscle syndrome will be treated by the conventional physical therapy program in the form of (hot packs, local massage and stretching exercise) for 6 weeks (two times per week). Receives: Other: Conventional treatment |
| Radial Extracorporeal shock wave | Experimental | twenty one patients of chronic piriformis muscle syndrome will be treated with Radial Extracorporeal shock wave in addition to the conventional physical therapy program in the form of (hot packs, local massage and stretching exercise) for 6 weeks (two times per week). Receives: Other: Conventional treatment; Device: shockwave therapy |
| low level laser therapy | Experimental | twenty one patients of chronic piriformis muscle syndrome will be treated with low level laser therapy in addition to the conventional physical therapy program in the form of (hot packs, local massage and stretching exercise) for 6 weeks (two times per week). Receives: Other: Conventional treatment; Device: low level laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the change of body mass index
Weight and height Scale will be used to measure body mass index
Measured: at baseline and after 6 weeks
assessing the change of pain intensity
The 10-cm visual analogue scale has been proven reliable, valid, and responsive for assessing pain levels, with 0 indicating no pain and 10 indicating the worst pain possible, demonstrating its effectiveness in measuring pain.
Measured: at baseline and after 6 weeks
Secondary outcomes (3)
assessing the change of functional status
The patient's functional status is assessed using the Lower Extremity Functional Scale before treatment. This self-assessment tool is valid and reliable, and the patient's score on the questionnaire is evaluated. The scale is free for clinical or research purposes.
Measured: at baseline and after 6 weeks
assessing the change of range of motion of lower limb
Goniometer measurement is used to assess the range of motion of hip internal and external rotation before and after intervention. This simple test is accurate and reliable in detecting changes in hip range of motion, making it a valid measure to detect underlying hip pathology and enable surgical intervention based on it.
Measured: at baseline and after 6 weeks
assessing the change of piriformis muscle thickness
Ultrasound guided measurement for piriformis M.sc thickness may be a reliable technique for early diagnosis of post-operative pain syndrome, increasing conservative treatment options and routinely evaluating patients with unidentified causes of buttock pain. The technique involves placing a probe in the patient's prone position, moving the patient's lower leg to confirm the piriformis position, and measuring piriformis thickness in the medial part of the ischium.
Measured: at baseline and after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start1 Jan 2025 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracorporeal Shock WaveStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mahdi Ali Ibrahim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762197
- Sponsor's protocol ID
- Mohamed-004968
- Status last verified
- Jan 2025
- First submitted
- 1 Jan 2025
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radial Extracorporeal Shockwave Versus Low Level Laser Therapy in Management of Patients With Chronic Piriformis Muscle Syndrome
- ClinicalTrials.gov ID
- NCT06762197
- Acronym / sponsor ID
- Mohamed-004968
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 7 Jan 2025 (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.
The study aims to compare the effects of radiation shockwave and low-level laser therapy on piriformis muscle thickness, lower extremity function, pain intensity, and hip range of motion in patients with piriformis syndrome.
Detailed description
Low back pain affects 75%-84% of the general population in developed countries, with piriformis syndrome being more common in women. piriformis syndrome is a neuromuscular disorder caused by the compression of the sciatic nerve in the infra-piriformis canal, causing sciatic pain, tingling, and numbness. Few studies have examined the effectiveness of shockwave therapy in treating piriformis syndrome, but this study aims to compare results to improve treatment outcomes, save time and money, and add value to physical therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| conventional program | Active comparator | Other: Conventional treatmenttwenty one patients of chronic piriformis muscle syndrome will be treated by the conventional physical therapy program in the form of (hot packs, local massage and stretching exercise) for 6 weeks (two times per week). |
| Radial Extracorporeal shock wave | Experimental | Other: Conventional treatment, Device: shockwave therapytwenty one patients of chronic piriformis muscle syndrome will be treated with Radial Extracorporeal shock wave in addition to the conventional physical therapy program in the form of (hot packs, local massage and stretching exercise) for 6 weeks (two times per week). |
| low level laser therapy | Experimental | Other: Conventional treatment, Device: low level laser therapytwenty one patients of chronic piriformis muscle syndrome will be treated with low level laser therapy in addition to the conventional physical therapy program in the form of (hot packs, local massage and stretching exercise) for 6 weeks (two times per week). |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Sixty patients' males and females with piriformis syndrome
- Both males and females.
- Low back pain radiating to posterior thigh, calf and Foot.
- Chronic piriformis syndrome due to micro trauma.
- Gluteal pain with or without radiation through sciatic nerve pathway.
Key exclusion criteria (13 listed)
- Piriformis syndrome due to macro trauma.
- Lumbo-sacral disc lesion and spinal stenosis.
- Lumbar spondylolisthesis.
- Pregnancy
- Recent fracture and surgery of spine, hip, knee and Ankle.
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 |
|---|---|---|
| Conventional treatmentPhysical therapy can be beneficial for patients with piriformis syndrome, including stretching exercises, local massage, and superficial heat. Traditional stretching techniques include external rotation, hip flexion, and adduction. A hot pack on the trigger point area for 10 minutes followed by passive stretching for 30 seconds each. | Other | Radial Extracorporeal shock wave, conventional program, low level laser therapy |
| shockwave therapyShockwave therapy is a non-invasive alternative treatment for muscle disorders like sports and traumatic injuries, as it reduces pain and promotes soft tissue repair. In a study, patients in group A were treated with three sessions of Storz Medical Shock Wave MP100, each consisting of 2000 pulses with a total energy dose of 1080 mJ / mm. The study aimed to determine the location of the piriformis muscle in the prone position. | Device | Radial Extracorporeal shock wave |
| low level laser therapyLow Level Laser Therapy, also known as Photo-biomodulation, is a low-intensity light therapy that triggers biochemical changes within cells, similar to photosynthesis in plants. It can treat nociceptive and neuropathic pain, but central pain has not been proven responsive to low level laser therapy. | Device | low level laser therapy |
Primary outcome
Assessing the change of body mass index
Time frame: at baseline and after 6 weeks
Weight and height Scale will be used to measure body mass index
assessing the change of pain intensity
Time frame: at baseline and after 6 weeks
The 10-cm visual analogue scale has been proven reliable, valid, and responsive for assessing pain levels, with 0 indicating no pain and 10 indicating the worst pain possible, demonstrating its effectiveness in measuring pain.
3 secondary outcomes
assessing the change of functional status
Time frame: at baseline and after 6 weeks
assessing the change of range of motion of lower limb
Time frame: at baseline and after 6 weeks
assessing the change of piriformis muscle thickness
Time frame: at baseline and after 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional treatment, shockwave therapy and low level laser therapy in people with Extracorporeal Shock Wave and Radial Shock Wave, run by Cairo 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 11 inclusion and 13 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: opening soon, as of the sponsor's last update on 7 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Mahdy Ali, physical therapist (01111153111, M_mahdy142@yaho.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the change of body mass index (time frame: at baseline and after 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2025.