Radial Shockwave Versus Low Level Laser Therapy in Patients With Chronic Piriformis Muscle Syndrome

NCT ID: NCT06762197

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2025-04-01

Brief 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.

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.

Conditions

Extracorporeal Shock Wave; Radial Shock Wave; Low Level Laser; Piriformis Muscle Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

conventional program

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).

Group Type: ACTIVE_COMPARATOR

Conventional treatment

Intervention Type: OTHER

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.

Radial Extracorporeal shock wave

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).

Group Type: EXPERIMENTAL

Conventional treatment

Intervention Type: OTHER

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 therapy

Intervention Type: DEVICE

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 therapy

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).

Group Type: EXPERIMENTAL

Conventional treatment

Intervention Type: OTHER

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.

low level laser therapy

Intervention Type: DEVICE

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.

Interventions

Conventional treatment

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.

Intervention Type: OTHER

shockwave therapy

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.

Intervention Type: DEVICE

low level laser therapy

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.
• 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.

Exclusion Criteria

• 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.
• 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Mahdi Ali Ibrahim

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

out-patient clinic in physiotherapy department at EL KATEB Hospital

Giza, , Egypt

Countries

Egypt

Central Contacts

Mohamed Mahdy Ali, physical therapist

Role: CONTACT

M_mahdy142@yaho.com

01111153111

Facility Contacts

Mohamed Mahdy Ali, physical therapist

Role: primary

m_mahdy142@yahoo.com

01111153111

Other Identifiers

Mohamed-004968

Identifier Type: -

Identifier Source: org_study_id