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

Not Applicable

Not yet recruiting

• Conditions: Extracorporeal Shock Wave; Radial Shock Wave; Low Level Laser; Piriformis Muscle Syndrome

• Registration Number: NCT06762197
• Lead Sponsor: Cairo University

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.

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-01
• Study First Submitted: 2025-01-01
• Study First Submitted QC: 2025-01-01
• Last Update Submitted: 2025-01-01
• Study First Posted: 2025-01-07
• Last Update Posted: 2025-01-07
• Primary Completion: 2025-03-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 63

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assessing the change of body mass index	at baseline and after 6 weeks	Weight and height Scale will be used to measure body mass index
assessing the change of pain intensity	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.

Secondary Outcome Measures

Name	Time	Method
assessing the change of functional status	at baseline and after 6 weeks	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.
assessing the change of range of motion of lower limb	at baseline and after 6 weeks	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.
assessing the change of piriformis muscle thickness	at baseline and after 6 weeks	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.

Trial Locations

Locations (1)

out-patient clinic in physiotherapy department at EL KATEB Hospital; 🇪🇬 Giza, Egypt