Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06762197

Radial Shockwave Versus Low Level Laser Therapy in 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Extracorporeal Shock Wave Low Level Laser Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Pelvic Pain Peripheral Nervous System Diseases Piriformis Muscle Syndrome Radial Shock Wave Sciatic Neuropathy Signs and Symptoms

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

out-patient clinic in physiotherapy department at EL KATEB Hospital

Giza, Egypt

Location contact

Mohamed Mahdy Ali, physical therapist

CONTACT

[email protected]

01111153111

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

conventional treatment

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

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

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.

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. assessing the change of functional status

    Time frame: 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.

  2. assessing the change of range of motion of lower limb

    Time frame: 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.

  3. assessing the change of piriformis muscle thickness

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Mahdy Ali, physical therapist

CONTACT

[email protected]

01111153111

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 7, 2025
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.