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

NCT06762197 | Not Yet Recruiting

• 1 other identifier: Mohamed-004968
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Assessing the change of body mass index

  Weight and height Scale will be used to measure body mass index

  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.

  at baseline and after 6 weeks

Secondary Outcomes (3)

• assessing the change of functional status

  at baseline and after 6 weeks

• assessing the change of range of motion of lower limb

  at baseline and after 6 weeks

• assessing the change of piriformis muscle thickness

  at baseline and after 6 weeks

Study Arms (3)

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).

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).

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).

Other: Conventional treatment; Device: low level laser therapy

Interventions

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.

Radial Extracorporeal shock wave; conventional program; low level laser therapy

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.

Radial Extracorporeal shock wave

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.

low level laser therapy

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

out-patient clinic in physiotherapy department at EL KATEB Hospital

Giza, Egypt

Location

MeSH Terms

Conditions

Piriformis Muscle Syndrome

Interventions

Extracorporeal Shockwave Therapy; Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pelvic Pain

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation; Laser Therapy; Phototherapy

Central Study Contacts

Mohamed Mahdy Ali, physical therapist

CONTACT

01111153111; M_mahdy142@yaho.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: January 1, 2025
• First Posted: January 7, 2025
• Study Start: January 1, 2025
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)