f-ESWT vs Steroid Injection for Piriformis Syndrome

NCT07145554 | Completed

• 1 other identifier: GulhaneTRH
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare two treatment methods for piriformis syndrome, a condition that can cause pain in the buttock and leg. Adult patients with piriformis syndrome will take part in the trial. Participants will be randomly assigned to one of two groups. One group will receive focal extracorporeal shock wave therapy (f-ESWT), a non-invasive treatment that uses sound waves. The other group will receive a steroid injection, which is a common treatment used to reduce pain and inflammation. The goal of this study is to find out which treatment is more effective in improving symptoms of piriformis syndrome.

Conditions

Piriformis Syndrome

Outcome Measures

Primary Outcomes (2)

• Pain intensity measured by Numeric Rating Scale (NRS)

  Baseline, 1 week, 4 weeks, and 12 weeks post-treatment

• Quality of life measured by SF-36 questionnaire

  Baseline and 4 weeks post-treatment

Study Arms (2)

Shock wave group

EXPERIMENTAL

Other: Focal extracorporeal schock wave therapy

Injection group

EXPERIMENTAL

Procedure: Steroid Injection

Interventions

Steroid Injection PROCEDURE

Participants in this group will receive a single injection of corticosteroid into the piriformis muscle.

Injection group

Focal extracorporeal schock wave therapy OTHER

Participants in this group will receive a total of 5 sessions of focal extracorporeal shock wave therapy. Each session will deliver 1000 pulses per cm² to the affected piriformis muscle.

Shock wave group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with piriformis syndrome whose pain has persisted for three months or longer despite standard medical care and activity modifications.

You may not qualify if:

• Individuals with lumbar discopathy diagnosed by magnetic resonance imaging or electrodiagnostic study.
• Patients with coccyx pain.
• Individuals with mechanical or inflammatory disorders of the sacroiliac joint.
• Patients with pelvic region diseases.
• Pregnancy
• History of previous lumbar disc surgery.
• History of lumbar epidural block within the last 6 months.
• History of malignancy.
• Patients with signs of acute inflammation at the treatment site.
• Individuals with a cardiac pacemaker.

Sponsors & Collaborators

• Gulhane Training and Research Hospital: lead

Study Sites (1)

Gülhane Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Piriformis Muscle Syndrome

Interventions

Steroids

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)

Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Specialist in Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: August 28, 2025
• Study Start: October 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: April 20, 2026

Record last verified: 2025-08

Locations

TU (1)