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NCT Number: NCT07145554

f-ESWT vs Steroid Injection for Piriformis Syndrome

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.

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Key information

Conditions

Piriformis Syndrome 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 Sciatic Neuropathy Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gülhane Training and Research Hospital

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Steroid injection

Procedure

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

Primary outcomes

  1. Pain intensity measured by Numeric Rating Scale (NRS)

    Time frame: Baseline, 1 week, 4 weeks, and 12 weeks post-treatment

  2. Quality of life measured by SF-36 questionnaire

    Time frame: Baseline and 4 weeks post-treatment

Sponsors and collaborators

Lead sponsor

Gulhane Training and Research Hospital

Other Gov

Registry information

Official study title

Comparative Effectiveness of Focal Extracorporeal Shock Wave Therapy and Steroid Injection in Piriformis Syndrome

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 28, 2025
Registry last updated
Apr 20, 2026

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.

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