f-ESWT vs Steroid Injection for Piriformis Syndrome | NCT07145554

Studies
f-ESWT vs Steroid Injection for Piriformis Syndrome

NCT07145554

Sponsor

Gulhane Training and Research Hospital

Status

Completed

Last Update Posted

Apr 20, 2026Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Piriformis Syndrome

Interventions

Focal extracorporeal schock wave therapy
Steroid Injection

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2025Actual

Primary Completion Date

Feb 1, 2026Actual

Completion Date

Mar 1, 2026Actual

First Submitted Date

Aug 21, 2025

First Submission Date that Met QC Criteria

Aug 21, 2025

First Posted Date

Aug 28, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2026

Last Update Posted Date

Apr 20, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hilal Busra Aycicek, MD, Specialist in Physical Medicine and Rehabilitation, Gulhane Training and Research HospitalPrincipal Investigator

Lead Sponsor

Gulhane Training and Research HospitalOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Shock wave group	Experimental		Other: Focal extracorporeal schock wave therapy
Injection group	Experimental		Procedure: Steroid Injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gülhane Training and Research Hospital		Ankara			Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D055958	Piriformis Muscle Syndrome

Ancestor Terms

ID	Term
D020426	Sciatic Neuropathy
D020422	Mononeuropathies
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013256	Steroids

Ancestor Terms

ID	Term
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided