Piriformis Syndrome; Extracorporeal Shock Wave Therapy and Dry Needling

Comparison of the Efficacy of ESWT and Dry Needling Treatments in the Management of Piriformis Syndrome; A Randomized Study

This study is being conducted on patients with piriformis syndrome. Patients are divided into two groups by list randomization method: Extracorporeal shock wave therapy (ESWT) group and Dry neddling (DN) group. Both groups of patients agreed to perform basic stretching exercises. The ESWT group received 3 sessions of radial ESWT, 1 session per week. The DN group received 3 sessions of ultrasound-guided needling, 1 session per week. Clinical evaluations of the participants were performed at the beginning of treatment, 1 month, and 3 months after treatment.

Study Overview

• Status: Completed
• Conditions: Piriformis Syndrome; Extracorporeal Shock Wave Therapy
• Intervention / Treatment: Other: ESWT+stretching exercises; Other: Dry needling+stretching exercises

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Burak Tayyip Dede

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• >18 years
• Complaint for more than 3 months

Exclusion Criteria:

• disc pathologies according to radiological imaging
• hip joint and soft tissue pathologies
• recent history of trauma, history of surgery in the lumbar and hip region
• history of rheumatologic disease
• history of polyneuropathy
• history of sciatic nerve injury
• history of malignancy
• opioid analgesia or corticosteroid intervention for pain in the last month
• patients receive another treatment during the study
• Having a contraindication for DN treatment or ESWT treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ESWT group; Patients in this group received three sessions of ESWT at an energy density of 4 bars and a frequency of 2,000 shocks/min at 5 Hz for three weeks, each session once a week.	Other: ESWT+stretching exercises; Participants in this group will receive ESWT treatment
Active Comparator: Dry needling; The piriformis muscle of the patients in the group will be dry needled with 0.6*80 mm acupuncture needles under ultrasound guidance for 3 sessions at one week intervals.	Other: Dry needling+stretching exercises; Participants in this group will receive Dry needling treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analog scale (VAS) score	Pain was evaluated with a Visual analog scale (VAS) score	7 months
Lower extremity functiunal scale (LEFS)	Pain was evaluated with a Lower extremity functiunal scale (LEFS (minimum=0, maximum=80)) The higher the score, the better the result	7 months
Oswestry disability index (ODI)	Pain was evaluated with a Oswestry disability index (ODI (minimum=0, maximum=60))The lower the score the better the result	7 months

Collaborators and Investigators

• Sponsor: Istanbul Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2024
• Primary Completion (Actual): August 23, 2024
• Study Completion (Actual): August 23, 2024

Study Registration Dates

• First Submitted: July 27, 2024
• First Submitted That Met QC Criteria: July 27, 2024
• First Posted (Actual): July 31, 2024

Study Record Updates

• Last Update Posted (Actual): August 30, 2024
• Last Update Submitted That Met QC Criteria: August 28, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Dry Needling; ESWT; Piriformis Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Pain; Neurologic Manifestations; Disease; Neuromuscular Diseases; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuralgia; Nerve Compression Syndromes; Pelvic Pain; Syndrome; Piriformis Muscle Syndrome
• Other Study ID Numbers: 22/12/2023; 2011-KAEK-50;347

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No