Piriformis Syndrome; Extracorporeal Shock Wave Therapy and Dry Needling

NCT06530862 | Completed

• 1 other identifier: 22/12/2023; 2011-KAEK-50;347
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Piriformis Syndrome; Extracorporeal Shock Wave Therapy

Keywords

ESWT; Dry Needling; Piriformis Syndrome

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

ESWT group

ACTIVE COMPARATOR

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

Dry needling

ACTIVE COMPARATOR

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

Interventions

ESWT+stretching exercises OTHER

Participants in this group will receive ESWT treatment

ESWT group

Dry needling+stretching exercises OTHER

Participants in this group will receive Dry needling treatment

Dry needling

Eligibility Criteria

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

You may qualify if:

• \>18 years
• Complaint for more than 3 months

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Training and Research Hospital: lead

Study Sites (1)

Burak Tayyip Dede

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Piriformis Muscle Syndrome

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: Participants will be randomly divided into 2 groups and will be treated with ESWT or Dry needling

Study Record Dates

• First Submitted: July 27, 2024
• First Posted: July 31, 2024
• Study Start: February 3, 2024
• Primary Completion: August 23, 2024
• Study Completion: August 23, 2024
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)