Comparison of Ultrasound-guided Steroid Injection and Dry Needling in Piriformis Muscle Syndrome

October 18, 2023 updated by: Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Comparison of Efficacy of Ultrasound-Guided Steroid Injection and Dry Needling in Piriformis Muscle Syndrome

The aim of this study is to to compare its effectiveness ultrasound-guided steroid injection, dry needling treatments and exercises in patients diagnosed with piriformis syndrome.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Piriformis syndrome is a painful entrapment neuropathy caused by compression of the sciatic nerve under the piriformis muscle. The most common cause is myofascial pain syndrome. There is no gold standard treatment for piriformis syndrome. The main purpose of treatment methods is to reduce local pain, muscle tension and spasm. This work; it will contribute to the literature by comparing steroid, dry needling and exercise treatments in patients with piriformis syndrome.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age between 18-60,
  2. Hip pain for ≥1 month
  3. Local piriformis pain with prolonged sitting (>20 minutes) and increased sensitivity
  4. Patients with suspected piriformis syndrome based on clinical maneuvers
  5. Signing and informed consent from showing consent to participate in the study

Exclusion Criteria:

  1. Hip surgery
  2. Lumbar disc disease
  3. History of inflammatory hip disease
  4. Medical treatment for pain is started
  5. Neurological deficit
  6. Breastfeeding or pregnant
  7. Allergy to local anesthetic
  8. Use of anticoagulants
  9. Body mass index >35
  10. Active psychiatric illness
  11. Uncontrolled hypertension and diabetes mellitus disease
  12. Noncompensated chronic lung/heart/renal failure
  13. History of vascular/tumoral disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: corticosteroid group
In the steroid group, 4 mL lidocaine 2% + 1 mL betamethasone injection will be administered under ultrasound guidance and conventional treatment will be given (conventional treatment includes piriformis stretching exercises. It will be stated that patients should do 2 sets a day and each set should be 10 repetition)
Other: corticosteroid injection
In the steroid group, 4 mL lidocaine 2% + 1 mL betamethasone injection will be administered under ultrasound guidance and conventional treatment will be given (conventional treatment includes piriformis stretching exercises. It will be stated that patients should do 2 sets a day and each set should be 10 repetition)
Active Comparator: dry needling group
In the dry needling group, a total of 3 sessions of dry needling will be performed once a week using a 0.60×100 mm sterile needle under ultrasound guidance and conventional treatment will be given ((conventional treatment includes piriformis stretching exercises. It will be stated that patients should do 2 sets a day and each set should be 10 repetition)
Other: dry needling
In the dry needling group, a total of 3 sessions of dry needling will be performed once a week using a 0.60×100 mm sterile needle under ultrasound guidance and conventional treatment will be given ((conventional treatment includes piriformis stretching exercises. It will be stated that patients should do 2 sets a day and each set should be 10 repetition)
Other: control group
The conventional treatment group (control group) will be given piriformis stretching exercises including hip and knee flexion, hip abduction and external rotation in the supine position. It will be stated that patients should do 2 sets a day and each set should be 10 repetitions.
Other: exercise
The conventional treatment group (control group) will be given piriformis stretching exercises including hip and knee flexion, hip abduction and external rotation in the supine position. It will be stated that patients should do 2 sets a day and each set should be 10 repetitions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale (VAS) (Sitting)
Time Frame: at baseline and change from baseline VAS (sitting) at 4 weeks and 12 weeks
Average hip pain intensity in a sitting position over the past 24 hours, a visual analog scale. (VAS; ranging from 0 to 10, 0 = no pain and 10 = worst possible pain)
at baseline and change from baseline VAS (sitting) at 4 weeks and 12 weeks
Visual Analog Scale (VAS) (Resting)
Time Frame: at baseline and change from baseline VAS (resting) at 4 weeks and 12 weeks
Average hip pain intensity at rest over the past week is a visual analog scale. (VAS; ranging from 0 to 10, 0 = no pain and 10 = worst possible pain)
at baseline and change from baseline VAS (resting) at 4 weeks and 12 weeks
Visual Analog Scale (VAS) (Movement)
Time Frame: at baseline and change from baseline VAS (movement) at 4 weeks and 12 weeks
Average hip pain intensity during movement over the past 1 week is a visual analog scale. (VAS; ranging from 0 to 10, 0 = no pain and 10 = worst possible pain)
at baseline and change from baseline VAS (movement) at 4 weeks and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry disability index (ODI)
Time Frame: at baseline and change from baseline ODI at 4 weeks and 12 weeks
ODI includes questions regarding pain severity, sexual function, sleep quality and personal care, ability to work, sit, walk, lift, stand and travel. Total score ranges from 0-50, with higher scores indicating more injury.
at baseline and change from baseline ODI at 4 weeks and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Investigators

  • Principal Investigator: Ayşenur Şimşek Yağlıoğlu, MD, Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 28, 2023

Primary Completion (Estimated)

August 26, 2024

Study Completion (Estimated)

August 26, 2024

Study Registration Dates

First Submitted

October 18, 2023

First Submitted That Met QC Criteria

October 18, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 41

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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