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

Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06095180
Collaborator
(none)
60
3
8.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: corticosteroid injection
  • Other: dry needling
  • Other: exercise
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
Outcome measures will be evaluated by an independent physiatrist, blinded for the assigned treatment.
Primary Purpose:
Treatment
Official Title:
Comparison of Efficacy of Ultrasound-Guided Steroid Injection and Dry Needling in Piriformis Muscle Syndrome
Anticipated Study Start Date :
Nov 28, 2023
Anticipated Primary Completion Date :
Aug 26, 2024
Anticipated Study Completion Date :
Aug 26, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Visual Analogue Scale (VAS) (Sitting) [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)

  2. Visual Analog Scale (VAS) (Resting) [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)

  3. Visual Analog Scale (VAS) (Movement) [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)

Secondary Outcome Measures

  1. Oswestry disability index (ODI) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yasin Demir, Associate Professor, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
ClinicalTrials.gov Identifier:
NCT06095180
Other Study ID Numbers:
  • 41
First Posted:
Oct 23, 2023
Last Update Posted:
Oct 23, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yasin Demir, Associate Professor, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 23, 2023