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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06095180
Other study ID # 41
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 28, 2023
Est. completion date August 26, 2024

Study information

Verified date October 2023
Source Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Contact Aysenur Simsek Yaglioglu, MD
Phone +903122912444
Email aysenursimsek33@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date August 26, 2024
Est. primary completion date August 26, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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)
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)
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analogue Scale (VAS) (Sitting) 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
Primary Visual Analog Scale (VAS) (Resting) 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
Primary Visual Analog Scale (VAS) (Movement) 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 Oswestry disability index (ODI) 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
See also
  Status Clinical Trial Phase
Completed NCT05660005 - Self Myofascial Release in Individuals With Piriformis Syndrome N/A
Completed NCT05271071 - The Importance of Gluteus Maximus Muscle in Patients With Preliminary Diagnosis of Piriformis Syndrome N/A
Completed NCT05962515 - Efficacy of Ultrasound-Guided Dry Needling Therapy and Exercise in Piriformis Muscle Syndrome
Completed NCT04600024 - Pelvic and Hip Morphometry in Piriformis Syndrome