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

NCT06095180 | Unknown

• 1 other identifier: 41
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Piriformis Muscle Syndrome

Keywords

piriformis syndrome; steroid injection; dry needling; exercise

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Oswestry disability index (ODI)

  at baseline and change from baseline ODI at 4 weeks and 12 weeks

Study Arms (3)

corticosteroid group

ACTIVE COMPARATOR

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

dry needling group

ACTIVE COMPARATOR

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

control group

OTHER

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

Interventions

corticosteroid injection OTHER

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)

corticosteroid group

dry needling OTHER

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)

dry needling group

exercise OTHER

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.

control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Hip surgery
• Lumbar disc disease
• History of inflammatory hip disease
• Medical treatment for pain is started
• Neurological deficit
• Breastfeeding or pregnant
• Allergy to local anesthetic
• Use of anticoagulants
• Body mass index \>35
• Active psychiatric illness
• Uncontrolled hypertension and diabetes mellitus disease
• Noncompensated chronic lung/heart/renal failure
• History of vascular/tumoral disease

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

MeSH Terms

Conditions

Piriformis Muscle Syndrome; Motor Activity

Interventions

Adrenal Cortex Hormones; Dry Needling; Exercise

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; Behavior

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ayşenur Şimşek Yağlıoğlu, MD

  Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayşenur Şimşek Yağlıoğlu, MD

CONTACT

+903122912444; aysenursimsek33@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome measures will be evaluated by an independent physiatrist, blinded for the assigned treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 23, 2023
• Study Start: November 28, 2023
• Primary Completion: August 26, 2024
• Study Completion: August 26, 2024
• Last Updated: October 23, 2023

Record last verified: 2023-10