Effect of Ultrasound-guided Piriformis Muscle Corticosteroid Injection Versus Extracorporeal Shock Wave Therapy for Piriformis Syndrome: a Randomized Control Trial

NCT04684537 | Completed

• 2 other identifiers: 20200715R2021SKHADR033
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the investigators aim to compare the effect of extracorporeal shockwave therapy with ultrasound-guided piriformis coticosteroid injection in treatment of PS.

Conditions

Piriformis Syndrome; Corticosteroid Injection; Extracorporeal Shockwave Therapy; Therapeutic Exercise

Keywords

Piriformis syndrome; ultrasound-guided intervention; corticosteroid injection; extracorporeal shockwave therapy; therapeutic exercise

Outcome Measures

Primary Outcomes (2)

• The pain visual analog scale (VAS)

  It measures severity of pain. It is performed with a 100-mm horizontal line. The end of the left side is defined as no pain, and the end of the right side as the worst pain. Participants are requested to report the severity of buttock pain in recent one week.

  change between baseline and at 1 week, 5 weeks after the beginning of the treatment.

• Oswestry Disability Index (ODI)

  ODI score is used for disability evaluation. It is a self-reported questionnaire with range 0-100. It has 10 questions with an minimal clinical important difference (MCID) of 10 points, with higher scores indicating more disability. The questions include pain intensity, sleep quality, and ability to perform personal care, work, sit, walk, lift, stand, and travel.

  change between baseline and at 1 week, 5 weeks after the beginning of the treatment.

Secondary Outcomes (2)

• hip range of motion

  change between baseline and at 1 week, 5 weeks after the beginning of the treatment.

• change of pressure pain threshold

  change between baseline and at 1 week, 5 weeks after the beginning of the treatment.

Other Outcomes (1)

• Patient's self evaluation

  change between baseline and at 1 week, 5 weeks after the beginning of the treatment.

Study Arms (2)

Shockwave group

ACTIVE COMPARATOR

each subject will receive extracorporeal shockwave therapy

Procedure: Extracorporeal shockwave therapy (ESWT)

Injection group

ACTIVE COMPARATOR

each subject will receive ultrasound-guided piriformis corticosteroid injection

Procedure: Ultrasound-guided piriformis steroid injection

Interventions

Extracorporeal shockwave therapy (ESWT) PROCEDURE

The therapy will be performed with the focused piezoelectric shockwave (F10G4 Richard Wolf GmbH, Germany). The patient will be kept in the hip flexion, adduction and internal rotation position. After sonography-guided localization of the affected muscle and identification of the trigger point by the participant, ultrasound gel is applied to the skin and the applicator couple is placed with an impulse energy flux density of 0.456-0.882 mJ/mm2 for 3500 impulses.

Shockwave group

Ultrasound-guided piriformis steroid injection PROCEDURE

all the participants will receive ultrasound-guided piriformis injection with 10 mg triamcinolone and 1 c.c. 1% lidocaine for one time.

Injection group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 20 to 80
• Unilateral buttock involvement without leg pain or paresthesia
• Duration of symptoms ≥1 month
• Positive trigger point or taut band at piriformis muscle, confirmed by palpation and ultrasound examination
• Positive FAIR (flexion, adduction, internal rotation) test
• Positive piriformis resistive test (patient actively abducts and/or externally rotates the hip while the examiner resists these movements

You may not qualify if:

• Having received hip, pelvis, or lumbar spine surgery
• Low back pain or buttock pain due to lumbosacral spine, hip or pelvis lesion other than piriformis syndrome
• Having received shock wave therapy or corticosteroid injection for buttock pain within the past one month
• Neurologic deficit in in the lower limbs
• History of drug allergy to local anesthetics or corticosteroids
• Pregnancy

Sponsors & Collaborators

• Shin Kong Wu Ho-Su Memorial Hospital: lead

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

Location

Related Publications (1)

• Fu YS, Shih KS, Lin YT, Hsieh LF, Liu YF, Chen YR. Efficacy of ultrasound-guided piriformis muscle corticosteroid injection versus extracorporeal shockwave therapy in patients with piriformis syndrome: A randomized controlled trial. J Formos Med Assoc. 2025 Feb 27:S0929-6646(25)00036-1. doi: 10.1016/j.jfma.2025.01.020. Online ahead of print.

  PMID: 40016058 DERIVED

MeSH Terms

Conditions

Piriformis Muscle Syndrome

Interventions

Extracorporeal Shockwave Therapy

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

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Lin-Fen Hsieh

  Shin Kong Wu Ho-Su Memorial Hospital

  PRINCIPAL INVESTIGATOR

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
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: December 24, 2020
• Study Start: January 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: July 12, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)