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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-12-31

Brief Summary

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

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Detailed Description

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Piriformis syndrome (PS) is one of the common etiology of low back pain. The cause of PS is due to myofascial syndrome of piriformis muscle, leading to piriformis muscle spasm, string-like taut band, and trigger point. Consequently, it may compresses the sciatic nerve which arise from sciatic notch and passes under the piriformis muscle. Conservative treatment of PS includes therapeutic exercise, diathermy, and local steroid injection. Among them, as radiology techniques advance, ultrasound-guided piriformis injection becomes popular for diagnosis block and treatment. Nowadays, extracorporeal shockwave therapy has widely applied in musculoskeletal disease such as plantar fasciitis, tennis elbow, and calcific tendinitis of the shoulder. However, to the investigators best knowledge, there is no study comparing the therapeutic effect between local steroid injection and shockwave. In this study, the investigators aim to compare the effect of extracorporeal shockwave therapy with ultrasound-guided piriformis corticosteroid injection.

This is a randomized controlled trial. 70 participants will be randomly divided into shockwave group and injection group. The participant in the shockwave group will receive one time extracorporeal shockwave therapy, and injection group will receive one time ultrasound-guided piriformis muscle corticosteroid injection. After the intervention, participant in both groups will receive home-based stretch exercise. Evaluation will be performed at baseline, 1 week, and 5 weeks after intervention. Outcome measures include the pain visual analog scale (VAS), hip range of motion, change of pressure pain threshold, and Oswestry Disability Index (ODI).

Conditions

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Piriformis Syndrome Corticosteroid Injection Extracorporeal Shockwave Therapy Therapeutic Exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Shockwave group

each subject will receive extracorporeal shockwave therapy

Group Type ACTIVE_COMPARATOR

Extracorporeal shockwave therapy (ESWT)

Intervention Type 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.

Injection group

each subject will receive ultrasound-guided piriformis corticosteroid injection

Group Type ACTIVE_COMPARATOR

Ultrasound-guided piriformis steroid injection

Intervention Type PROCEDURE

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

Interventions

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Extracorporeal shockwave therapy (ESWT)

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.

Intervention Type PROCEDURE

Ultrasound-guided piriformis steroid injection

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No