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

Primary Purpose

Piriformis Syndrome, Corticosteroid Injection, Extracorporeal Shockwave Therapy

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Extracorporeal shockwave therapy (ESWT)
Ultrasound-guided piriformis steroid injection
Sponsored by
Shin Kong Wu Ho-Su Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Piriformis Syndrome focused on measuring Piriformis syndrome, ultrasound-guided intervention, corticosteroid injection, extracorporeal shockwave therapy, therapeutic exercise

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shin Kong Wu Ho-Su Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Shockwave group

Injection group

Arm Description

each subject will receive extracorporeal shockwave therapy

each subject will receive ultrasound-guided piriformis corticosteroid injection

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

hip range of motion
Internal and external rotation of the hip on the affected side will be measured with a goniometer by the study assistant. The measurement will be performed in the supine position according the standard procedure.
change of pressure pain threshold
It is defined as the amount of pressure needed to shift local sensation from pressure to pain. This is measured with a digital algometer and has been shown to have excellent intrarater reliability in the gluteal region (ICC = .90), with a minimal detectable change of 3.1 N/cm2. The digital algometer, made up of a 1-cm-wide disk, will be placed at the tender point between the ischial tuberosity and the greater trochanter while the patient is lying prone. The algometer's pressure will be increased gradually (with a speed approximately 1 N/cm2 per second) until the participant reports pain. The average value of three repeated measurements is recorded.

Full Information

First Posted
December 21, 2020
Last Updated
July 10, 2023
Sponsor
Shin Kong Wu Ho-Su Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04684537
Brief Title
Effect of Ultrasound-guided Piriformis Muscle Corticosteroid Injection Versus Extracorporeal Shock Wave Therapy for Piriformis Syndrome: a Randomized Control Trial
Official Title
Effect of Ultrasound-guided Piriformis Muscle Corticosteroid Injection Versus Extracorporeal Shock Wave Therapy for Piriformis Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shin Kong Wu Ho-Su Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Piriformis Syndrome, Corticosteroid Injection, Extracorporeal Shockwave Therapy, Therapeutic Exercise
Keywords
Piriformis syndrome, ultrasound-guided intervention, corticosteroid injection, extracorporeal shockwave therapy, therapeutic exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Shockwave group
Arm Type
Active Comparator
Arm Description
each subject will receive extracorporeal shockwave therapy
Arm Title
Injection group
Arm Type
Active Comparator
Arm Description
each subject will receive ultrasound-guided piriformis corticosteroid injection
Intervention Type
Procedure
Intervention Name(s)
Extracorporeal shockwave therapy (ESWT)
Intervention Description
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
Intervention Name(s)
Ultrasound-guided piriformis steroid injection
Intervention Description
all the participants will receive ultrasound-guided piriformis injection with 10 mg triamcinolone and 1 c.c. 1% lidocaine for one time.
Primary Outcome Measure Information:
Title
The pain visual analog scale (VAS)
Description
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.
Time Frame
change between baseline and at 1 week, 5 weeks after the beginning of the treatment.
Title
Oswestry Disability Index (ODI)
Description
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.
Time Frame
change between baseline and at 1 week, 5 weeks after the beginning of the treatment.
Secondary Outcome Measure Information:
Title
hip range of motion
Description
Internal and external rotation of the hip on the affected side will be measured with a goniometer by the study assistant. The measurement will be performed in the supine position according the standard procedure.
Time Frame
change between baseline and at 1 week, 5 weeks after the beginning of the treatment.
Title
change of pressure pain threshold
Description
It is defined as the amount of pressure needed to shift local sensation from pressure to pain. This is measured with a digital algometer and has been shown to have excellent intrarater reliability in the gluteal region (ICC = .90), with a minimal detectable change of 3.1 N/cm2. The digital algometer, made up of a 1-cm-wide disk, will be placed at the tender point between the ischial tuberosity and the greater trochanter while the patient is lying prone. The algometer's pressure will be increased gradually (with a speed approximately 1 N/cm2 per second) until the participant reports pain. The average value of three repeated measurements is recorded.
Time Frame
change between baseline and at 1 week, 5 weeks after the beginning of the treatment.
Other Pre-specified Outcome Measures:
Title
Patient's self evaluation
Description
At 1-week and 5-week evaluations, patients are asked to report treatment effect by themselves as the following five grades: 5. Complete relief of symptoms; 4. Much improved, no need for further treatment; 3. Mildly improved, need further treatment; 2.No improvement; 1. Worse.
Time Frame
change between baseline and at 1 week, 5 weeks after the beginning of the treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin-Fen Hsieh
Organizational Affiliation
Shin Kong Wu Ho-Su Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shin Kong Wu Ho-Su Memorial Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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