Piriformis SyndromeNCT04684537
Effect of Ultrasound-guided Piriformis Muscle Corticosteroid Injection Versus Extracorporeal Shock Wave Therapy for Piriformis Syndrome: a Randomized Control Trial
A study testing Extracorporeal shockwave therapy (ESWT) and Ultrasound-guided piriformis steroid injection in people with Piriformis Syndrome and Corticosteroid Injection, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Piriformis Syndrome, Corticosteroid Injection, Extracorporeal Shockwave Therapy
- What is being tested?
- Extracorporeal shockwave therapy (ESWT) and Ultrasound-guided piriformis steroid injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Ultrasound-guided Piriformis Muscle Corticosteroid Injection Versus Extracorporeal Shock Wave Therapy for Piriformis Syndrome
In this study, the investigators aim to compare the effect of extracorporeal shockwave therapy with ultrasound-guided piriformis coticosteroid injection in treatment of PS.
Read the 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).
- Conditions
- Piriformis Syndrome, Corticosteroid Injection, Extracorporeal Shockwave Therapy, Therapeutic Exercise
- Being tested
- Extracorporeal shockwave therapy (ESWT), Ultrasound-guided piriformis steroid injection
- Keywords
- Piriformis syndrome, ultrasound-guided intervention, corticosteroid injection, extracorporeal shockwave therapy, therapeutic exercise
- Medical subject headings
- Piriformis Muscle Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal shockwave therapy (ESWT)Procedure or surgery
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.
Ultrasound-guided piriformis steroid injectionProcedure or surgery
all the participants will receive ultrasound-guided piriformis injection with 10 mg triamcinolone and 1 c.c. 1% lidocaine for one time.
| Study group | Role | What they receive |
|---|---|---|
| Shockwave group | Active comparator | each subject will receive extracorporeal shockwave therapy Receives: Procedure: Extracorporeal shockwave therapy (ESWT) |
| Injection group | Active comparator | each subject will receive ultrasound-guided piriformis corticosteroid injection Receives: Procedure: Ultrasound-guided piriformis steroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: change between baseline and at 1 week, 5 weeks after the beginning of the treatment.
Secondary outcomes (2)
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.
Measured: change between baseline and at 1 week, 5 weeks after the beginning of the treatment.
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.
Measured: change between baseline and at 1 week, 5 weeks after the beginning of the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start1 Jan 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Piriformis SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin-Fen Hsieh, Shin Kong Wu Ho-Su Memorial Hospital
- Investigators
- Lin-Fen Hsieh, Principal investigator, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684537
- Sponsor's protocol ID
- 20200715R
- Other IDs
- 2021SKHADR033
- Status last verified
- Jul 2023
- First submitted
- 21 Dec 2020
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. 2026 Apr;125(4):391-397. doi: 10.1016/j.jfma.2025.01.020. Epub 2025 Feb 27.
PubMed 40016058
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultrasound-guided Piriformis Muscle Corticosteroid Injection Versus Extracorporeal Shock Wave Therapy for Piriformis Syndrome
- ClinicalTrials.gov ID
- NCT04684537
- Acronym / sponsor ID
- 20200715R
- Conditions
- Piriformis Syndrome, Corticosteroid Injection, Extracorporeal Shockwave Therapy, Therapeutic Exercise
- Keywords
- Piriformis syndrome, ultrasound-guided intervention, corticosteroid injection, extracorporeal shockwave therapy, therapeutic exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 24 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shockwave group | Active comparator | Procedure: Extracorporeal shockwave therapy (ESWT)each subject will receive extracorporeal shockwave therapy |
| Injection group | Active comparator | Procedure: Ultrasound-guided piriformis steroid injectioneach subject will receive ultrasound-guided piriformis corticosteroid injection |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Shockwave group |
| Ultrasound-guided piriformis steroid injectionall the participants will receive ultrasound-guided piriformis injection with 10 mg triamcinolone and 1 c.c. 1% lidocaine for one time. | Procedure or surgery | Injection group |
Primary outcome
The pain visual analog scale (VAS)
Time frame: change between baseline and at 1 week, 5 weeks after the beginning of the treatment.
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)
Time frame: change between baseline and at 1 week, 5 weeks after the beginning of the treatment.
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.
2 secondary outcomes
hip range of motion
Time frame: change between baseline and at 1 week, 5 weeks after the beginning of the treatment.
change of pressure pain threshold
Time frame: change between baseline and at 1 week, 5 weeks after the beginning of the treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Derived from this study: PubMed 40016058Fu 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. 2026 Apr;125(4):391-397. doi: 10.1016/j.jfma.2025.01.020. Epub 2025 Feb 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lin-Fen Hsieh principal investigator
Shin Kong Wu Ho-Su Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal shockwave therapy (ESWT) and Ultrasound-guided piriformis steroid injection in people with Piriformis Syndrome and Corticosteroid Injection, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The pain visual analog scale (VAS) (time frame: change between baseline and at 1 week, 5 weeks after the beginning of the treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04684537, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.