Piriformis Syndrome Clinical Trial
Official title:
Effect of Ultrasound-guided Piriformis Muscle Corticosteroid Injection Versus Extracorporeal Shock Wave Therapy for Piriformis Syndrome
Verified date | July 2023 |
Source | Shin Kong Wu Ho-Su Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this study, the investigators aim to compare the effect of extracorporeal shockwave therapy with ultrasound-guided piriformis coticosteroid injection in treatment of PS.
Status | Completed |
Enrollment | 70 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | Shin Kong Wu Ho-Su Memorial Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Shin Kong Wu Ho-Su Memorial Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Patient's self evaluation | 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. | change between baseline and at 1 week, 5 weeks after the beginning of the treatment. | |
Primary | 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. | |
Primary | 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 | 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 between baseline and at 1 week, 5 weeks after the beginning of the treatment. | |
Secondary | 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. | change between baseline and at 1 week, 5 weeks after the beginning of the treatment. |
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