Effect of Ultrasound-guided Piriformis Muscle Corticosteroid Injection Versus Extracorporeal Shock Wave Therapy for Piriformis Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Oswestry Disability Index (ODI)
研究概览
简要总结
In this study, the investigators aim to compare the effect of extracorporeal shockwave therapy with ultrasound-guided piriformis coticosteroid injection in treatment of PS.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Oswestry Disability Index (ODI)
时间窗: 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.
The pain visual analog scale (VAS)
时间窗: 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.
次要结局
- 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.)
研究者
Lin-Fen Hsieh
Principal Investigator
Shin Kong Wu Ho-Su Memorial Hospital