ACTRN12615001225505尚未招募未知
Endoscopic iliotibial band release and trochanteric bursectomy with and without adjuvant platelet-rich plasma for recalcitrant greater trochanteric pain syndrome, outcomes on pain and physical function: a single blinded randomised controlled trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 128
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Adult > 18yrs old
- •Greater trochanteric pain syndrome (GTPS) diagnosed clinically by principal investigator according to following criteria (must have number 1+2 and one of 3-5):
- •1. History of aching pain on lateral aspect of hip
- •2. Distinct tenderness about the greater trochanter
- •3. Pain at extremes of hip rotation
- •4. Pain on strong contraction of hip abductors
- •5. Pseudoradiculopathy down thigh
- •Have had minimum 6 months of symptoms
- •Failed minimum of 6 months of non-operative management (including rest, physiotherapy and corticosteroid injection)
- •Undergone minimum of 1 previous corticosteroid injection into area about greater trochanter
- •Have optimised medical management (control of medical comorbidities, on appropriate analgesics as required)
- •Have ultrasound or MRI showing signs of GTPS (gluteal tendinopathy and/or bursitis) without a full thickness gluteal muscle or tendon tear
- •Have hip X-ray showing no or mild arthritis (Tonnis grade 0 or 1)
排除标准
- •Any previous surgery on affected hip (e.g. arthroscopy, total hip replacement)
- •Previous platelet-rich plasma (PRP) injection into affected hip region
- •Other pathology involving affected hip that can mimic pain of GTPS (e.g. hip arthritis grade 2-3, labral tear, femoroacetabular impingement, ligamentum teres tear, lumbar radiculopathy, hip dysplasia, fibromyalgia
- •Full thickness gluteal muscle/tendon tear on affected side
- •Does not speak English
- •Unable to complete questionnaires due to mental/physical comorbidities
- •Person is known to have a psychological, developmental, physical, emotional or social disorder that may interfere with compliance with study requirements
- •Conditions where PRP is contraindicated and patient will be excluded:
- •1. History of severe uncontrolled diabetes mellitus
- •2. Platelet abnormality or platelet count < 100 x 109 /L
- •3. Haematological disorder
- •4. Serum haemoglobin < 11 g/dL
- •5. Use of systemic cortisone
- •6. Use of any anticoagulant
- •7. Evidence of gangrene/ulcers or peripheral vascular disease
- •8. History of hepatic or renal impairment or dialysis
- •9. History of alcohol or drug abuse
- •10. Person has a religious or cultural conflict with the use of platelet gel treatment or blood products
- •11. Has inadequate venous access for blood draw
- •12. Is currently receiving or has received radiation or chemotherapy within the last 3 months prior to the study
- •13. Pregnant women, or women who are lactating or planning pregnancy during the course of the study
研究者
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