Use of Cooled Radiofrequency for the Treatment of Hip Pain Associated With OA of the Hip Compared to Intra-articular Steroid Injections
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in visual analog scale (VAS) pain by 1.5 points
研究概览
简要总结
This will be a multi-center, prospective, single-blinded randomized clinical trial to investigate the effectiveness of using cooled radiofrequency ablation (CRFA) for the treatment of osteoarthritis (OA) hip pain and function in subjects treated with CRFA compared with standard of care intra-articular steroid injections
详细描述
This prospective, single-blinded randomized clinical trial investigates the effectiveness of using cooled radiofrequency ablation (CRFA) for the treatment of osteoarthritis (OA) hip pain and function compared with standard of care intra-articular steroid injections. This study also aims to determine if CRFA is more effective at decreasing hip pain from OA after treatment and improving hip function in terms of range of motion and walking mobility when compared to corticosteroid hip injections. The primary outcome of interest is a decrease in visual analog scale (VAS) pain as reported following treatment with either a hip injection or following RFA treatment for patients who are not candidates for total hip arthroplasty (THA). Secondary objectives include physical performance at each follow-up time point including range of motion and 50 ft walk test, Hip disability and Osteoarthritis Outcome Score (HOOS) and PROMIS questionnaires at each follow-up time point, patient satisfaction at 24 weeks after treatment, and the number of subjects requesting additional treatment for hip pain during the follow-up period.
The assessments will be conducted by comparing patients with pain from hip OA who get CRFA treatment versus patients who get a hip corticosteroid injection. The research hypothesis is that CRFA will lead to a greater reduction in pain up to 24 weeks +/- 2 weeks following treatment compared to a hip corticosteroid injection. This may result in patients having greater relief of their hip pain which may improve joint function and quality of life with the availability of a new alternative to treat hip OA.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects older than 18 years of age presenting with radiographic evidence of hip OA and demonstrating hip pain for at least 30 days (Radiographic evidence of hip OA is defined as Kellegran-Lawrence grade 2-4)
- •Relief of patients' typical hip pain symptoms after a positive diagnostic nerve block test and eligibility for cooled radiofrequency ablation of these same nerves
排除标准
- •Patients who have received any steroid injection in hip within the last 90 days
- •Individuals who cannot consent for themselves such as children and subjects with impaired decision making
- •Local infection at injection site or active systemic infection
- •Anticoagulation status with inability to discontinue medication for appropriate duration for nerve blocks and CRFA given proximity to major artery. (No anticoagulation contraindications for joint injection)
- •Automated implantable cardioverter defibrillator with inability to utilize magnet for CRFA per treating cardiologist
- •Body habitus does not allow for placement of longest needles and electrodes (approximately 15cm) to successfully administer treatment
- •Allergy or severe renal impairment precluding iodinated contrast or magnevist injection despite standard premedication protocol
- •Negative diagnostic nerve block tests
研究组 & 干预措施
Intra-articular corticosteroid injections
The hip and groin areas will be prepped and draped in the usual sterile fashion with ChloraPrep. Preprocedural vital signs will be performed and will be in the nursing chart for review. Radiology guidance will be used to guide needle placement within the affected hip to administer lidocaine and a corticosteroid intra-articularly.
干预措施: intra-articular corticosteroid injection (Drug)
Cooled radiofrequency ablation
The hip and groin areas will be prepped and draped in the usual sterile fashion with ChloraPrep. Preprocedural vital signs will be performed and will be in the nursing chart for review. The HALYARD* COOLIEF* SINERGY* Cooled Radiofrequency Probe (sterile, single use) is inserted through a COOLIEF* SINERGY* Introducer used with fluoroscopy guidance in the AP view to visualize the hip joint and sensory nerve areas over the acetabulum (femoral) and ischium (obturator) where the cooled radiofrequency ablation will be applied to create a focal thermal lesion to encompass and denervate the targeted nerves.
干预措施: Cooled RFA treatment with COOLIEF* device (Procedure)
结局指标
主要结局
Change in visual analog scale (VAS) pain by 1.5 points
时间窗: up to 24 weeks +/- 2 weeks after either a hip injection or following CRFA treatment for hip OA pain.
VAS Pain score is is scored using a ruler where the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in post-surgical patients who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)
次要结局
- Physical performance (hip range of motion)(4 weeks +/- 2 weeks, 8 weeks +/- 2 weeks, 12 weeks +/- 2 weeks, and 24 weeks +/- 2 weeks following treatment)
- Physical performance (50 ft walk test)(4 weeks +/- 2 weeks, 8 weeks +/- 2 weeks, 12 weeks +/- 2 weeks, and 24 weeks +/- 2 weeks following treatment)
- Number of subjects requesting additional treatment for hip pain during the follow-up period(12 weeks after study treatment)
- visual analog scale (VAS) pain scores at each follow-up time point(4 weeks +/- 2 weeks, 8 weeks +/- 2 weeks, 12 weeks +/- 2 weeks, and 24 weeks +/- 2 weeks following treatment, and 6 months and 1 year after the procedure)
- Hip disability and Osteoarthritis Outcome Score (HOOS)(4 weeks +/- 2 weeks, 8 weeks +/- 2 weeks, 12 weeks +/- 2 weeks, and 24 weeks +/- 2 weeks following treatment, and 6 months and 1 year after the procedure)
- Patient-Reported Outcomes Measurement Information System (PROMIS)(4 weeks +/- 2 weeks, 8 weeks +/- 2 weeks, 12 weeks +/- 2 weeks, and 24 weeks +/- 2 weeks following treatment, and 6 months and 1 year after the procedure)
- Patient satisfaction with the study treatment via Likert scale questionnaire(24 weeks +/- 2 weeks after study treatment)
研究者
Antonia Faustina Chen
Associate Professor of Orthopedic Surgery
Brigham and Women's Hospital