Prairie Renal Denervation Study: Renal Denervation (RDN) for Management of Patients With Loin Pain Hematuria Syndrome (LPHS)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Assess the proportion of participants undergo procedures (treatment or sham) within 6 months
研究概览
简要总结
Loin Pain Hematuria Syndrome (LPHS) is a poorly understood, painful and incapacitating condition that typically afflicts young women and was first described in 1967. Currently, the treatment for LPHS is opioid prescription and in some extreme cases, surgical denervation of the nociceptive impulses with renal auto transplantation and auto nephrectomy.
Radiofrequency nerve ablation is a minimally invasive alternative to opiate therapy, auto-transplantation and nephrectomy in LPHS. In the investigators' previous exploratory pre/post single centre studies, the investigators showed promising results with regards to pain relief, mood, disability and quality of life post procedure. As these initial studies were neither blinded nor randomized, improvements in pain and quality of life scores owing to a placebo effect cannot be ruled out ; hence, to rule out any cause-effect relation between treatment and outcome, selection-bias, influences the investigators intend to conduct a double-blinded, parallel group, sham-controlled, randomized controlled trial (RCT). The present study is designed to assess the feasibility of conducting a large scale randomized control trial.
Study Hypothesis: In the present study the investigators hypothesize that the recruitment, intervention, measurement and trial procedures will be feasible and acceptable, thus allowing to proceed with a full randomized control trial
详细描述
Research Design and Methods
This study is a double-blinded, parallel group, sham-controlled, randomized control, partial crossover feasibility trial. This feasibility trial is a part of a larger clinical to trial to assess both statistical and clinical significance of renal denervation treatment in LPHS. This trial will involve 10 Saskatchewan -based patients for whom travel will be covered to and from Regina. These patients will be randomized to either receive the treatment procedure or the sham procedure.
To assess the feasibility measure, the QuinteT recruitment intervention methodology will be utilized, involving a researcher interviewing patients at 6 months after the study (with the inclusion of a satisfaction likert question regarding the study) and interviewing the study personnel throughout the trial. Patient identifiers will be kept anonymous throughout the QuinteT process, and the interviewer will be blind to the treatment allocation of the patient. The feasibility assessments will be reported in accordance with the CONSORT 2010 statement: extension to randomized pilot and feasibility trials guidelines.
The team has produced two manuscripts regarding the impact of renal denervation on LPHS patients. The investigators' initial article outlines four successful case studies reported from a single centre, where "half of the four patients experienced complete pain relief post procedure, whereas the other two patients had a 75% improvement in their frequency of analgesic use" . The investigators then conducted a 12-patient cohort study and observed 10/12 patients at 3 months and 11/12 patients at 6 months reporting a >30% reduction in pain based on the McGill pain questionnaire, along with consistent improvements in disability, mood and quality of life.These results provide the investigators with sufficient preliminary results to scale the hypothesis, improve the study design, and introduce more rigor to the methods so the investigators may use an RCT design to more-definitively assess the effectiveness of renal denervation on pain reduction for LPHS patients.
Trial Intervention:
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
The clinical staff (Nephrologist and Nurse) will be blinded to which patients are allocated to the randomized treatment and control groups. Only the interventional radiologist will know at the time of the procedure which group the patient has been assigned to. The radiologist will not be involved with patient follow up following the procedure. This way, the clinical follow-up will not be affected by clinician or patient knowledge of specific patient treatment. Unblinding will occur after the six-month follow-up assessment. The patient will be told the type of treatment received and, if they were allocated to the sham arm, will be offered the opportunity to undergo the RDN procedure. The patient treatment allocation will not be revealed until after the patient's six month follow-up period is complete.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Inclusion criteria for patients to be invited to participate in the study are:
- •≥ 18 years of age
- •Diagnosed with loin pain hematuria syndrome by a nephrologist, in consultation with a urologist.
- •Current use of prescription pain medication for LPHS treatment
- •Arteries with a diameter between 3 mm and 8 mm.
- •Exclusion criteria for patients to be screened out of the study are:
- •History of kidney auto transplantation
- •Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m2
- •Pregnant or nursing
- •Need chronic oxygen support or mechanical ventilation via tracheostomy continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP)
- •Renovascular abnormalities
- •Prior renal angioplasty, indwelling renal stents and/or aortic stent grafts
- •Evidence of a somatoform disorder as per the SCID-5
- •Unavailable to travel to Regina, SK one day prior to the procedure to meet with the Principal Investigator and study coordinator
结局指标
主要结局
Assess the proportion of participants undergo procedures (treatment or sham) within 6 months
时间窗: From the start of the study to 6 months after
We will consider the trial to be feasible if 80% of the target population (10 patients) undergoes procedure (treatment or sham) within 6 months
Assess the of proportion of randomized participants (treatment or control) who entirely complete the follow-up measures
时间窗: From the date of procedure (for each patient) to 6 months after the procedure
We will consider the trial to be feasible if 80% of randomized participants (treatment or control) remain in the trial and entirely complete the follow-up measures.
次要结局
- To assess the change from Baseline pain interference score _Brief Pain Inventory at 6 months after procedure (treatment or control)(From the date of procedure (for each patient) to 6 months after the procedure)
- To assess the change from Baseline morphine-equivalent daily dosage of medication at 6 months after procedure (treatment or control)(From the date of procedure (for each patient) to 6 months after the procedure)
- To assess the change from Baseline pain severity score_Brief Pain Inventory at 6 months after procedure (treatment or control)(From the date of procedure (for each patient) to 6 months after the procedure)
- To assess the change from Baseline CES-D score at 6 months after procedure (treatment or control)(From the date of procedure (for each patient) to 6 months after the procedure)
- To assess the change from Baseline McGill Pain score at 6 months after procedure (treatment or control)(From the date of procedure (for each patient) to 6 months after the procedure)
- To assess the change from Baseline EQ-5D VAS at 6 months after procedure (treatment or control)(From the date of procedure (for each patient) to 6 months after the procedure)
- To assess the change from Baseline SF-36 score at 6 months after procedure (treatment or control)(From the date of procedure (for each patient) to 6 months after the procedure)
- To assess the change from Baseline Oswestry Disability Index at 6 months after procedure (treatment or control)(From the date of procedure (for each patient) to 6 months after the procedure)