Evaluation of the Benefit and Safety of Localized Tissue Hydration (HTL) in the Management of Chronic Common Low Back Pain: Phase II Monocentric Non-randomized Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Success rate
研究概览
简要总结
The purpose of this study is to evaluate the benefit of Localized Tissue Hydration associated with standard management of chronic common low back pain, in terms of improvement in the numerical verbal scale score at 6 months.
详细描述
This is a proof-of-concept, single-center, prospective, interventional, non-randomized Phase II study designed to evaluate the benefit of 0.9% sodium chloride Localized Tissue Hydration in patients with chronic common low back pain.
The study corresponds to a clinical trial of a medicinal product in compliance with Regulation (EU) n°536/2014.
The study population is composed of patients suffering from chronic common low back pain for more than 3 months with a numerical verbal scale ≥ 5.
Patients will receive a localized subcutaneous injection of 0.9% sodium chloride over 10 sessions (1 session per week), combined with standard management including stage I and II analgesics and physiotherapy in accordance with the recommendations of the French National Authority for Health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patient 18 years of age or older ;
- •Patient with chronic, non-operated low-back pain operated for more than 3 months (verbal numerical scale ≥ 5);
- •Chronic common lumbago not requiring surgical management surgical ;
- •Lumbar MRI performed as part of routine care and available available for the inclusion visit;
- •For women of childbearing age, use of a highly effective contraceptive method;
- •Patient affiliated to a French health insurance scheme;
- •Patient has signed an informed consent form.
排除标准
- •Pregnant or breast-feeding woman;
- •Patient in accident at work ;
- •Patient with radicular syndrome;
- •Contraindication to magnetic resonance imaging or CT scan;
- •Severe cases of hydric inflation and hydrosodic retention, particularly in cases of :
- •Decompensated heart failure;
- •Acute renal failure with oliguria or anuria;
- •Decompensated liver failure;
- •Pre-eclampsia/eclampsia.
- •Hypochloremia ;
- •Hypernatremia ;
- •Patients of legal age subject to legal protection, guardianship, curatorship or deprived of liberty by judicial or administrative decision;
- •Patient hospitalized without consent;
- •Patient unable to answer a questionnaire;
- •Patients who do not understand or speak French.
- •Exclusion period for inclusion in another study :
- •Included patients will not be allowed to participate in another interventional study during the entire follow-up period. The exclusion period is 8.5 months.
研究组 & 干预措施
Localized Tissue Hydration with standard care
Localized tissue injections of saline in the routine management of pain and functional disability in patients with chronic common low back pain.
干预措施: Sodium Chloride injection (Drug)
结局指标
主要结局
Success rate
时间窗: 6 months
Success rate after treatment with Localized Tissue Moisturization combined with standard management, defined by a reduction in the Verbal Numerical Scale score of at least 30%.
次要结局
未报告次要终点