NCT06700109进行中（未招募）不适用
INJECTABLE COLD ENERGY THERAPY FOR THE MANAGEMENT OF CHRONIC PAIN ASSOCIATED WITH OSTEOARTHRITIS OF THE KNEE: A MULTI-CENTER, RANDOMIZED, CONTROLLED STUDY (ICE STUDY)
Brixton Biosciences, Inc.15 个研究点 分布在 1 个国家目标入组 263 人开始时间: 2024年11月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 263
- 试验地点
- 15
- 主要终点
- Primary Effectiveness
研究概览
简要总结
The goal of this clinical trial is to evaluate the effectiveness of Neural Ice for pain management associated with knee osteoarthritis in adults aged 22-80 years. Participants will attend study visits and complete subject diaries. Participants will be followed for 6 months after study procedure.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 22 to 80, inclusive of any gender
- •Baseline pain intensity of >/= 5 of the Numeric Rating Scale (NRS) despite current treatment Confidential Brixton Biosciences Inc. Page 12 of 53 Version: 1.1, 30 August 2024
- •Chronic symptomatic osteoarthritis of the knee (K-L stage 2, 3, or 4) on plain x-rays obtained within the previous 12 months
- •At least 3 months of previous conservative treatments (NSAID, acetaminophen, physical therapy, cortisone injections) that are not currently providing relief
- •Agree to see one doctor (study investigator) for knee pain during the study period
- •Willing/able to understand the informed consent form and provide written informed consent
- •Able to complete outcome measures (including electronic patient reported outcome measures)
排除标准
- •Known allergy to glycerol, hyaluronic acid, poloxamer 407, or phosphate buffered saline
- •History of cryoglobulinemia
- •History of cold-induced auto-immune hemolytic anemia (e.g. paroxysmal cold hemoglobinuria or cold agglutinin disease)
- •History of cold urticaria
- •History of Chilblain's (pernio) disease in the lower extremities
- •History of Raynaud's disease
- •Open and/or infected wounds or active tumor at or near the treatment site
- •History of vascular surgery involving femoral vessels on the injection side
- •History of surgical procedures to affected limb that, in the opinion of the investigator, could have impacted the integrity of the genicular nerves or blood vessels
- •Active bacterial or fungal infection that at the discretion of the investigator would preclude study participation
- •Currently taking >60 MME/day, as determined per MDcalc.com (opioid conversion calculator)
- •History of History of systemic inflammatory conditions such as rheumatoid arthritis
- •Bleeding disorders anticoagulant therapy, unless appropriately stopped or reversed for the procedure
- •Any condition or circumstance that would impact or confound assessment of safety and/or pain. For example, comorbid or concomitant pain conditions, pre-existing lower limb neurologic deficits, any psychiatric or neurologic disease
- •Cryoneurolysis, thermal or pulsed radiofrequency ablation, or phenol injection for the index knee within the past 12 months
- •Use of intra-articular injection of corticosteroid within the previous 3 months, or hyaluronic acid, prolotherapy, Confidential Brixton Biosciences Inc. Page 13 of 53 Version: 1.1, 30 August 2024 autologous blood, or platelet rich plasma injections for the index knee within the previous 6 months
- •Known contraindication to use of a regional anesthetic block
- •Pregnant, nursing or intent of becoming pregnant during the study period
- •Any condition (such as history of significant cardiovascular, renal failure/dialysis, hepatic or other systemic comorbidity/chronic pain condition) or circumstance that, in the opinion of the investigator, would compromise the safety of the subject or the quality of study data
- •Body habitus/knee anatomy that would preclude the use of the product injection needle size
- •Participation in any clinical study of a therapeutic investigational product within 30 days prior to enrollment
- •Unwilling to refrain from participation in any other clinical study through the duration of this study
- •Unwilling to refrain from any scheduled surgeries during the duration of this study
研究组 & 干预措施
Neural Ice injections
Experimental
This therapy will be injected around the superolateral, superomedial, and inferomedial genicular nerves.
干预措施: Neural Ice (Device)
Corticosteroid injection
Active Comparator
Intraarticular corticosteroid injection is defined as a single dose of Triamcinolone 40mg injected directly into the joint space.
干预措施: Triamcinolone acetate (Drug)
结局指标
主要结局
Primary Effectiveness
时间窗: 3 months
The proportion of subjects whose knee pain following activity (Timed Up and Go test) is reduced by ≥30% based on the NRS scale at 3 months post treatment.
Primary Safety
时间窗: 6 months
Aggregate serious device-related adverse events through final follow up visit.
次要结局
- Secondary Effectiveness(6 months)
- NRS Scores(6 months)
- Pain medication usage(6 months)
- PGIC scores(6 months)
- KOOS, JR scores(6 months)
- Onset of pain relief defined as pain reduced by 30% based on NRS score from baseline(6 months)
- Change in Timed-Up and Go (TUG) test scores from baseline(6 months)
研究者
研究点 (15)
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