NCT05137041已完成3 期
A Phase IIIB Randomized, Open Label, Two Arms and Parallel Group Clinical Trial to Assess the Efficacy and Safety of FIRTECH (Infrared Therapy Patch), for Treating Patients Suffering From Mild to Moderate Acute Low Back Pain
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 221
- 试验地点
- 7
- 主要终点
- Percentage of Numerical Rating Scale (NRS) Responders at Day 5
研究概览
简要总结
Primary Objective:
To assess the efficacy of the infrared therapy patch (ITP) FIRTECH for treating participants suffering from mild to moderate acute low back pain.
Secondary Objectives:
- To assess the efficacy of ITP FIRTECH on participant disability
- To assess the efficacy of ITP FIRTECH on the degree of participant mobility
- To assess the safety of ITP FIRTECH
详细描述
Duration of study participation is up to 6 days per participant.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants suffering from mild to moderate acute low back pain
- •Low back pain (lumbar back pain) is defined as pain in the back from the level of the lowest rib down to the gluteal fold
- •Acute episode is defined as acute pain with less than 1 month duration
- •With intensity less than or equal to 6 on 0-10 Numerical Rating Scale (NRS)
排除标准
- •Participants suffering from any neurological pathology which could be responsible of the pain
- •Participants suffering from leg pain irradiation
- •Participants suffering from chronic lumbar pain of any etiology
- •Participants with chronic arthrosis and neurological symptoms
- •Participants experiencing recent significant trauma (i.e., injury related to a fall from a height or motor vehicle crash, or from a minor fall or heavy lifting in a participants with osteoporosis or possible osteoporosis)
- •Participants with major or progressive motor or sensory deficit, new-onset bowel or bladder incontinence or urinary retention, loss of anal sphincter tone, saddle anesthesia, history of cancer metastatic to bone, and suspected spinal infection
- •Participants clinically diagnosed with anxiety and/or depression
- •Participants using any medication for their pain within the last 48 hours within enrollment into the study
- •Participants taking any systemic medication for their pain within the last 24 hours (48 hours for diclofenac or corticosteroids)
- •Participants currently using recreational or illicit drugs or with a recent history of drug or alcohol abuse or dependence
- •Participants with any other medical condition that would interfere with efficacy and safety assessments based on investigator's judgment
- •Participants having received non-pharmaceutical lower back pain treatment (physiotherapy, heat treatment or massage) within 12 hours prior to enrollment
- •Participants having received spinal injection back pain treatment within 6 months prior to enrollment
- •Participants having received surgery due to back pain or rehabilitation due to back pain in the last 12 months
- •Participants with a known sensitivity to paracetamol
- •Participants with known cutaneous hypersensitivity to plaster
- •Participants participating in another clinical study within the past 30 days
- •Participants who are pregnant or breastfeeding; contraception is mandatory
- •Participants having damaged, non-intact, or scarred skin in or near the point of patch application
- •Participants having a known skin sensitivity
- •Participants having impaired blood circulation
- •The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
研究组 & 干预措施
ITP FIRTECH
Experimental
The ITP FIRTECH patch was applied on the lower back region of the body on Day 1 and intended to be worn for 5 Days (Day 5).
干预措施: ITP FIRTECH (Device)
No Patch Control Arm
No Intervention
No patch application.
结局指标
主要结局
Percentage of Numerical Rating Scale (NRS) Responders at Day 5
时间窗: Day 5
NRS is used to assess pain intensity, it is a 11-point scale (0-10) where '0' representing 'no pain' and '10' representing 'worst pain imaginable'. Responder is defined as participant with ≥30% decrease from baseline in pain NRS and who did not take rescue medication (defined as receiving paracetamol (authorized), any other analgesics and anti-inflammatory drugs as well as any non-pharmaceutical therapy (prohibited) for treating pain starting from randomization to Day 5 or starting before the study and still ongoing at randomization).
次要结局
- Number of Participants Reported With Treatment Emergent Adverse Events (TEAEs)(Day 1 to Day 6)
- Normalized Sum of Pain Intensity Difference (PID) Over 5 Days (SPID0-5)(Baseline, Day 5)
- Percentage Change in Roland-Morris Disability Questionnaire (RMDQ) Score(From Baseline to Day 5)
- Mobility Evaluation Using Schober's Test(Baseline and Day 5)
- Mobility Evaluation Using Fingertip-to-Floor (FTF) Test(Baseline and Day 5)
- Time to Reach Acceptable Pain(Up to Day 5)
- Time to Reach no Pain(Up to Day 5)
- Time Course of PID(Baseline up to Day 5)
- Time Course of Pain Relief(Baseline up to Day 5)
- Normalized Sum of Pain Relief(Baseline up to Day 5)
研究者
研究点 (7)
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