Clinical Trial Evaluating the Effectiveness and Safety of Dvectis Single and Dvectis Double Pads in Comparison to "no Pad Use" in Patients With Chronic Lumbar Spine Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change of pain intensity of using the Dvectis Single pad in comparison to "use of no pad" in patients at Visit 1 and Visit 2
研究概览
简要总结
1. Introduction
1.1 Description of the Trial
The trial was a monocentric, open, randomized, 3-arm clinical trial that took place at the Department of Orthopaedics of the Karviná Miners' Hospital (Karvinská hornická nemocnice a.s.). The involvement of a maximum total number of 198 patients with chronic lumbar spine pain was planned; the patients were randomly and evenly assigned to one of the 3 treatment groups:
- Use of the Dvectis Single pad;
- Use of the Dvectis Double pad;
- Use of no pad. One sequential interim analysis was planned in the middle of the clinical trial and after this interim analysis, the trial was stopped early due to proven efficacy.
The expected period of participation of each patient in the clinical trial was 6 weeks (± 5 days). For an overview of the individual study visits and procedures, study population and other detailed information, see the study protocol.
According to the plan, the assessment subject was asked during Visit 1 and Visit 2 about the most intensive pain felt in the last 48 hours (PI). The pain was recorded by the subject in the visual analogue scale (VAS) in CRF under supervision of the investigator. Then the assessment subject recorded the intensity of their pain independently in the Patient Journal daily.
1.2 Primary Objective, Quantity and Hypothesis
The primary objective of the clinical trial was to assess the efficacy of using the Dvectis Single pad in comparison to "use of no pad" in patients suffering from chronic lumbar spine pain.
PI was the primary quantity. The primary hypothesis was the superiority of Dvectis Single based on a check, assessed based on the difference in PI (PID) between week 2 and week 6 (PID6).
详细描述
1. Analysed Populations and Number of Subjects
Prior to the statistical analysis, 4 populations were defined in line with the study protocol:
- Population including all randomised subjects (ARS);
- Population of all patient with intention to treat (ITT);
- Population of patients without serious deviation from the clinical trial plan
- Safety population.
Each analysed population was based on a list of its members. Although the treatment group could have generally been different for each patient in a different population (see the study protocol and statistical analysis plan), such a case did not occur (as all the patients were de facto placed in the group to which they were randomized). Therefore the real treatment group is the same as the randomization treatment group for all patients. This fact is not discussed further in the document.
1.1 The ARS population
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
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •inclusion criteria:
- •Age 18-65 years.
- •The Condition of chronic musculoskeletal pain in the lumbar spine (degenerative diseases of the spine) for at least the last 3 months without a major change in the intensity of pain.
- •VAS ≥ 40 mm of lumbar spine pain felt in the last 48 hours.
排除标准
- •Chronic pain caused by diseases other than degenerative diseases of the spine.
- •Any condition/disease or medicine found in the medical history of the screening, which in the investigator's opinion could affect the assessment of the intensity of pain.
- •Physiotherapeutic rehabilitation in the spine planned at the time of participation in the clinical test.
- •Pregnant or breastfeeding woman.
- •Simultaneous participation in another clinical investigation or study.
- •Inability to understand patient Information and unwillingness to cooperate in compliance with the clinical investigation instructions.
- •Unsigned Informed consent.
- •Criteria for early termination of participation:
- •The subject's wish to end participation.
- •The Occurrence of non-inclusion criteria during the clinical investigation.
- •Occurrence of a serious adverse event or other circumstance where further persistence in the clinical investigation would endanger the subject's health.
- •Impossibility to comply with the clinical investigation plan, e.g. Insufficient compliance with the guidelines by the subject or for organisational reasons.
- •Deterioration of the subject's health status, which will require unauthorised treatment.
研究组 & 干预措施
Use of the Dvectis Single pad
The Dvectis Single Dynamic-directional pad is a basic model of the Dvectis product range that provides full functionality based on the dynamic-directional seating principle. The Dvectis Single pad is designed to steer muscle tension during sitting in deep-seated muscles. The Dvectis Single pad is intended to eliminate chronic lumbar spine pain by strengthening the stabilizing muscles.
干预措施: Use of the Dvectis Single pad (Other)
Use of the Dvectis Single pad
The Dvectis Single Dynamic-directional pad is a basic model of the Dvectis product range that provides full functionality based on the dynamic-directional seating principle. The Dvectis Single pad is designed to steer muscle tension during sitting in deep-seated muscles. The Dvectis Single pad is intended to eliminate chronic lumbar spine pain by strengthening the stabilizing muscles.
干预措施: Use of no pad (Other)
Use of the Dvectis Double pad
The Dvectis Double Dynamic-directional pad is based on the Dvectis Single model, but in addition to its dual-chamber design, it provides seating with a more balanced load and a higher dynamic-directional effect. The Dvectis Double pad is designed to create and route muscle tension during sitting in deep-seated muscles. The Dvectis Double is also suitable for soft substrates (sofa, soft chair, etc.). The Dvectis Double Pad is intended to remove chronic lumbar spine pain by strengthening the stabilizing muscles.
干预措施: Use of the Dvectis Double pad (Other)
Use of the Dvectis Double pad
The Dvectis Double Dynamic-directional pad is based on the Dvectis Single model, but in addition to its dual-chamber design, it provides seating with a more balanced load and a higher dynamic-directional effect. The Dvectis Double pad is designed to create and route muscle tension during sitting in deep-seated muscles. The Dvectis Double is also suitable for soft substrates (sofa, soft chair, etc.). The Dvectis Double Pad is intended to remove chronic lumbar spine pain by strengthening the stabilizing muscles.
干预措施: Use of no pad (Other)
Use of no pad
Description is not needed
结局指标
主要结局
Change of pain intensity of using the Dvectis Single pad in comparison to "use of no pad" in patients at Visit 1 and Visit 2
时间窗: 6 weeks between visits
Pain intensity was measured on a 100 mm Visual Analogue Scale (VAS). VAS is a graphic record where the patient indicates the intensity of pain on a 100 mm long line, where 0 mm means no pain and 100 mm means unbearable pain. The degree of pain intensity is the distance from the left end of the line to the patient indicated by the value in millimeters. The participating subject was asked for experiencing the greatest pain in the last 48 hours during the Visit 1 and Visit 2. The pain was recorded by the subject under supervision of the investigator at Visit 1 and Visit 2. Change of VAS values in mm (0-100mm) between Visit 1 and 2 was evaluated for all subjects. Finaly the overall changes of pain intensity of patients using the Dvectis Single pad in comparison to "use of no pad" were evaluated by statistician.
次要结局
- Change of pain intensity of using the Dvectis Double pad in comparison to "use of no pad" in patients at Visit 1 and Visit 2(6 weeks between visits)