Pain Relief in Patients With Chronic Low Back Pain Using HeatTens vs. Standard Care.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Movement Evoked Pain
研究概览
简要总结
A two-armed randomized controlled clinical trial with blind assessments and a follow-up period of 4 weeks is developed. The aim of this study is to investigate the effects of the combination of heat and TENS (HeatTENS device) on pain in people with chronic low back pain. A sample of 70 patients will be recruited. Following baseline measurements, subjects will be randomly allocated to the experimental or the control group. The experimental group will be asked to use the device on a daily basis, 30 minutes per day. The control group will have no device. After 4 weeks of FU, measurements will be repeated.
详细描述
Drop out:
If subjects drop out, due to any kind of reason, a new participant will be included in order to obtain the predetermined number of participants. Data collected from the participant that dropped out will be deleted and not taken into account in the further analysis.
Analysis of the samples:
Sample size is based on data from (Dailey et al. 2013). Researchers found a significant difference in the reduction of movement-evoked pain (pain during the 6 minutes' walk test (6MWT)) ((4.0 ± 2.5) on a 0-10 VAS) when compared to no TENS (5.0 ± 2.6) (p<0.05) in patients with primary fibromyalgia.
In this study the response within each subject group was normally distributed. If the true difference in the experimental and control means is 1.0, effect size is calculated to be 0,2 (by means of G*Power version 3.1.9.3). 29 experimental subjects and 29 control subjects need to be included to be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.8. The Type I error probability associated with this test of this null hypothesis is 0.05. To take into account a 15% loss of data sample size is inflated up to 33 per group (n/0.85). Sample size is augmented by 10% per potential confounding factor (i.e. age and sex). The total sample size to be recruited will be 70 subjects.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic nonspecific LBP for at least 3 months' duration: non-specific LBP implies that patients are not allowed to have any evidence of specific spinal pathology (e.g., hernia, spinal stenosis, spondylolisthesis, infection, spinal fracture or malignancy).
排除标准
- •spinal surgery in the past 6 months
- •severe underlying comorbidity (like diagnosed diabetes, cardiovascular problems, etc.),
- •pregnant or given birth in the preceding year,
- •having initiated a new LBP treatment in the 6 weeks prior to study participation
研究组 & 干预措施
HeatTens
After baseline measurements and during 4 weeks of follow up
Composition and dosing of the device:
HeatTens (HV-F311-E) 2 - 108 Hz (modulation), 100 microsec (pulse duration) for 30 minutes.
干预措施: HeatTens (HV-F311-E) (Device)
Control group
No intervention
结局指标
主要结局
Movement Evoked Pain
时间窗: Change from Baseline Movement Evoked Pain after treatment and at 4 weeks
Pain that is experienced in response to a physical task. Participants will perform 5 physical tasks (= 1) grasping toes with fingertips in a sitting position; 2) forward bending from standing; 3) picking up paper from standing; 4) long-sitting from supine and 5) lifting a 5kg box from floor to table). Participants will provide a pain rating on a 11 points Numeric Rating Scale (NRS) with the endpoints no pain" (0) and "excruciating pain" (10)
次要结局
- 5 minute walk test (5MWT)(Change from Baseline 5MWT after treatment and at 4 weeks)
- Temporal summation (TS)(Change from Baseline Tempral Summation after treatment and at 4 weeks)
- Conditioned pain modulation(Change from Baseline Conditioned pain modulation after treatment and at 4 weeks)
- Pressure Pain Threshold (PPT)(Change from Baseline Pressure Pain Threshold after treatment and at 4 weeks)
- Body composition and Body Mass Index (BMI)(Change from Baseline Body composition and BMI at 4 weeks follow up)
- Fear Avoidance Beliefs Questionnaire- work(Change from Baseline Fear Avoidance Beliefs Questionnaire after treatment and at 4 weeks)
- Quality of life (SF-36)(Change from Baseline Quality of Life after treatment and at 4 weeks)
- Central sensitization inventory(Change from Baseline Central sensitization inventory after treatment and at 4 weeks)
研究者
Lynn Leemans
Principal Investigator
Vrije Universiteit Brussel