Placebo-Induced Hypoalgesia During Transcutaneous Electrical Nerve Stimulation in Acute Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Feasibility assessed using a structured feasibility questionnaire
研究概览
简要总结
The primary goal of this clinical trial is to evaluate the feasibility of conducting a full-scale randomized controlled trial (RCT), considering recruitment, compliance with study protocols, and adverse events. The secondary goal is to evaluate the effectiveness of a video-based educational explanation of transcutaneous electrical nerve stimulation (TENS) in eliciting placebo-induced hypoalgesia and improving clinical outcomes in patients with acute low back pain.
The main question it aims to answer is: Does the addition of a video-based educational explanation of TENS to standard physical therapy rehabilitation, consisting of TENS and exercises, increase the pressure pain threshold, reduce pain intensity, and improve functional mobility, patient satisfaction, and quality of life in patients with acute low back pain?
Participants will be divided into two groups for comparison: the control group will receive standard physical therapy rehabilitation consisting of TENS and exercises, while the experimental group will receive the same program in addition to the video-based educational explanation of TENS.
详细描述
Pain modulation through expectation is a well-established phenomenon. Anticipating relief from a treatment can enhance the effects of both pharmacological and non-pharmacological analgesic interventions. The expectation of pain relief can reduce the perceived intensity of stimuli and is associated with changes in brain regions involved in pain processing, including the thalamus, prefrontal cortex, and somatosensory cortices. Previous research suggests that expectation can have a moderate to large effect on experimental and acute procedural pain.
Based on this, the investigators hypothesize that adding a video-based educational explanation of TENS to a standard physical therapy rehabilitation program will enhance patient expectations regarding the intervention. This may elicit placebo-induced hypoalgesia and improve clinical outcomes in patients with acute low back pain.
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 (Investigator, Outcomes Assessor)
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
- •acute low back pain without radicular pain to lower limbs
- •minimal pain level of 4 on the 0-10 VAS
- •18-65 years of age
- •TENS naïve or have not used TENS in the past 5 years.
排除标准
- •Radicular pain to lower limbs
- •Serious spinal disorders, such as fractures, tumors, or inflammatory arthritis disease
- •Nerve root disorders confirmed by neurological tests
- •Neurological diseases
- •Severe cardiorespiratory disease
- •Pregnancy
- •Skin infection or lesions or change in sensation at the TENS application site
- •Cardiac pacemaker
- •Allergy to electrodes
- •use of opioids.
研究组 & 干预措施
Experimental: TENS + Educational Video + Exercise Program
Participants in this group will receive transcutaneous electrical nerve stimulation (TENS) along with a structured home exercise program and will also view an educational video explaining TENS.
干预措施: TENS (Device)
Experimental: TENS + Educational Video + Exercise Program
Participants in this group will receive transcutaneous electrical nerve stimulation (TENS) along with a structured home exercise program and will also view an educational video explaining TENS.
干预措施: TENS educational explanation video (Behavioral)
Experimental: TENS + Educational Video + Exercise Program
Participants in this group will receive transcutaneous electrical nerve stimulation (TENS) along with a structured home exercise program and will also view an educational video explaining TENS.
干预措施: Exercise (Other)
Active Comparator: TENS + Exercise Program
Participants in this group will receive transcutaneous electrical nerve stimulation (TENS) along with a structured home exercise program.
干预措施: TENS (Device)
Active Comparator: TENS + Exercise Program
Participants in this group will receive transcutaneous electrical nerve stimulation (TENS) along with a structured home exercise program.
干预措施: Exercise (Other)
结局指标
主要结局
Feasibility assessed using a structured feasibility questionnaire
时间窗: Baseline (Day 1) and 4 weeks post-treatment.
Feasibility will be evaluated using a structured questionnaire designed to assess the practicality of conducting a future randomized controlled trial (RCT), including aspects such as recruitment, adherence, and data collection. Responses will be summarized descriptively.
Success rate of obtaining consent from those eligible participants
时间窗: During the enrolment process
Number of participants enrolled/randomised
Retention rate of the participants
时间窗: Recorded at week 4 at the end of delivering the intervention.
Retention rate is defined as proportion of people that finished the programme after 4 weeks. Retention data will be assessed based on (i) proportion of participants with complete outcome assessment; (ii) number of discontinuation and reasons.
Adherence of the participants
时间窗: Recorded at week 4 at the end of delivering the intervention.
Adherence is defined as the number and proportion of scheduled sessions undertaken by the participants.
次要结局
- Pressure Pain Threshold measured using a pressure algometer(Baseline (Day 1), 4 weeks post-treatment, and 3 months follow-up.)
- Pain intensity measured using the Visual Analogue Scale (VAS)(Baseline (Day 1), 4 weeks post-treatment, and 3 months follow-up.)
- Functional disability measured using the Oswestry Disability Index (ODI)(Baseline (Day 1), 4 weeks post-treatment, and 3 months follow-up.)
- Participant satisfaction measured using the Visual Analogue Scale (VAS)(Baseline (Day 1), 4 weeks post-treatment, and 3 months follow-up.)
- Health-related quality of life measured using the 36-Item Short Form Survey (SF-36)(Baseline (Day 1), 4 weeks post-treatment, and 3 months follow-up.)
研究者
Ahmed ElMelhat
Associate Professor of MSK Physical Therapy, BAU and Cairo university
Cairo University