Effectiveness of a Sensory Stimulation Belt for Office Workers With Chronic Nonspecific Low Back Pain: A Double-Blind, Sham-Controlled Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change in low back pain intensity
研究概览
简要总结
This randomized, double-blind, sham-controlled trial will evaluate the effectiveness of a sensory stimulation belt in office workers with chronic nonspecific low back pain. Participants will first complete baseline clinical and sensorimotor assessments and will then be randomly assigned in a 1:1 ratio to receive either an active sensory stimulation belt or a sham belt.
Participants will wear the assigned belt during their usual office work for at least 4 hours per day, 5 days per week, for 4 weeks. Daily belt use, pain intensity, adherence, skin reactions, and device-related problems will be recorded in a study logbook, with weekly follow-up by the research team.
Clinical outcomes will include pain intensity, frequency and intensity of low back pain or discomfort episodes, low back pain-related disability, work-related musculoskeletal discomfort, tactile acuity, and pressure pain threshold. Mechanistic outcomes will include corticospinal excitability, somatosensory cortical responses during unstable sitting, postural control, lumbar multifidus motor-unit behavior, and lumbar multifidus contractile response.
The primary objective is to determine whether 4 weeks of active lumbar sensory stimulation produces greater improvements in clinical outcomes than a sham intervention and whether clinical changes are accompanied by changes in sensorimotor and neuromuscular outcomes.
详细描述
Phase III is a prospective, double-blind, sham-controlled randomized clinical trial designed to evaluate the clinical effectiveness and potential sensorimotor mechanisms of a wearable sensory stimulation belt in office workers with chronic nonspecific low back pain.
After eligibility screening and written informed consent, participants will undergo a baseline laboratory assessment. Baseline clinical assessments will include pain intensity, low back pain-related disability, work-related musculoskeletal discomfort, movement-control testing, tactile acuity, and pressure pain threshold.
Baseline mechanistic assessments will characterize corticospinal, cortical, postural, motor-unit, and lumbar multifidus function. Corticospinal excitability will be assessed using single-pulse transcranial magnetic stimulation (TMS), with motor-evoked potentials recorded from the lumbar multifidus and erector spinae muscles. Somatosensory cortical and postural responses will be assessed during unstable sitting using functional near-infrared spectroscopy (fNIRS) over the bilateral primary somatosensory cortex together with inertial measurement units (IMUs). Participants will also perform a repeated loaded forward-bending task while lumbar multifidus motor-unit behavior is recorded using decomposition electromyography (dEMG) and trunk movement is recorded using IMUs. Lumbar multifidus morphology and contractile response will be assessed using rehabilitative ultrasound imaging (RUSI) at rest and during contralateral arm lifting.
Following completion of the baseline assessment, participants will be randomly allocated in a 1:1 ratio to an active sensory stimulation belt group or a sham belt group using a computer-generated block randomization sequence. Allocation will be concealed using sequentially numbered, opaque, sealed envelopes prepared by a research assistant who is not involved in outcome assessment.
Participants assigned to the active intervention group will receive a sensory stimulation belt programmed with the lumbar vibration parameters identified during the preceding Phase II parameter-optimization study. Participants assigned to the sham group will receive a belt designed to have similar appearance, weight, sound, and user interface. The sham belt will provide only a brief, low-level surface vibration at the beginning of use and will subsequently cease active stimulation so that it does not provide the intended sustained sensory stimulation.
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, Outcomes Assessor)
盲法说明
Participants and outcome assessors will be blinded to group allocation. The active and sham belts will be designed to have similar appearance, weight, sound, and user interface. Device allocation and programming will be performed by research personnel who are not involved in outcome assessment. The sham belt will provide a brief, low-level surface vibration at the beginning of use but will not provide the sustained stimulation delivered by the active belt.
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Office workers who currently sit for at least 6 hours per workday.
- •Age between 20 and 60 years.
- •Chronic nonspecific low back pain for at least 3 months.
- •Current pain intensity of at least 2/10 on the Numeric Pain Rating Scale.
排除标准
- •History of seizure in the participant or a family member.
- •Implanted pacemaker.
- •Contraindications to TMS or fNIRS, including relevant open wound, infection, skin lesion, or other condition preventing safe measurement.
- •Acute cerebral hemorrhage.
- •History of major spinal surgery, fracture, or traumatic injury to the lumbar spine.
- •Evidence of neurological deficits, including radiculopathy, loss of sensation, or motor weakness in the lower limbs.
- •Diagnosis of a systemic inflammatory condition, including ankylosing spondylitis or rheumatoid arthritis.
- •Allergy to adhesives or history of severe skin sensitivity to vibration or mechanical pressure.
- •Body mass index greater than 30 kg/m2 because of potential effects on RUSI, dEMG, and fNIRS signal quality.
研究组 & 干预措施
Active Sensory Stimulation Belt
Participants will receive an active sensory stimulation belt programmed using the optimized lumbar vibration parameters identified during Phase II. Participants will wear the belt during usual office work for at least 4 hours per day, 5 days per week, for 4 weeks.
干预措施: Active Sensory Stimulation Belt (Device)
Sham Sensory Stimulation Belt
Participants will receive a sham belt designed to resemble the active belt in appearance, weight, sound, and user interface. The sham device will provide a brief, low-level surface vibration at the beginning of use and will subsequently cease active stimulation. Participants will wear the sham belt during usual office work for at least 4 hours per day, 5 days per week, for 4 weeks.
干预措施: Sham Sensory Stimulation Belt (Device)
结局指标
主要结局
Change in low back pain intensity
时间窗: Baseline and 4 weeks
Pain intensity will be measured using the 11-point Numeric Pain Rating Scale (NPRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Current pain and average pain during the previous 7 days will be recorded. Change in pain intensity from baseline to the end of the 4-week intervention will be compared between the active and sham groups.
Frequency of low back pain or discomfort episodes
时间窗: Daily during the 4-week intervention
Participants will record the occurrence of low back pain or discomfort episodes in a daily study logbook throughout the 4-week intervention. The number of episodes will be summarized over the intervention period and compared between the active and sham groups.
Daily change in low back pain intensity associated with belt use
时间窗: Before and after belt use on each study day for 4 weeks
Participants will rate low back pain intensity using the 0-10 Numeric Pain Rating Scale immediately before the first belt-wear period and after the final belt-wear period of each study day. Repeated daily pain responses will be compared between the active and sham groups.
Change in low back pain-related disability
时间窗: Baseline and 4 weeks
Low back pain-related disability will be assessed using the Oswestry Disability Index (ODI). The questionnaire score is expressed as a percentage, with higher scores indicating greater disability. Change from baseline to 4 weeks will be compared between groups.
Change in work-related musculoskeletal discomfort
时间窗: Baseline and 4 weeks
Work-related musculoskeletal discomfort will be assessed using the Cornell Musculoskeletal Discomfort Questionnaire (CMDQ), which evaluates the frequency, severity, and interference with work associated with musculoskeletal discomfort during the previous working week. The lower-back score and total CMDQ score will be analyzed.
Change in lumbar tactile acuity
时间窗: Baseline and 4 weeks
Lumbar tactile acuity will be assessed using a three-point aesthesiometer to determine two-point discrimination threshold over the lumbar region. Lower discrimination thresholds indicate greater tactile spatial acuity.
Change in pressure pain threshold
时间窗: Baseline and 4 weeks
Pressure pain threshold will be measured using a digital pressure algometer at predefined local lumbar and remote anatomical sites. Pressure will be gradually increased until the participant first reports pain. Change in pressure pain threshold from baseline to 4 weeks will be compared between groups.
次要结局
- Change in lumbar multifidus and erector spinae motor-evoked potential amplitude(Baseline and 4 weeks)
- Change in active motor threshold of lumbar multifidus and erector spinae measured by transcranial magnetic stimulation(Baseline and 4 weeks)
- Change in motor-evoked potential latency of lumbar multifidus and erector spinae(Baseline and 4 weeks)
- Change in cortical motor map volume of lumbar multifidus and erector spinae(Baseline and 4 weeks)
- Change in cortical motor map area of lumbar multifidus and erector spinae(Baseline and 4 weeks)
- Change in oxygenated hemoglobin concentration in the bilateral primary somatosensory cortex during unstable sitting(Baseline and 4 weeks)
- Change in deoxygenated hemoglobin concentration in the bilateral primary somatosensory cortex during unstable sitting(Baseline and 4 weeks)
- Change in total hemoglobin concentration in the bilateral primary somatosensory cortex during unstable sitting(Baseline and 4 weeks)
- Change in lumbar resultant angular velocity during unstable sitting(Baseline and 4 weeks)
- Change in number of lumbar multifidus motor units during loaded forward bending(Baseline and 4 weeks)
- Change in lumbar multifidus motor-unit action-potential amplitude during loaded forward bending(Baseline and 4 weeks)
- Change in lumbar multifidus motor-unit firing rate during loaded forward bending(Baseline and 4 weeks)
- Change in lumbar multifidus percentage thickness change during contraction(Baseline and 4 weeks)
- Change in lumbar multifidus absolute thickness change during contraction(Baseline and 4 weeks)
- Belt-wear adherence(Daily throughout the 4-week intervention)
- Number of participants with device-related adverse events(Throughout the 4-week intervention)
研究者
Peemongkon Wattananon
Associate Professor
Mahidol University