Immediate Effects of Transcutaneous Electrical Nerve Stimulation on the Lumbar Erector Spinae Muscles' Stiffness and Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in lumbar erector spinae muscle stiffness
研究概览
简要总结
Low back pain is frequently associated with increased tone and stiffness of the lumbar erector spinae muscles, which may contribute to pain and functional limitation. Transcutaneous electrical nerve stimulation (TENS) is a non-invasive, safe, and widely used modality for pain reduction, but its very short-term (immediate) effects on lumbar muscle stiffness have not been clearly demonstrated. This randomized controlled trial will compare a single 20-minute session of conventional TENS with a control/rest condition in patients with non-specific low back pain. The primary outcomes will be change in lumbar erector spinae muscle stiffness (Myoton) and change in pain intensity (VAS) from baseline to immediately after the intervention. We hypothesize that TENS will produce a greater immediate reduction in muscle stiffness and pain than control.
详细描述
Low back pain (LBP) is one of the most common musculoskeletal problems and often presents with increased paraspinal muscle activity and perceived stiffness around the lumbar region. Increased stiffness of the lumbar erector spinae may perpetuate pain and restrict movement. TENS provides afferent stimulation that can modulate pain through gate-control and descending inhibitory mechanisms and may secondarily reduce muscle tone. However, evidence about its acute influence on objective muscle stiffness parameters in LBP is limited.
This single-center, parallel-group, randomized controlled trial will recruit adults with chronic or recurrent non-specific low back pain who meet the eligibility criteria. Participants will be randomly assigned (1:1) to (1) an experimental group receiving conventional TENS applied bilaterally over the lumbar paraspinal area for 20 minutes (frequency ~80-100 Hz, pulse width ~100-150 μs), or (2) a control group undergoing the same positioning and timing without active TENS. All assessments will be performed immediately before and immediately after the intervention by an outcome assessor blinded to group allocation.
Primary outcomes are: (a) lumbar erector spinae muscle stiffness measured with a handheld myotonometer (e.g. Myoton) at standardized lumbar levels, and (b) pain intensity measured with a 10-cm visual analog scale (VAS). Secondary observations may include participant-reported comfort/tolerance of TENS and adverse events. The study is designed as a short-term physiological and symptomatic trial; no long-term follow-up is planned. Ethical approval was obtained from the Erzurum Technical University Ethics Committee (Meeting 13, Decision 04, 18.09.2025)
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
- Single (Outcomes Assessor)
盲法说明
The assessor who performs Myoton and VAS measurements will be blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18-30 years
- •Non-specific low back pain persisting or recurring for ≥3 months
- •Reported tenderness/stiffness on palpation of the lumbar erector spinae muscles
- •Able to understand the study procedures and provide written informed consent
- •Able to attend on the same day for TENS application and pre-/post-intervention measurements
排除标准
- •Low back pain with a specific cause (e.g. lumbar disc herniation with radiculopathy, infection, tumor, fracture, severe deformity)
- •Open wound, dermatitis, or any skin condition in the lumbar area that prevents electrode placement
- •Presence of a cardiac pacemaker or other implanted electronic device
- •Electrotherapy, injection, or manual therapy applied to the lumbar region within the previous 48 hours
- •Severe neurological deficit or sensory loss
- •Use of analgesics/NSAIDs at a level that may interfere with pain or stiffness assessment at the time of evaluation
- •Any other condition deemed unsafe or inappropriate by the investigator
结局指标
主要结局
Change in lumbar erector spinae muscle stiffness
时间窗: Baseline (pre-intervention) and immediately post-intervention (within ~5 minutes of completing the 20-minute session)
Muscle stiffness of the lumbar erector spinae will be measured with a handheld myotonometer (e.g. Myoton) at standardized lumbar levels. The outcome is the change score (post - pre) between TENS and control groups. Lower values indicate reduced stiffness.
Change in pain intensity (VAS)
时间窗: Baseline (pre-intervention) and immediately post-intervention (within ~5 minutes of completing the 20-minute session)
Pain intensity will be assessed using a 10-cm Visual Analog Scale (0 = no pain, 10 = worst pain). The outcome is the change score (post - pre) to compare TENS and control groups. Lower scores indicate pain reduction.
次要结局
未报告次要终点
研究者
esedullah akaras
Dr.
Erzurum Technical University