Acute Effects of Thoracolumbar Fascia Myofascial Release Technique on Cortical Activity: A Sham-Controlled Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Change in Sensorimotor Mu Rhythm Power (C3, C4 channels)
研究概览
简要总结
This study will examine the immediate (acute) effects of a single myofascial release technique applied to the thoracolumbar fascia on brain activity in healthy young adults aged 18-25. Using a sham-controlled, randomized design, participants will be assigned to either an active treatment group, receiving a 10-minute myofascial release technique to the lower back, or a sham control group, receiving light surface touch to the same area for the same duration without any therapeutic pressure or movement.
Brain activity will be recorded using a portable, 8-channel wireless EEG system before the intervention, shortly after it (0-10 minutes), and again 30 minutes later, allowing researchers to track how cortical activity changes over time. Measurements will focus on sensorimotor rhythms (mu rhythm) and posterior alpha power, along with heart rate variability, to assess whether the myofascial technique produces effects that go beyond those of simple touch. The main goal is to determine whether this hands-on technique produces a measurable, distinct pattern of brain activity compared to a sham (placebo-like) touch condition.
详细描述
The thoracolumbar fascia (TLF) is increasingly recognized not merely as a passive connective tissue structure, but as a neurophysiologically relevant tissue involved in mechanical loading, proprioception, nociception, and sensorimotor integration. Biomechanical studies have shown that the lumbodorsal/thoracolumbar fascia exhibits viscoelastic properties responsive to mechanical stress, and narrative reviews have proposed this tissue as a potential source of low back pain. Schleip's neurobiological model further suggests that myofascial techniques may act not only through mechanical tissue deformation, but through stimulation of mechanoreceptors within the fascia, potentially producing measurable changes at the level of the central nervous system rather than being limited to local peripheral effects.
While clinical outcomes of myofascial release (e.g., pain, range of motion, postural parameters) have been studied more extensively, the acute cortical electrophysiological effects of a thoracolumbar-fascia-targeted myofascial technique - distinguished from a sham/superficial touch condition - remain insufficiently investigated. Electroencephalography (EEG) offers a non-invasive method with high temporal resolution to examine changes in alpha, mu, beta, and theta band activity associated with tactile stimulation, somatosensory processing, pain modulation, and sensorimotor integration following manual intervention.
This study is designed as a two-arm, parallel-group, sham-controlled, single-blind (data analyst blinded) randomized controlled trial. Acute effects will be assessed within a single session, with data collected at three time points: baseline (pre), early post-intervention (0-10 minutes), and late post-intervention (30 minutes).
Participants will be randomized 1:1 to an active treatment group or a sham control group using block randomization (block size 4), stratified by sex and physical activity level (IPAQ-short: low/moderate/high). The randomization list will be generated by an independent statistician using the 'blockrand' package in R. Allocation concealment will be achieved through sequentially numbered, opaque, sealed envelopes (SNOSE), opened in the participant's presence after baseline measurements are completed. Participants will be partially blinded, as the sham condition will be presented as a placebo intervention; the treating therapist will not be blinded; the EEG operator will be blinded where possible; and the data analyst will be blinded throughout.
Due to the conflict between the prone positioning required for the myofascial technique and the higher EEG signal quality obtained in the supine position, a "sandwich protocol" will be used: baseline EEG will be recorded in the supine position, the participant will then be repositioned prone for the intervention, and subsequently returned to supine for early and late post-intervention EEG recordings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will be partially blinded, as the sham (light touch) condition will be presented to them as a placebo intervention, without disclosing which condition is active or inactive. The therapist delivering the intervention will not be blinded, as the nature of the technique (sustained moderate pressure vs. light superficial touch) cannot be concealed from the person applying it. The EEG operator will be blinded to group allocation where feasible. The data analyst responsible for EEG signal processing and statistical analysis will be blinded to group assignment throughout, with group codes masked during analysis to minimize assessment and analytic bias.
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-25 years
- •Self-reported healthy status
- •Literate in Turkish
排除标准
- •Active epilepsy or seizure history
- •Diagnosed psychiatric disorder
- •Neurological disorder
- •Cardiac arrhythmia, pacemaker, or heart disease
- •Active use of psychotropic, beta-blocker, anticholinergic, or antihistaminic medication
- •Recreational substance use within the past month
- •Pregnancy
- •Active scalp lesion or dermatological pathology
- •Active chronic low back pain
- •History of lumbar disc herniation
- •History of lumbar/thoracic spine surgery
- •Active skin lesion on the back
研究组 & 干预措施
Active Comparator: Thoracolumbar Fascia Myofascial Release
Participants in this arm will receive a single 10-minute myofascial release technique (Pilat myofascial induction crossed-hands technique, or an equivalent thoracolumbar-fascia-specific method) applied to the T10-L4 thoracolumbar fascia region while in the prone position, delivered by a certified myofascial therapist using sustained moderate pressure (1.5-2.5 kg). EEG and ECG recordings will be obtained before the intervention (supine), and again at 0-10 minutes and 30 minutes after the intervention (supine), following a "sandwich protocol."
干预措施: Thoracolumbar Fascia Myofascial Release (Pilat MIF Crossed-Hands Technique) (Other)
Arm 2 - Sham Comparator: Light Surface Touch (Control)
Participants in this arm will receive light surface contact (less than 0.5 kg pressure) over the same thoracolumbar region and for the same 10-minute duration as the active treatment group, without any sliding motion or pressure variation. The condition will be presented to participants as a placebo intervention to maintain partial blinding. EEG and ECG recordings will follow the same "sandwich protocol" and timing as the active group.
干预措施: Sham (Light Surface Touch) (Other)
结局指标
主要结局
Change in Sensorimotor Mu Rhythm Power (C3, C4 channels)
时间窗: Baseline (pre-intervention), early post-intervention (0-10 min), and late post-intervention (30 min)
Power spectral density in the mu rhythm frequency band (assessed via alpha/beta range activity over sensorimotor cortex) will be calculated from EEG channels C3 and C4 using Welch's method, and compared between baseline and post-intervention time points and between the active and sham groups.
Change in Posterior Alpha Power (Pz channel)
时间窗: Baseline (pre-intervention), early post-intervention (0-10 min), and late post-intervention (30 min)
Power spectral density in the alpha frequency band will be calculated from EEG channel Pz using Welch's method, and compared between baseline and post-intervention time points and between the active and sham groups.
次要结局
- Change in Heart Rate Variability - RMSSD(Baseline, early post-intervention (0-10 min), late post-intervention (30 min))
- Change in Heart Rate Variability - LF/HF Ratio(Baseline, early post-intervention (0-10 min), late post-intervention (30 min))
- Change in Frontal Alpha Asymmetry(Baseline, early post-intervention (0-10 min), late post-intervention (30 min))
- Change in Heartbeat-Evoked Potential (HEP) Amplitude (Cz channel)(Baseline, early post-intervention (0-10 min), late post-intervention (30 min))
- Change in Visual Analog Scale (VAS) Score for Local Touch Sensation(Immediately after the intervention; 24-hour follow-up)
- Change in Visual Analog Scale (VAS) Score for Back Pain(Immediately after the intervention; 24-hour follow-up)
研究者
Ertugrul Deniz Kose
Assist. Prof. Dr.
Amasya University