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Acute Effects of Thoracolumbar Fascia Myofascial Release on Cortical Activity

Acute Effects of Thoracolumbar Fascia Myofascial Release Technique on Cortical Activity: A Sham-Controlled Randomized Study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07728617
Acronym
MFR-EEG
Enrollment
124
Registered
2026-07-27
Start date
2026-09-01
Completion date
2028-08-31
Last updated
2026-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healty Volunteers

Keywords

Thoracolumbar fascia, Myofascial release, Electroencephalography, Sensorimotor Mu Rhythm, Cortical Activity, Sham-Controlled Trial, Heart Rate Variability

Brief summary

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.

Detailed description

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. The active treatment group will receive a 10-minute myofascial release technique (Pilat myofascial induction crossed-hands technique or an equivalent TLF-specific method) targeting the T10-L4 thoracolumbar fascia region, applying sustained moderate pressure (1.5-2.5 kg). The sham control group will receive light surface contact (\<0.5 kg) over the same region and duration, without any sliding or pressure variation, presented to participants as a placebo intervention. EEG will be recorded using an 8-channel wireless system (Enobio 8, Neuroelectrics), 24-bit resolution, 500 Hz sampling rate, with electrodes positioned at F3, F4, Fz, C3, C4, Cz, and Pz, referenced to the left earlobe (CMS) with the right mastoid as ground (DRL); a single-use ECG electrode will be placed on the lower left rib cage for heart rate and heartbeat-evoked potential (HEP) analysis. EEG preprocessing will include 0.5-45 Hz band-pass filtering, 50 Hz notch filtering, resampling to 250 Hz, bad channel interpolation, independent component analysis (ICA) for artifact removal, and rejection of epochs exceeding ±100 µV. Power spectral density will be calculated using Welch's method (2-second windows, 50% overlap). The primary outcome measures are sensorimotor mu rhythm power (C3, C4 channels) and posterior alpha power (Pz channel), reflecting cortical areas corresponding to TLF dermatomes. Secondary outcome measures include heart rate variability indices (RMSSD, LF/HF ratio), frontal alpha asymmetry, heartbeat-evoked potential (HEP) amplitude (Cz channel), and subjective ratings of local touch and back pain (VAS). Exploratory analyses will apply classical machine learning (SVM, Random Forest) and deep learning (EEGNet) models to classify pre- versus post-intervention EEG data and evaluate whether the active myofascial technique produces an EEG pattern distinguishable from the sham condition, beyond conventional group-mean comparisons. Sample size was determined via power analysis assuming a conservative small-to-moderate effect size (f = 0.225) for the between-group comparison, adjusted for an assumed baseline-to-follow-up correlation of r = 0.60 (effective f = 0.281 for the ANCOVA model). This yielded a required sample of 51 participants per group (102 total); accounting for an estimated 20% dropout rate, the target sample size was set at 62 participants per group (124 total). The primary statistical analysis will use an ANCOVA model (post-intervention value as the dependent variable; group, baseline value, sex, and physical activity level as fixed effects), following the intention-to-treat principle, with missing data handled via multiple imputation. A mixed-effects model (group × time interaction, participant as random effect) will be used as a secondary analysis, and a per-protocol analysis will be reported as a sensitivity analysis. Bonferroni correction will be applied to primary comparisons, and false discovery rate (FDR) correction to secondary and exploratory analyses; cluster-based permutation testing will be used for multichannel comparisons.

Interventions

OTHERThoracolumbar Fascia Myofascial Release (Pilat MIF Crossed-Hands Technique)

A manual myofascial release technique applied for 10 minutes to the thoracolumbar fascia (T10-L4 region) in the prone position. The therapist's hands are placed in a crossed configuration over the fascia, applying sustained moderate pressure (1.5-2.5 kg) without rapid movement, aiming to release tension in the fascia's laminar and posterior layers. The technique is delivered by a certified myofascial therapist trained in the Pilat Myofascial Induction (MIF) method.

OTHERSham (Light Surface Touch)

A sham condition consisting of light, static surface contact (\<0.5 kg) applied to the same thoracolumbar region as the active technique, for the same 10-minute duration and in the same prone position. No therapeutic pressure, sliding, or manipulation is applied. This condition controls for the effects of therapist contact, positioning, and expectation, isolating the specific effect of the myofascial release technique itself.

Sponsors

Hitit University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

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.

Intervention model description

Participants will be randomly assigned in a 1:1 ratio, using block randomization (block size 4) stratified by sex and physical activity level, to one of two parallel groups: an active treatment group receiving a 10-minute thoracolumbar fascia myofascial release technique, or a sham control group receiving light surface touch to the same region for the same duration without therapeutic pressure. Both groups will undergo identical EEG and ECG recordings at three time points - baseline, early post-intervention (0-10 minutes), and late post-intervention (30 minutes) - using a "sandwich protocol" in which baseline and post-intervention recordings are obtained in the supine position, with the intervention itself delivered in the prone position.

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
Yes

Inclusion criteria

* Age 18-25 years * Self-reported healthy status * Literate in Turkish

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in Sensorimotor Mu Rhythm Power (C3, C4 channels)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)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.

Secondary

MeasureTime frameDescription
Change in Heart Rate Variability - RMSSDBaseline, early post-intervention (0-10 min), late post-intervention (30 min)Root mean square of successive differences between normal heartbeats (RMSSD), an index of parasympathetic activation, calculated from ECG recordings.
Change in Heart Rate Variability - LF/HF RatioBaseline, early post-intervention (0-10 min), late post-intervention (30 min)Ratio of low-frequency to high-frequency power in heart rate variability, reflecting sympathovagal balance, calculated from ECG recordings.
Change in Frontal Alpha AsymmetryBaseline, early post-intervention (0-10 min), late post-intervention (30 min)Alpha power asymmetry between left and right frontal EEG channels (F3, F4), calculated as a log-transformed power ratio.
Change in Heartbeat-Evoked Potential (HEP) Amplitude (Cz channel)Baseline, early post-intervention (0-10 min), late post-intervention (30 min)Amplitude of the heartbeat-evoked potential, derived from EEG channel Cz time-locked to the R-peak of the ECG signal.
Change in Visual Analog Scale (VAS) Score for Local Touch SensationImmediately after the intervention; 24-hour follow-upParticipant-reported rating of local touch/pressure sensation at the treatment site, measured on a 0-10 or 0-100 mm Visual Analog Scale (VAS).
Change in Visual Analog Scale (VAS) Score for Back PainImmediately after the intervention; 24-hour follow-upParticipant-reported rating of back pain, measured on a 0-10 or 0-100 mm Visual Analog Scale (VAS).

Countries

Turkey (Türkiye)

Contacts

CONTACTEylem Küçük, Ph.D
eylem.kucuk@amasya.edu.tr+905067025859

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 30, 2026