Acute Effects of Thoracolumbar Fascia Myofascial Release on Cortical Activity (MFR-EEG)

July 27, 2026 updated by: Ertugrul Deniz Kose, Hitit University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
      • Amasya, Turkey (Türkiye), 05100
        • Amasya University
        • Contact:
        • Principal Investigator:
          • Eylem Küçük, Ph.D
        • Sub-Investigator:
          • Ertuğrul Deniz Köse, Ph.D
        • Sub-Investigator:
          • Funda Kutlu Onay, Ph.D
        • Sub-Investigator:
          • Alpaslan Ersöz, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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."
Other: Thoracolumbar 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.
Sham Comparator: 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.
Other: Sham (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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Sensorimotor Mu Rhythm Power (C3, C4 channels)
Time Frame: 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.
Baseline (pre-intervention), early post-intervention (0-10 min), and late post-intervention (30 min)
Change in Posterior Alpha Power (Pz channel)
Time Frame: 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.
Baseline (pre-intervention), early post-intervention (0-10 min), and late post-intervention (30 min)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Heart Rate Variability - RMSSD
Time Frame: Baseline, 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.
Baseline, early post-intervention (0-10 min), late post-intervention (30 min)
Change in Heart Rate Variability - LF/HF Ratio
Time Frame: Baseline, 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.
Baseline, early post-intervention (0-10 min), late post-intervention (30 min)
Change in Frontal Alpha Asymmetry
Time Frame: Baseline, 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.
Baseline, early post-intervention (0-10 min), late post-intervention (30 min)
Change in Heartbeat-Evoked Potential (HEP) Amplitude (Cz channel)
Time Frame: 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.
Baseline, early post-intervention (0-10 min), late post-intervention (30 min)
Change in Visual Analog Scale (VAS) Score for Local Touch Sensation
Time Frame: Immediately after the intervention; 24-hour follow-up
Participant-reported rating of local touch/pressure sensation at the treatment site, measured on a 0-10 or 0-100 mm Visual Analog Scale (VAS).
Immediately after the intervention; 24-hour follow-up
Change in Visual Analog Scale (VAS) Score for Back Pain
Time Frame: Immediately after the intervention; 24-hour follow-up
Participant-reported rating of back pain, measured on a 0-10 or 0-100 mm Visual Analog Scale (VAS).
Immediately after the intervention; 24-hour follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hitit University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2028

Study Registration Dates

First Submitted

July 22, 2026

First Submitted That Met QC Criteria

July 22, 2026

First Posted (Actual)

July 27, 2026

Study Record Updates

Last Update Posted (Actual)

July 29, 2026

Last Update Submitted That Met QC Criteria

July 27, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Amasya Uni-Fascia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared. EEG and ECG recordings, questionnaire responses, and other study data will be stored securely and will be accessible only to the research team. Personal identifying information will be kept separate from the analysis dataset. Study findings will be reported in aggregate form in scientific publications, without disclosing any individual participant's identity or raw data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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