Acute Effects of Thoracolumbar Fascia Myofascial Release on Cortical Activity

NCT07728617 | Not Yet Recruiting

• 1 other identifier: Amasya Uni-Fascia
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Healty Volunteers

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change in Sensorimotor Mu Rhythm Power (C3, C4 channels)

  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)

  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 Outcomes (6)

• 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

Study Arms (2)

Active Comparator: Thoracolumbar Fascia Myofascial Release

EXPERIMENTAL

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)

Arm 2 - Sham Comparator: Light Surface Touch (Control)

SHAM COMPARATOR

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)

Interventions

Thoracolumbar Fascia Myofascial Release (Pilat MIF Crossed-Hands Technique) OTHER

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.

Active Comparator: Thoracolumbar Fascia Myofascial Release

Sham (Light Surface Touch) OTHER

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.

Arm 2 - Sham Comparator: Light Surface Touch (Control)

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hitit University: lead

Study Sites (1)

Amasya University

Amasya, 05100, Turkey (Türkiye)

Location

Related Publications (12)

• Yahia LH, Pigeon P, DesRosiers EA. Viscoelastic properties of the human lumbodorsal fascia. J Biomed Eng. 1993 Sep;15(5):425-9. doi: 10.1016/0141-5425(93)90081-9.

  PMID: 8231161 BACKGROUND

• Wilke J, Schleip R, Klingler W, Stecco C. The Lumbodorsal Fascia as a Potential Source of Low Back Pain: A Narrative Review. Biomed Res Int. 2017;2017:5349620. doi: 10.1155/2017/5349620. Epub 2017 May 11.

  PMID: 28584816 BACKGROUND

• Schleip, R. (2003b). Fascial plasticity-A new neurobiological explanation: Part 2. Journal of Bodywork and Movement Therapies, 7(2), 104-116. https://doi.org/10.1016/S1360-8592(02)00076-1

  BACKGROUND

• Schleip, R. (2003a). Fascial plasticity-A new neurobiological explanation: Part 1. Journal of Bodywork and Movement Therapies, 7(1), 11-19. https://doi.org/10.1016/S1360-8592(02)00067-0

  BACKGROUND

• Pfurtscheller G, Lopes da Silva FH. Event-related EEG/MEG synchronization and desynchronization: basic principles. Clin Neurophysiol. 1999 Nov;110(11):1842-57. doi: 10.1016/s1388-2457(99)00141-8.

  PMID: 10576479 BACKGROUND

• Niddam DM, et al. (2023). The possibility of changes of brain activity following myofascial release in patients with nonspecific chronic low back pain: A hypothesis. Medical Hypotheses. DOI: 10.1016/j.mehy.2023.111046

  BACKGROUND

• Ketelhut S, Oechslin L, Zehnder C, Kubica C, Nigg CR. Acute self-myofascial release modulates cardiac autonomic function and hemodynamic parameters at rest and reduces cardiovascular stress reaction. Eur J Appl Physiol. 2024 May;124(5):1535-1545. doi: 10.1007/s00421-023-05382-2. Epub 2023 Dec 29.

  PMID: 38157043 BACKGROUND

• Cheyne DO. MEG studies of sensorimotor rhythms: a review. Exp Neurol. 2013 Jul;245:27-39. doi: 10.1016/j.expneurol.2012.08.030. Epub 2012 Sep 7.

  PMID: 22981841 BACKGROUND

• Castro-Sánchez AM, et al. (NCT02067494). Myofascial Release and Kinesiotaping on Disability, Pain, Autonomic Nervous System and Oxidative Stress Indicators in Chronic Low Back Pain: A Randomized Controlled Clinical Trial. Universidad de Almería.

  BACKGROUND

• Brandl A, Egner C, Reer R, Schmidt T, Schleip R. Immediate Effects of Myofascial Release Treatment on Lumbar Microcirculation: A Randomized, Placebo-Controlled Trial. J Clin Med. 2023 Feb 4;12(4):1248. doi: 10.3390/jcm12041248.

  PMID: 36835784 BACKGROUND

• Brandl A, Egner C, Schleip R. Immediate Effects of Myofascial Release on the Thoracolumbar Fascia and Osteopathic Treatment for Acute Low Back Pain on Spine Shape Parameters: A Randomized, Placebo-Controlled Trial. Life (Basel). 2021 Aug 18;11(8):845. doi: 10.3390/life11080845.

  PMID: 34440589 BACKGROUND

• Paulo LR, Lacerda ACR, Martins FLM, Fernandes JSC, Vieira LS, Guimaraes CQ, Ballesteros SSG, Anjos MTSD, Tavares PA, Fonseca SFD, Oliveira MX, Bernardo-Filho M, Sa-Caputo DDC, Mendonca VA, Taiar R. Can a Single Trial of a Thoracolumbar Myofascial Release Technique Reduce Pain and Disability in Chronic Low Back Pain? A Randomized Balanced Crossover Study. J Clin Med. 2021 May 7;10(9):2006. doi: 10.3390/jcm10092006.

  PMID: 34067152 BACKGROUND

MeSH Terms

Interventions

salicylhydroxamic acid

Central Study Contacts

Eylem Küçük, Ph.D

CONTACT

+905067025859; eylem.kucuk@amasya.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof. Dr.

Model Details: 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.

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 27, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)