Healty VolunteersMFR-EEGNCT07728617
Acute Effects of Thoracolumbar Fascia Myofascial Release on Cortical Activity
A study testing Thoracolumbar Fascia Myofascial Release (Pilat MIF Crossed-Hands Technique) in people with Healty Volunteers, run by Hitit University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Healty Volunteers
- What is being tested?
- Thoracolumbar Fascia Myofascial Release (Pilat MIF Crossed-Hands Technique)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2026to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-25 years
- Self-reported healthy status
- Literate in Turkish
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Amasya University
Amasya, 05100
Eylem Küçük, Ph.D, +905067025859, eylem.kucuk@amasya.edu.tr
Eylem Küçük, Ph.D
About this study
Official title: 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.
Read the 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.
- Conditions
- Healty Volunteers
- Being tested
- Thoracolumbar Fascia Myofascial Release (Pilat MIF Crossed-Hands Technique), Sham (Light Surface Touch)
- Keywords
- Thoracolumbar fascia, Myofascial release, Electroencephalography, Sensorimotor Mu Rhythm, Cortical Activity, Sham-Controlled Trial, Heart Rate Variability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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." Receives: 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. Receives: Other: Sham (Light Surface Touch) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (pre-intervention), early post-intervention (0-10 min), and late post-intervention (30 min)
Secondary outcomes (6)
Change in Heart Rate Variability - RMSSD
Root mean square of successive differences between normal heartbeats (RMSSD), an index of parasympathetic activation, calculated from ECG recordings.
Measured: Baseline, early post-intervention (0-10 min), late post-intervention (30 min)
Change in Heart Rate Variability - LF/HF Ratio
Ratio of low-frequency to high-frequency power in heart rate variability, reflecting sympathovagal balance, calculated from ECG recordings.
Measured: Baseline, early post-intervention (0-10 min), late post-intervention (30 min)
Change in Frontal Alpha Asymmetry
Alpha power asymmetry between left and right frontal EEG channels (F3, F4), calculated as a log-transformed power ratio.
Measured: Baseline, early post-intervention (0-10 min), late post-intervention (30 min)
Change in Heartbeat-Evoked Potential (HEP) Amplitude (Cz channel)
Amplitude of the heartbeat-evoked potential, derived from EEG channel Cz time-locked to the R-peak of the ECG signal.
Measured: Baseline, early post-intervention (0-10 min), late post-intervention (30 min)
Change in Visual Analog Scale (VAS) Score for Local Touch Sensation
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).
Measured: Immediately after the intervention; 24-hour follow-up
Change in Visual Analog Scale (VAS) Score for Back Pain
Participant-reported rating of back pain, measured on a 0-10 or 0-100 mm Visual Analog Scale (VAS).
Measured: Immediately after the intervention; 24-hour follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Healty VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ertugrul Deniz Kose, Amasya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728617
- Sponsor's protocol ID
- Amasya Uni-Fascia
- Acronym
- MFR-EEG
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 8231161Wilke 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.
PubMed 28584816Schleip, 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
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
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.
PubMed 10576479Niddam 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
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.
PubMed 38157043Cheyne 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.
PubMed 22981841Castro-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.
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.
PubMed 36835784Brandl 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.
PubMed 34440589Paulo 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.
PubMed 34067152
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Thoracolumbar Fascia Myofascial Release Technique on Cortical Activity: A Sham-Controlled Randomized Study
- ClinicalTrials.gov ID
- NCT07728617
- Acronym / sponsor ID
- MFR-EEG / Amasya Uni-Fascia
- Conditions
- Healty Volunteers
- Keywords
- Thoracolumbar fascia, Myofascial release, Electroencephalography, Sensorimotor Mu Rhythm, Cortical Activity, Sham-Controlled Trial, Heart Rate Variability
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: Thoracolumbar Fascia Myofascial Release | Experimental | Other: Thoracolumbar Fascia Myofascial Release (Pilat MIF Crossed-Hands Technique)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." |
| Arm 2 - Sham Comparator: Light Surface Touch (Control) | Sham comparator | Other: Sham (Light Surface Touch)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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-25 years
- Self-reported healthy status
- Literate in Turkish
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Active Comparator: Thoracolumbar Fascia Myofascial Release |
| 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. | Other | Arm 2 - Sham Comparator: Light Surface Touch (Control) |
Primary outcome
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.
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.
6 secondary outcomes
Change in Heart Rate Variability - RMSSD
Time frame: 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)
Change in Frontal Alpha Asymmetry
Time frame: 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)
Change in Visual Analog Scale (VAS) Score for Local Touch Sensation
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Background: PubMed 8231161Yahia 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.
- Background: PubMed 28584816Wilke 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.
- BackgroundSchleip, 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
- BackgroundSchleip, 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: PubMed 10576479Pfurtscheller 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.
- BackgroundNiddam 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: PubMed 38157043Ketelhut 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.
- Background: PubMed 22981841Cheyne 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.
- BackgroundCastro-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: PubMed 36835784Brandl 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.
- Background: PubMed 34440589Brandl 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.
- Background: PubMed 34067152Paulo 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracolumbar Fascia Myofascial Release (Pilat MIF Crossed-Hands Technique) in people with Healty Volunteers, run by Hitit University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eylem Küçük, Ph.D (+905067025859, eylem.kucuk@amasya.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07728617, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.