NCT06950541

Brief Summary

The study involved patients who suffered from myofascial pain caused occupational or sports overloads or muscle strains caused by sports or improper preparation for physical activity. The patients had not been previously treated for this reason. The only form of therapy was self-administered over-the-counter painkillers and ointments. Due to lack of relief, patients received one of two types of treatments, myofascial therapy or deep tissue massage. Each group was divided into three subgroups, depending on the location of the symptoms: arm, forearm, calf. The patients received three treatments on alternate days. Ultrasound imaging examination was performed by a physiotherapist, qualified to assess soft tissues using an USG. Two measurements were taken, before and seven days after therapy. To standardise the assessment, ultrasound imaging protocol was used. The thickness of the fascia was measured by ImageJ software. The aim of the study was an ultrasound imaging assessment of connective tissue of patients undergone myofascial therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
295

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 3, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 30, 2025

Completed
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

11 months

First QC Date

April 18, 2025

Last Update Submit

April 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • The thickness of the deep and superficial fascia.

    To assessed the thickness of the deep and superficial fascia, ultrasound imaging examination (USG) was performed by qualified physiotherapist. Two measurements were taken, before and seven days after therapy. Philips Affiniti 70G ultrasound device with linear probe (2-15 MHz) was used. To standardize the assessment, ultrasound imaging protocol described by Pirri et al. 2022 was used. To obtain more accurate results, the ultrasound image of the examined tissue was placed in the ImageJ ver. 1.54 software to assess the fascia thickness in millimetres.

    From enrollment to the 7 days after last therapy.

Secondary Outcomes (1)

  • Pain level

    From enrollment to the 7 days after last therapy.

Other Outcomes (1)

  • Body weight

    Once - upon enrollment

Study Arms (2)

Myofascial therapy

EXPERIMENTAL
Procedure: Myofascial therapy

Deep Tissue Massage

EXPERIMENTAL
Procedure: Deep Tissue Massage

Interventions

The myofascial therapy in the form of Fascial Distortion Model (FDM) method is based on the idea that issues within the musculoskeletal system stem from deformations or distortions in the fascia. Once the type of deformation is identified, a specific technique is employed by the physiotherapist using their hands and pressure. FDM identifies six types of fascial distortions that can cause pain and other musculoskeletal issues. These distortions include triggerbands, continuum distortions, cylinder distortions, herniated triggerpoints, tectonic fixations, and folding distortions.

Myofascial therapy

A deep tissue massage is a therapeutic technique that focuses on realigning deeper layers of muscles and connective tissue. It is particularly beneficial for individuals dealing with chronic pain, muscle tension, or injury recovery. The physiotherapist uses more intense pressure compared to other massage types, like Swedish massage. The goal is to reach deeper muscle layers to relieve tension and pain. The therapist employs various techniques, including long, slow strokes, deep finger pressure, and friction, also use elbows, knuckles, or forearms to apply pressure to specific areas.

Deep Tissue Massage

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • undergone myofascial therapy
  • undergone deep tissue massage
  • patients with pain of musculoskeletal origin
  • without contraindications to myofascial therapy
  • without neurological diseases
  • voluntary consent to participate in the study

You may not qualify if:

  • resignation from the study
  • lack of patient consent
  • cancers
  • disturbed continuity of skin tissue at the examination site
  • previous surgical procedures at the study site
  • large vascular changes
  • inflammatory changes in the examined areas of the body
  • sensory disturbances in the examined body areas
  • resignation from therapy
  • changing the type of therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Józef Piłsudski University of Physical Education in Warsaw

Warsaw, 00-968, Poland

Location

Related Publications (37)

  • Pirri C, Petrelli L, Guidolin D, Porzionato A, Fede C, Macchi V, De Caro R, Stecco C. Myofascial junction: Emerging insights into the connection between deep/muscular fascia and muscle. Clin Anat. 2024 Jul;37(5):534-545. doi: 10.1002/ca.24148. Epub 2024 Mar 12.

    PMID: 38476005BACKGROUND
  • Hughes E, Koenig J, Lee R, McDermott K, Freilicher T, Pitcher M. Pilot study assessing the effect of Fascial Manipulation on fascial densifications and associated pain. Eur J Transl Myol. 2022 Mar 3;32(1):10369. doi: 10.4081/ejtm.2022.10369.

    PMID: 35244363BACKGROUND
  • Jha DK, Wongkaewpotong J, Chuckpaiwong B. Effect of Age and BMI on Sonographic Findings of Plantar Fascia. J Foot Ankle Surg. 2023 Jan-Feb;62(1):125-128. doi: 10.1053/j.jfas.2022.05.010. Epub 2022 May 23.

    PMID: 35764475BACKGROUND
  • Hanson-Viana E, Rojas-Ortiz J, Rendon-Medina MA, Pacheco-Lopez RC, Rios-Lara Lopez LR, Palacios-Juarez J. Influence of BMI, Age, and Gender on the Thickness of Most Common Thinned Flaps. Plast Reconstr Surg Glob Open. 2021 Mar 30;9(3):e3409. doi: 10.1097/GOX.0000000000003409. eCollection 2021 Mar.

    PMID: 33968546BACKGROUND
  • Kondrup F, Gaudreault N, Venne G. The deep fascia and its role in chronic pain and pathological conditions: A review. Clin Anat. 2022 Jul;35(5):649-659. doi: 10.1002/ca.23882. Epub 2022 Apr 27.

    PMID: 35417568BACKGROUND
  • Lariviere C, Preuss R, Gagnon DH, Mecheri H, Driscoll M, Henry SM. The relationship between clinical examination measures and ultrasound measures of fascia thickness surrounding trunk muscles or lumbar multifidus fatty infiltrations: An exploratory study. J Anat. 2023 Apr;242(4):666-682. doi: 10.1111/joa.13807. Epub 2022 Dec 15.

    PMID: 36521728BACKGROUND
  • Wilke J, Macchi V, De Caro R, Stecco C. Fascia thickness, aging and flexibility: is there an association? J Anat. 2019 Jan;234(1):43-49. doi: 10.1111/joa.12902. Epub 2018 Nov 11.

    PMID: 30417344BACKGROUND
  • Asquini G, Pitance L, Michelotti A, Falla D. Effectiveness of manual therapy applied to craniomandibular structures in temporomandibular disorders: A systematic review. J Oral Rehabil. 2022 Apr;49(4):442-455. doi: 10.1111/joor.13299. Epub 2022 Jan 17.

    PMID: 34931336BACKGROUND
  • Clar C, Tsertsvadze A, Court R, Hundt GL, Clarke A, Sutcliffe P. Clinical effectiveness of manual therapy for the management of musculoskeletal and non-musculoskeletal conditions: systematic review and update of UK evidence report. Chiropr Man Therap. 2014 Mar 28;22(1):12. doi: 10.1186/2045-709X-22-12.

    PMID: 24679336BACKGROUND
  • Rogala A., Warzecha A., Turek G., Brzuszkiewicz-Kuźmicka G., Raźniak M., Dzierzęcki S., Ząbek M. The importance of manual therapy in occipital neuralgia - case study. BÓL. 2023; 24(1): 44-51. doi: 10.5604/01.3001.0053.4745.

    BACKGROUND
  • Rogala A., Brzuszkiewicz-Kuźmicka G. Influence of myofascial therapy on painful erection - case study. BÓL. 2020; 21(3): 54-59. doi: 10.5604/01.3001.0014.6060.

    BACKGROUND
  • Nunez-Cabaleiro P, Leiros-Rodriguez R. Effectiveness of manual therapy in the treatment of cervicogenic headache: A systematic review. Headache. 2022 Mar;62(3):271-283. doi: 10.1111/head.14278. Epub 2022 Mar 16.

    PMID: 35294051BACKGROUND
  • Cumplido-Trasmonte C, Fernandez-Gonzalez P, Alguacil-Diego IM, Molina-Rueda F. Manual therapy in adults with tension-type headache: A systematic review. Neurologia (Engl Ed). 2021 Sep;36(7):537-547. doi: 10.1016/j.nrleng.2017.12.005. Epub 2020 Apr 7.

    PMID: 34537167BACKGROUND
  • Iogna Prat P, Milan N, Huber J, Ridehalgh C. The effectiveness of nerve mechanical interface treatment for entrapment neuropathies in the limbs: A systematic review with metanalysis. Musculoskelet Sci Pract. 2024 Feb;69:102907. doi: 10.1016/j.msksp.2024.102907. Epub 2024 Jan 9.

    PMID: 38217928BACKGROUND
  • Hyunjoong K., Seungwon L. The Impact of Manual Therapy on Pain Catastrophizing in Chronic Pain Conditions: A Systematic Review and Meta-analysis. Phys Ther Rehabil Sci. 2023; 12(2): 177-184. doi: 10.14474/ptrs.2023.12.2.177

    BACKGROUND
  • Tamartash H, Bahrpeyma F, Dizaji MM. The Effect of Remote Myofascial Release on Chronic Nonspecific Low Back Pain With Hamstrings Tightness. J Sport Rehabil. 2023 Mar 16;32(5):549-556. doi: 10.1123/jsr.2022-0141. Print 2023 Jul 1.

    PMID: 36928003BACKGROUND
  • Ghorbanpour A., Shadmehr A., Moghaddam ST., Rasanani MH. The possibility of changes of brain activity following myofascial release in patients with nonspecific chronic low back pain: A hypothesis. Medical Hypotheses. 2023; 176: 111082. doi: 10.1016/j.mehy.2023.111082.

    BACKGROUND
  • Barassi G., Guerri S., Tavani R., Ricucci G., De Luca G., Rabini A., Di Iorio A. Ultrasonography in physiotherapy and rehabilitation. JAHC. 2021; 3(1). doi: 10.36017/jahc202131114

    BACKGROUND
  • Findley TW., Chaitow L., Huijing PA., Schleip R. Fascia: The Tensional Network of the Human Body. Elsevier 2012; 5 -57.

    BACKGROUND
  • Rogala A., Molik B., Brzuszkiewicz-Kuźmicka G., Truszczyńska-Baszak A. The impact of Fascial Distortion Model on Shoulder Girdle Dysfunction. Med Rehabil 2022; 26(2): 17-26. doi: 10.5604/01.3001.0015.8242

    BACKGROUND
  • Baird CJ., Shumate SM., Tancredi MP., Cayce LM., Wibbenmeyer JL. The effects of the fascial distortion model on chronic hamstring tightness. Topics in Integrative Health Care. 2014; 6(2): 1074-1086.

    BACKGROUND
  • LeeChan JK., Kim M. Comparison of Maximum Isometric Strength, Proprioceptive, Dynamic Balance, and Maximum Angle by Applying the Fascial Distortion Model to Chronic Ankle Instability Subjects. J Kor Phys Ther. 2021; 33(5): 224-230. doi: 10.18857/jkpt.2021.33.5.224

    BACKGROUND
  • Ghorbanpour A. Fascial Treatment in Frozen Shoulder: A Case Report. Journal of Modern Rehabilitation. 2019; 13(2): 123-128. doi: 10.32598/JMR.13.2.123

    BACKGROUND
  • Tozzi P., Chila A., Liem T. Fascia in the Osteopathic Field. Handspring Publishing Limited. 2017; 35: 360 -367

    BACKGROUND
  • Schulze C, Finze S, Bader R, Lison A. Treatment of medial tibial stress syndrome according to the fascial distortion model: a prospective case control study. ScientificWorldJournal. 2014;2014:790626. doi: 10.1155/2014/790626. Epub 2014 Oct 14.

    PMID: 25379543BACKGROUND
  • Stecco C, Pirri C, Fede C, Fan C, Giordani F, Stecco L, Foti C, De Caro R. Dermatome and fasciatome. Clin Anat. 2019 Oct;32(7):896-902. doi: 10.1002/ca.23408. Epub 2019 May 28.

    PMID: 31087420BACKGROUND
  • Pirri C, Stecco C, Petrelli L, De Caro R, Ozcakar L. Reappraisal on the Superficial Fascia in the Subcutaneous Tissue: Ultrasound and Histological Images Speaking Louder Than Words. Plast Reconstr Surg. 2022 Jul 1;150(1):244e-245e. doi: 10.1097/PRS.0000000000009224. Epub 2022 May 24. No abstract available.

    PMID: 35608834BACKGROUND
  • Pirri C, Stecco C, Pirri N, De Caro R, Ozcakar L. Ultrasound examination for a heel scar: seeing/treating the painful superficial fascia. Med Ultrason. 2022 May 25;24(2):255-256. doi: 10.11152/mu-3689.

    PMID: 35617618BACKGROUND
  • Pirri C, Pirri N, Guidolin D, Macchi V, De Caro R, Stecco C. Ultrasound Imaging of the Superficial Fascia in the Upper Limb: Arm and Forearm. Diagnostics (Basel). 2022 Aug 4;12(8):1884. doi: 10.3390/diagnostics12081884.

    PMID: 36010234BACKGROUND
  • Pirri C, Guidolin D, Fede C, Macchi V, De Caro R, Stecco C. Ultrasound Imaging of Brachial and Antebrachial Fasciae. Diagnostics (Basel). 2021 Dec 2;11(12):2261. doi: 10.3390/diagnostics11122261.

    PMID: 34943498BACKGROUND
  • Pirri C, Stecco A, Fede C, De Caro R, Stecco C, Ozcakar L. Ultrasound imaging of a scar on the knee: Sonopalpation for fascia and subcutaneous tissues. Eur J Transl Myol. 2020 Apr 1;30(1):8909. doi: 10.4081/ejtm.2019.8909. eCollection 2020 Apr 7.

    PMID: 32499900BACKGROUND
  • Pirri C, Stecco C, Fede C, Macchi V, Ozcakar L. Ultrasound Imaging of the Fascial Layers: You See (Only) What You Know. J Ultrasound Med. 2020 Apr;39(4):827-828. doi: 10.1002/jum.15148. Epub 2019 Oct 23. No abstract available.

    PMID: 31642543BACKGROUND
  • Pirri C, Fede C, Stecco A, Guidolin D, Fan C, De Caro R, Stecco C. Ultrasound Imaging of Crural Fascia and Epimysial Fascia Thicknesses in Basketball Players with Previous Ankle Sprains Versus Healthy Subjects. Diagnostics (Basel). 2021 Jan 26;11(2):177. doi: 10.3390/diagnostics11020177.

    PMID: 33530583BACKGROUND
  • Boucher JD, Figueroa J. Restoration of Full Shoulder Range of Motion After Application of the Fascial Distortion Model. J Am Osteopath Assoc. 2018 May 1;118(5):341-344. doi: 10.7556/jaoa.2018.044.

    PMID: 29507951BACKGROUND
  • Richter D, Karst M, Buhck H, Fink MG. Efficacy of Fascial Distortion Model Treatment for Acute, Nonspecific Low-Back Pain in Primary Care: A Prospective Controlled Trial. Altern Ther Health Med. 2017 Sep;23(5):AT5522. Epub 2017 Jun 23.

    PMID: 28646809BACKGROUND
  • Chaudhry H, Schleip R, Ji Z, Bukiet B, Maney M, Findley T. Three-dimensional mathematical model for deformation of human fasciae in manual therapy. J Am Osteopath Assoc. 2008 Aug;108(8):379-90. doi: 10.7556/jaoa.2008.108.8.379.

    PMID: 18723456BACKGROUND
  • Thalhamer C. A fundamental critique of the fascial distortion model and its application in clinical practice. J Bodyw Mov Ther. 2018 Jan;22(1):112-117. doi: 10.1016/j.jbmt.2017.07.009. Epub 2017 Jul 25.

    PMID: 29332733BACKGROUND

Related Links

MeSH Terms

Conditions

Pain

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 18, 2025

First Posted

April 30, 2025

Study Start

July 3, 2023

Primary Completion

June 1, 2024

Study Completion

July 31, 2024

Last Updated

April 30, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations