- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06950541
The Impact of Myofascial Therapy on Connective Tissue
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Warsaw, Poland, 00-968
- Józef Piłsudski University of Physical Education in Warsaw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Myofascial therapy
|
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.
|
|
Experimental: Deep Tissue Massage
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The thickness of the deep and superficial fascia.
Time Frame: From enrollment to the 7 days after last therapy.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain level
Time Frame: From enrollment to the 7 days after last therapy.
|
To assess the pain level, Visual Analogue Scale (VAS) was used.
It is a simple but valuable instrument that measure a level of pain, by range across a continuum of values and cannot easily be directly measured.
The scale is a horizontal line, 100 mm in length, anchored by word descriptors at each end, that represent the severity of symptoms from 0 "no symptoms" to 10 "very severe symptoms."
The patient marked on the line the point that the patient believed represents his or her perception of his or her current state.
|
From enrollment to the 7 days after last therapy.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body weight
Time Frame: Once - upon enrollment
|
A digital scale was used to assess the patients' body weight.
The unit of measurement used in the study was kilograms.
|
Once - upon enrollment
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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
- Findley TW., Chaitow L., Huijing PA., Schleip R. Fascia: The Tensional Network of the Human Body. Elsevier 2012; 5 -57.
- 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
- 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.
- 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
- 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
- Tozzi P., Chila A., Liem T. Fascia in the Osteopathic Field. Handspring Publishing Limited. 2017; 35: 360 -367
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- JozefPilsudski_U
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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