PainfulNCT06950541
The Impact of Myofascial Therapy on Connective Tissue
A study testing Myofascial therapy and Deep Tissue Massage in people with Painful and Fascial Manipulation, run by Józef Piłsudski University of Physical Education at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Painful, Fascial Manipulation, Fascia
- What is being tested?
- Myofascial therapy and Deep Tissue Massage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 295 participants
- Where
- 1 sitePoland
- Study dates
- 3 Jul 2023to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- inflammatory changes in the examined areas of the body
- sensory disturbances in the examined body areas
- resignation from therapy
- changing the type of therapy
Trial locations and contacts
1 site in 1 country.
Poland1 site
Józef Piłsudski University of Physical Education in Warsaw
Warsaw, 00-968
About this study
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.
- Conditions
- Painful, Fascial Manipulation, Fascia, Pain, Myofascial Pain, Myofascial
- Being tested
- Myofascial therapy, Deep Tissue Massage
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial therapyProcedure or surgery
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.
Deep Tissue MassageProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Myofascial therapy | Experimental | Not described Receives: Procedure: Myofascial therapy |
| Deep Tissue Massage | Experimental | Not described Receives: Procedure: Deep Tissue Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the 7 days after last therapy.
Secondary outcomes (1)
Pain level
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.
Measured: From enrollment to the 7 days after last therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start3 Jul 2023
- Primary completion1 Jun 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for PainfulStudies 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
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- Józef Piłsudski University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrian Rogala, Józef Piłsudski University of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950541
- Sponsor's protocol ID
- JozefPilsudski_U
- Status last verified
- Apr 2025
- First submitted
- 18 Apr 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38476005Hughes 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.
PubMed 35244363Jha 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.
PubMed 35764475Hanson-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.
PubMed 33968546Kondrup 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.
PubMed 35417568Lariviere 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.
PubMed 36521728Wilke 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.
PubMed 30417344Asquini 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.
PubMed 34931336Clar 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.
PubMed 24679336Rogala 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.
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.
PubMed 35294051Cumplido-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.
PubMed 34537167Iogna 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.
PubMed 38217928Hyunjoong 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Myofascial Therapy on Connective Tissue
- ClinicalTrials.gov ID
- NCT06950541
- Acronym / sponsor ID
- JozefPilsudski_U
- Conditions
- Painful, Fascial Manipulation, Fascia, Pain, Myofascial Pain, Myofascial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- Józef Piłsudski University of Physical EducationUniversity, hospital or other
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 30 Apr 2025 (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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myofascial therapy | Experimental | Procedure: Myofascial therapy |
| Deep Tissue Massage | Experimental | Procedure: Deep Tissue Massage |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- undergone myofascial therapy
- undergone deep tissue massage
- patients with pain of musculoskeletal origin
- without contraindications to myofascial therapy
- without neurological diseases
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| Myofascial therapyThe 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. | Procedure or surgery | Myofascial therapy |
| Deep Tissue MassageA 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. | Procedure or surgery | Deep Tissue Massage |
Primary outcome
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.
1 secondary outcome
Pain level
Time frame: From enrollment to the 7 days after last therapy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Background: PubMed 38476005Pirri 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.
- Background: PubMed 35244363Hughes 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.
- Background: PubMed 35764475Jha 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.
- Background: PubMed 33968546Hanson-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.
- Background: PubMed 35417568Kondrup 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.
- Background: PubMed 36521728Lariviere 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.
- Background: PubMed 30417344Wilke 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.
- Background: PubMed 34931336Asquini 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.
- Background: PubMed 24679336Clar 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.
- BackgroundRogala 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.
- BackgroundRogala 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: PubMed 35294051Nunez-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.
- Anatomy, Fascia Layers; 2023Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofascial therapy and Deep Tissue Massage in people with Painful and Fascial Manipulation, run by Józef Piłsudski University of Physical Education at 1 site in Poland.
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 6 inclusion and 10 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: finished, as of the sponsor's last update on 30 Apr 2025. 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 Poland. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The thickness of the deep and superficial fascia. (time frame: From enrollment to the 7 days after last therapy.). 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 NCT06950541, which also lists 37 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 30 Apr 2025.