Low Back Pain, MechanicalNCT06715969
Comparison of Two Different Fascial Treatments
A study testing Myofascial Release Techniques, Myofascial Induction Techniques and classıcal phsyotherapy in people with Low Back Pain, Mechanical, run by Doğan Burak Endamli at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the different effects of two different fascial treatments on pain, flexibility and Asian architecture. 2 different groups 8 sessions, two different fascial treatments will be applied in accordance with the intake criteria, the individuals will be re-evaluated before the treatment… Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Mechanical
- What is being tested?
- Myofascial Release Techniques, Myofascial Induction Techniques and classıcal phsyotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2024to 15 Apr 2025
- 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 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients between 35-60 years old
- Patients with low back pain for at least 3 months
- Patients with pain 4 and above according to VAS
- Having not received FTR and manual therapy for the last 3 months
- Those who have not received medical treatment for the last 3 months and those who will not
Who cannot join
- Those with a history of back and spine surgery
- Patients with a history of trauma
- Those with instable neurological findings
- Having a pathology such as hernia and root pressure in the lumbal region
- Regular users of analgesic and anti-inflammatory drugs
- Communication problem that will prevent the implementation of evaluations and/or treatment program
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
MMT Amerikan tıp merkezi
Gaziantep, sehitkamil, 27100
About this study
Official title: Comparison of the Effects of Myofascial Release and Fascial Induction Therapy Techniques on Pain, Flexibility and Fascial Architecture.
The aim of this study is to compare the different effects of two different fascial treatments on pain, flexibility and Asian architecture.
2 different groups 8 sessions, two different fascial treatments will be applied in accordance with the intake criteria, the individuals will be re-evaluated before the treatment, after 8 sessions of treatment and 3 months after the end of the study.
Read the detailed description
Chronic low back pain is a disease that causes the loss of working days in the world, causes significant disability and health costs, and cannot be fully diagnosed. It ranks second among the job loss factors and is considered the most important factor affecting the decline in production.
Until recent years, conservative treatment of all types of low back pain included bed rest for a certain period of time. This situation has changed over time with studies, and today's treatment is to gradually increase the level of activity according to the person's level with minimal bed rest.
Chronic low back pain is seen as a disorder that 70% of people can experience at least once in their lives. Today, it is one of the most common and expensive syndromes of modern times, reaching a rate of 80% in Europe. The participants experiencing the negative effects of chronic low back pain has disadvantages such as health and medical research expenses for the community, while experiencing pain, decreased daily living activities, decreased work productivity or disappearance.
There are no regional, national and international guidelines for the treatment of chronic low back pain. There is no strong recommendation for a specific physiotherapy approach yet. Studies to understand the pathophysiological mechanisms that lead to this focus on the structural pathology of the spine and related tissues, neuropsychosocial factors and motor control abnormalities. On the other hand, the fascia of the lumbal region received little attention.
Several researchers have suggested that fascias may play a role in the pathophysiology of LBP. In one study, it was seen that the thoracolumbal fascia (TLF) was thicker in the ultrasound image of people who experienced LBP than in normal people. Recent studies have shown a relationship between LBP and facial tissue. However, there is no treatment program for this.
Each body structure is surrounded by fascia, and for every tissue and organ, fascias form and create a continuity that provides function. Each region of the human body should be accepted as a functional unit in communication with each other with the fascial continuity. Facial tissue is evenly distributed and interacts with nerves and veins in particular. It forms layers in the depths of internal organs, bones and muscles and forms a three-dimensional mechanical and metabolic matrix. Therefore, the fascia becomes an organ that can affect a person's health. The continuity of the fascia in the body and the mechanical role of fibroblasts, the ability to communicate with each other, strengthens the belief that the fascia has a similar integration in the nervous system.
The Myofascial Release Technique (MFR) is one of the manual techniques used to increase the lengthenability of soft tissues or to restore normal length in limited fascia or muscles by providing a continuous stretch or compression to target tissues. MFR method is a method applied under the skin without slipping on the skin. The face matrix responds to 4 mechanoreceptors (golgi, paccini, ruffini and intersitial). The MFR stimulates these mechanoreceptors by increasing the awareness of touch and kinesthetics, applying pressure-sensitive techniques, and then applying constant pressure to release the restricted fascia. As the tissue relaxes, it stretches and the patient begins to loosen on its own, other mechanical receptors are stimulated by this movement. The MFR also allows collagen and elastin fibers to be rearranged to a more suitable resting length by applying biomechanical energy or by pressure from energy.
Myofacial Induction Technique (MIT) is a method used in physiotherapy that focuses on the restoration of modified phased tissues. In a healthy body, the facial system provides flexibility and coordination of movements. With MIT, the healing of a region is achieved by changing the tissue dynamics due to the mechanical tension of the region. Fascia acts as a space-sensitive system. During treatment, the clinic stretches or compresses a specific body area to transmit a low-intensity mechanical stimulation. This input creates changes that spread to body systems at the molecular level. Chemically, metabolic and physiologically, it creates mutual reactions in the body. MIT is a therapy concept that focuses on optimizing function and balance within the facial system. The approach aims at local healing, improving global dynamics and painless body use. The treatment protocol is divided into 2 stages, superficial techniques and deep procedures. Surface procedures are intended for surface and/or local restrictions that can be directly detected by palpation. Deep myofascial induction treatment, on the other hand, is a method that eliminates the limitations of the movements applied to the myofascial system and the pressures used in three dimensions.
When the literature was examined, fascia treatments in people with chronic low back pain were investigated, it was found to be effective, but it was found that more than one technique was not compared. In addition, the instantaneous or short-term effects of fascia treatments have always been taken into account. In addition, the information that the tocolumbal fascia surrounds many muscles and also covers them has been neglected. These limitations have led us to do this job. In the light of this information, the aim of our study is to determine the most effective fascia treatment and to present the literature as a result of the treatments of people with chronic low back pain in Gaziantep.
Our study will be planned as a randomized controlled study. Our most legal goal is that our treatment method applied manually in our study is morphological changes in the body by looking at it with ultrasound. It is predicted that our study will shed light on the studies to be carried out on fascial therapies, which have come to the fore in the last few years and whose importance is increasing every year.
- Conditions
- Low Back Pain, Mechanical
- Being tested
- Myofascial Release Techniques, Myofascial Induction Techniques, classıcal phsyotherapy
- Keywords
- low back pain, ultrasound, toracolumbal fascia
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial Release TechniquesOther
Separate techniques will be applied to the parts of the thoracolumbal fascia that surround the erector spina, quadratus lumborum, latissimus dorsi muscles and extend in that direction to patients in the MFR group. Techniques will continue for 180 seconds, tissue shift will be carried further as relaxation is achieved. Applications Total 8 sessions will be applied twice a week by an experienced physiotherapist.
Myofascial Induction TechniquesOther
MIT will be applied to the lumbal region by a physiotherapist trained and experienced in fascial treatments to patients in the MIT group. Applications 2 sessions per week, a total of 8 sessions will be applied, with an average of 20-25 minutes. The application principles of this technique will be as follows.
- Induction of the lumbal interfacial triangle region (stroke application) (3 min)
- Induction of the lumbal interfacial triangle region (deep induction application) (3 min)
- Cross-hands myofascial induction (3 min)
classıcal phsyotherapyOther
15 sessions of mictowave diathermy (MDD), Vacuum Interference, Infraruj and Classic waist exercise program will be applied to patients in this group.
| Study group | Role | What they receive |
|---|---|---|
| myofasyal indiction treatment | Active comparator | MIT will be applied to the lumbal region by a physiotherapist trained and experienced in fascial treatments to patients in the MIT group. Applications 2 sessions per week, a total of 8 sessions will be applied, with an average of 20-25 minutes. The application principles of this technique will be as follows.
* Induction of the lumbal interfacial triangle region (stroke application) (3 min)
* Induction of the lumbal interfacial triangle region (deep induction application) (3 min)
* Cross-hands myofascial induction (3 min) Receives: Other: Myofascial Induction Techniques |
| classıcal phsyotherapy | Active comparator | 15 sessions of mictowave diathermy (MDD), Vacuum Interference, Infraruj and Classic waist exercise program will be applied to patients in this group. Receives: Other: classıcal phsyotherapy |
| Myofacial ReleaseTechniques | Active comparator | Separate techniques will be applied to the parts of the thoracolumbal fascia that surround the erector spina, quadratus lumborum, latissimus dorsi muscles and extend in that direction to patients in the MFR group. Techniques will continue for 180 seconds, tissue shift will be carried further as relaxation is achieved. Applications Total 8 sessions will be applied twice a week by an experienced physiotherapist. Receives: Other: Myofascial Release Techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
We expect a decrease in pain at the end of 4 weeks. We expect a decrease in the value of the visual analog scale (VAS). According to this scale, it shows 10 very severe pains and 0 pains. We look at the VAS values of people both before and after the study.
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start15 Nov 2024
- Primary completion15 Dec 2024 (estimated)
- Study completion15 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back Pain, MechanicalStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Myofascial release will be applied to one group, miofascial induction treatment will be applied to the other group.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Doğan Burak Endamli
- Sponsor type
- University, hospital or other
- Collaborators
- Hasan Kalyoncu University
- Responsible party
- Sponsor-investigator, Doğan Burak Endamli, Hasan Kalyoncu University
- Investigators
- kezban bayramlar, profesör, Study director, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715969
- Sponsor's protocol ID
- HasanKalyon
- Status last verified
- Oct 2024
- First submitted
- 19 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chamorro Comesana A, Suarez Vicente MD, Docampo Ferreira T, Perez-La Fuente Varela MD, Porto Quintans MM, Pilat A. Effect of myofascial induction therapy on post-c-section scars, more than one and a half years old. Pilot study. J Bodyw Mov Ther. 2017 Jan;21(1):197-204. doi: 10.1016/j.jbmt.2016.07.003. Epub 2016 Jul 18.
PubMed 28167179
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Myofascial Release and Fascial Induction Therapy Techniques on Pain, Flexibility and Fascial Architecture.
- ClinicalTrials.gov ID
- NCT06715969
- Acronym / sponsor ID
- HasanKalyon
- Conditions
- Low Back Pain, Mechanical
- Keywords
- low back pain, ultrasound, toracolumbal fascia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Doğan Burak EndamliUniversity, hospital or other
- Collaborators
- Hasan Kalyoncu University
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 15 Apr 2025 (estimated)
- First posted
- 4 Dec 2024 (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 aim of this study is to compare the different effects of two different fascial treatments on pain, flexibility and Asian architecture.
2 different groups 8 sessions, two different fascial treatments will be applied in accordance with the intake criteria, the individuals will be re-evaluated before the treatment, after 8 sessions of treatment and 3 months after the end of the study.
Detailed description
Chronic low back pain is a disease that causes the loss of working days in the world, causes significant disability and health costs, and cannot be fully diagnosed. It ranks second among the job loss factors and is considered the most important factor affecting the decline in production.
Until recent years, conservative treatment of all types of low back pain included bed rest for a certain period of time. This situation has changed over time with studies, and today's treatment is to gradually increase the level of activity according to the person's level with minimal bed rest.
Chronic low back pain is seen as a disorder that 70% of people can experience at least once in their lives. Today, it is one of the most common and expensive syndromes of modern times, reaching a rate of 80% in Europe. The participants experiencing the negative effects of chronic low back pain has disadvantages such as health and medical research expenses for the community, while experiencing pain, decreased daily living activities, decreased work productivity or disappearance.
There are no regional, national and international guidelines for the treatment of chronic low back pain. There is no strong recommendation for a specific physiotherapy approach yet. Studies to understand the pathophysiological mechanisms that lead to this focus on the structural pathology of the spine and related tissues, neuropsychosocial factors and motor control abnormalities. On the other hand, the fascia of the lumbal region received little attention.
Several researchers have suggested that fascias may play a role in the pathophysiology of LBP. In one study, it was seen that the thoracolumbal fascia (TLF) was thicker in the ultrasound image of people who experienced LBP than in normal people. Recent studies have shown a relationship between LBP and facial tissue. However, there is no treatment program for this.
Each body structure is surrounded by fascia, and for every tissue and organ, fascias form and create a continuity that provides function. Each region of the human body should be accepted as a functional unit in communication with each other with the fascial continuity. Facial tissue is evenly distributed and interacts with nerves and veins in particular. It forms layers in the depths of internal organs, bones and muscles and forms a three-dimensional mechanical and metabolic matrix. Therefore, the fascia becomes an organ that can affect a person's health. The continuity of the fascia in the body and the mechanical role of fibroblasts, the ability to communicate with each other, strengthens the belief that the fascia has a similar integration in the nervous system.
The Myofascial Release Technique (MFR) is one of the manual techniques used to increase the lengthenability of soft tissues or to restore normal length in limited fascia or muscles by providing a continuous stretch or compression to target tissues. MFR method is a method applied under the skin without slipping on the skin. The face matrix responds to 4 mechanoreceptors (golgi, paccini, ruffini and intersitial). The MFR stimulates these mechanoreceptors by increasing the awareness of touch and kinesthetics, applying pressure-sensitive techniques, and then applying constant pressure to release the restricted fascia. As the tissue relaxes, it stretches and the patient begins to loosen on its own, other mechanical receptors are stimulated by this movement. The MFR also allows collagen and elastin fibers to be rearranged to a more suitable resting length by applying biomechanical energy or by pressure from energy.
Myofacial Induction Technique (MIT) is a method used in physiotherapy that focuses on the restoration of modified phased tissues. In a healthy body, the facial system provides flexibility and coordination of movements. With MIT, the healing of a region is achieved by changing the tissue dynamics due to the mechanical tension of the region. Fascia acts as a space-sensitive system. During treatment, the clinic stretches or compresses a specific body area to transmit a low-intensity mechanical stimulation. This input creates changes that spread to body systems at the molecular level. Chemically, metabolic and physiologically, it creates mutual reactions in the body. MIT is a therapy concept that focuses on optimizing function and balance within the facial system. The approach aims at local healing, improving global dynamics and painless body use. The treatment protocol is divided into 2 stages, superficial techniques and deep procedures. Surface procedures are intended for surface and/or local restrictions that can be directly detected by palpation. Deep myofascial induction treatment, on the other hand, is a method that eliminates the limitations of the movements applied to the myofascial system and the pressures used in three dimensions.
When the literature was examined, fascia treatments in people with chronic low back pain were investigated, it was found to be effective, but it was found that more than one technique was not compared. In addition, the instantaneous or short-term effects of fascia treatments have always been taken into account. In addition, the information that the tocolumbal fascia surrounds many muscles and also covers them has been neglected. These limitations have led us to do this job. In the light of this information, the aim of our study is to determine the most effective fascia treatment and to present the literature as a result of the treatments of people with chronic low back pain in Gaziantep.
Our study will be planned as a randomized controlled study. Our most legal goal is that our treatment method applied manually in our study is morphological changes in the body by looking at it with ultrasound. It is predicted that our study will shed light on the studies to be carried out on fascial therapies, which have come to the fore in the last few years and whose importance is increasing every year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Myofascial release will be applied to one group, miofascial induction treatment will be applied to the other group.
| Arm | Type | Receives |
|---|---|---|
| myofasyal indiction treatment | Active comparator | Other: Myofascial Induction TechniquesMIT will be applied to the lumbal region by a physiotherapist trained and experienced in fascial treatments to patients in the MIT group. Applications 2 sessions per week, a total of 8 sessions will be applied, with an average of 20-25 minutes. The application principles of this technique will be as follows. * Induction of the lumbal interfacial triangle region (stroke application) (3 min) * Induction of the lumbal interfacial triangle region (deep induction application) (3 min) * Cross-hands myofascial induction (3 min) |
| classıcal phsyotherapy | Active comparator | Other: classıcal phsyotherapy15 sessions of mictowave diathermy (MDD), Vacuum Interference, Infraruj and Classic waist exercise program will be applied to patients in this group. |
| Myofacial ReleaseTechniques | Active comparator | Other: Myofascial Release TechniquesSeparate techniques will be applied to the parts of the thoracolumbal fascia that surround the erector spina, quadratus lumborum, latissimus dorsi muscles and extend in that direction to patients in the MFR group. Techniques will continue for 180 seconds, tissue shift will be carried further as relaxation is achieved. Applications Total 8 sessions will be applied twice a week by an experienced physiotherapist. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients between 35-60 years old
- Patients with low back pain for at least 3 months
- Patients with pain 4 and above according to VAS
- Having not received FTR and manual therapy for the last 3 months
- Those who have not received medical treatment for the last 3 months and those who will not
Key exclusion criteria (6 listed)
- Those with a history of back and spine surgery
- Patients with a history of trauma
- Those with instable neurological findings
- Having a pathology such as hernia and root pressure in the lumbal region
- Regular users of analgesic and anti-inflammatory drugs
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 Release TechniquesSeparate techniques will be applied to the parts of the thoracolumbal fascia that surround the erector spina, quadratus lumborum, latissimus dorsi muscles and extend in that direction to patients in the MFR group. Techniques will continue for 180 seconds, tissue shift will be carried further as relaxation is achieved. Applications Total 8 sessions will be applied twice a week by an experienced physiotherapist. | Other | Myofacial ReleaseTechniques |
| Myofascial Induction TechniquesMIT will be applied to the lumbal region by a physiotherapist trained and experienced in fascial treatments to patients in the MIT group. Applications 2 sessions per week, a total of 8 sessions will be applied, with an average of 20-25 minutes. The application principles of this technique will be as follows. * Induction of the lumbal interfacial triangle region (stroke application) (3 min) * Induction of the lumbal interfacial triangle region (deep induction application) (3 min) * Cross-hands myofascial induction (3 min) | Other | myofasyal indiction treatment |
| classıcal phsyotherapy15 sessions of mictowave diathermy (MDD), Vacuum Interference, Infraruj and Classic waist exercise program will be applied to patients in this group. | Other | classıcal phsyotherapy |
Primary outcome
pain
Time frame: From enrollment to the end of treatment at 4 weeks
We expect a decrease in pain at the end of 4 weeks. We expect a decrease in the value of the visual analog scale (VAS). According to this scale, it shows 10 very severe pains and 0 pains. We look at the VAS values of people both before and after the study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Background: PubMed 28167179Chamorro Comesana A, Suarez Vicente MD, Docampo Ferreira T, Perez-La Fuente Varela MD, Porto Quintans MM, Pilat A. Effect of myofascial induction therapy on post-c-section scars, more than one and a half years old. Pilot study. J Bodyw Mov Ther. 2017 Jan;21(1):197-204. doi: 10.1016/j.jbmt.2016.07.003. Epub 2016 Jul 18.
- 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.
kezban bayramlar, profesör study director
Hasan Kalyoncu University
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 Release Techniques, Myofascial Induction Techniques and classıcal phsyotherapy in people with Low Back Pain, Mechanical, run by Doğan Burak Endamli 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 4 Dec 2024. 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. 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?
Results are not available in the source record.
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?
pain (time frame: From enrollment to the end of treatment at 4 weeks). 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 NCT06715969, which also lists 1 linked publication.
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 4 Dec 2024.