Low Back Pain, MechanicalEarly Phase 1NCT03738306
Mézières Method in People With Low Back Pain.
A Early Phase 1 study testing Mezieres Method and Conventional Physiotherapy in people with Low Back Pain, Mechanical, run by Universidad de la Sabana.
Trial summary
The Mezieres method was born in France with the physiotherapist Francoiçe Mezieres, who in the middle of the previous century began a series of observations that led her to rediscover body characteristics to understand it in a revolutionary way. Read more about this study
- Who is it for?
- Ages 19 to 64 years
- Conditions the study is for
- Low Back Pain, Mechanical
- What is being tested?
- Mezieres Method and Conventional Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Feb 2019to Feb 2021
- Phase
- Early Phase 1
- 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 19 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- People with low back pain (LBP) (mechanical)
- people with LBP of at least three months
- people with LBP with a requirement from medicine to be treated by physiotherapy
- people with Roland Morris Questionnaire major to 4.
Who cannot join
- Anamnesis with red flags related with low back pain
- signs of lumbar pain associated with compression or radicular injury
- shortening of the lower limb or any mechanical modification that affects the lumbopelvic complex.
- post-surgery of the spine
- symptoms of depression or emotional risk factors that worsen the clinical
Trial locations and contacts
No sites are listed yet.
Adriana L Castellanos-Garrido, Mg contact
About this study
Official title: Mézières Method for "The Use of Self" in People With Low Back Pain. Mixed Study.
The Mezieres method was born in France with the physiotherapist Francoiçe Mezieres, who in the middle of the previous century began a series of observations that led her to rediscover body characteristics to understand it in a revolutionary way. Among the most important contributions is the first description of muscle chains, from which different global physiotherapy techniques have emerged. The method also proposes a form of intercorporal relationship different from that used in classical physiotherapy and gives way for people who receive this treatment to improve their body disposition and make use of their body in a conscientious manner. From this, in the present study we try to understand this method as one of the ones that promotes the "Use of self". In addition to identifying other aspects related to the meaning of the corporal intersubjectivity for the physiotherapist and for the person being treated, looking for the subjective construction of effectiveness and determining the objective effectiveness by means of objective measurements of the body.
The present research project use a mix method, it aims quantify the bodily benefits when applying the method and understand from the subjectivity the implications for the self during the body activity of the Mezieres Method. The study will be mixed and in parallel with 82 people diagnosed with mechanical back pain. Three assessments will be made: one initial, one at the end of the intervention and one last follow-up six weeks after the end of the treatment. The tests to be used will assess pain, functional limitation related to low back pain, quality of life related to health, flexibility, range of motion and posture. For the intervention, participants will be divided into 2 groups, group one will receive Method Mézières and group two will receive conventional physiotherapy according to the protocols of a clinical institution in Bogotá. Parallel to the intervention, the participating individuals and physiotherapists will keep a field diary that will facilitate the understanding of the body experience by performing the method studied.
At the end of the study, it is intended to know the objective effectiveness by means of the comparison made in the two groups in the variables studied. In addition, an interpretation of the body experience is expected when performing the Mezieres Method in comparison with conventional physiotherapy. This interpretation of hermeneutic character will revolve around the theoretical construction of the "Use of self"; This concept is recognized as a technology of the self that will be pursued through the Mézières Method. By promoting the "Use of self" the person can recognize their body and appropriate what happens with their locomotor system, decreasing the symptoms of pain and improving the prognosis of care for people who have these symptoms.
- Conditions
- Low Back Pain, Mechanical
- Being tested
- Mezieres Method, Conventional Physiotherapy
- 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.
Mezieres MethodOther
"The Mézières treatment have 3 postures that could be adapted to each patient, depending on his/her needs to correct variations in the dorsal curve and promote diaphragmatic breathing. The first objective was to recover extensibility of the hypertonic muscle groups and, in particular, those in the low back muscular chain: the paravertebral muscles and latissimus dorsi".
Conventional PhysiotherapyOther
therapeutic exercise; physical agents
| Study group | Role | What they receive |
|---|---|---|
| Mezieres Method | Experimental | The Mézières treatment has 3 postures that could be adapted to each patient, depending on his/her needs to correct variations in the dorsal curve and promote diaphragmatic breathing. The first objective was to recover extensibility of the hypertonic muscle groups and, in particular, those in the low back muscular chain. The time of tratment will be of 1 hour, two times a week, during 5 weeks. Receives: Other: Mezieres Method |
| Conventional Physiotherapy | Active comparator | The treatment with conventional physiotherapy will include stretching of hamstrings, gluteus, (and others) hot pack, transcutaneous electrical nerve stimulation, ultrasound and some exercises of core performance.The time of treatment will be of 1 hour, two times a week, during 5 weeks. Receives: Other: Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Roland Morris Questionnaire
Self reported Disability related with low back pain, the score is 0- 24. It will be applied in the initial evaluation, after of five weeks of intervention and 6 weeks after of second evaluation.
Measured: 5 weeks
Health Related Quality of Life
Questionnaire consist in twelve questions that e assessment difference health domains related with quality of life
Measured: 5 weeks
Secondary outcomes (2)
Posture
Alignment with gravity line. We Will take a photography, it will be analyzed in a ADIBAS software to identificate the alignment of the participant according to the line gravity.
Measured: 5 weeks
Trunk Range of movement
The mobee digital goniometer is used to calculate the flexion and trunk extension angle
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study startFeb 2019 (estimated)
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de la Sabana
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Ramón Llull
- Responsible party
- Sponsor
- Investigators
- Margareth L Alfonso-Mora, Mg, Principal investigator, Universiad de La Sabana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03738306
- Sponsor's protocol ID
- ENF-26-2018
- Status last verified
- Dec 2018
- First submitted
- 8 Nov 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pellecchia MT, Grasso A, Biancardi LG, Squillante M, Bonavita V, Barone P. Physical therapy in Parkinson's disease: an open long-term rehabilitation trial. J Neurol. 2004 May;251(5):595-8. doi: 10.1007/s00415-004-0379-2.
PubMed 15164194Pepe L, Milani R, Di Trani M, Di Folco G, Lanna V, Solano L. A more global approach to musculoskeletal pain: expressive writing as an effective adjunct to physiotherapy. Psychol Health Med. 2014;19(6):687-97. doi: 10.1080/13548506.2013.859712. Epub 2013 Nov 20.
PubMed 24251961Valencia M, Alonso B, Alvarez MJ, Barrientos MJ, Ayan C, Martin Sanchez V. Effects of 2 physiotherapy programs on pain perception, muscular flexibility, and illness impact in women with fibromyalgia: a pilot study. J Manipulative Physiol Ther. 2009 Jan;32(1):84-92. doi: 10.1016/j.jmpt.2008.07.003.
PubMed 19121466Morey M, Bargay J, Galmes A, Besalduch J. [Plasma cell leukemia]. Sangre (Barc). 1989 Jun;34(3):245. No abstract available. Spanish.
PubMed 2762987
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mézières Method for "The Use of Self" in People With Low Back Pain. Mixed Study.
- ClinicalTrials.gov ID
- NCT03738306
- Acronym / sponsor ID
- ENF-26-2018
- Conditions
- Low Back Pain, Mechanical
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidad de la SabanaUniversity, hospital or other
- Collaborators
- Universidad Ramón Llull
- Study start
- Feb 2019 (estimated)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 13 Nov 2018 (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 Mezieres method was born in France with the physiotherapist Francoiçe Mezieres, who in the middle of the previous century began a series of observations that led her to rediscover body characteristics to understand it in a revolutionary way. Among the most important contributions is the first description of muscle chains, from which different global physiotherapy techniques have emerged. The method also proposes a form of intercorporal relationship different from that used in classical physiotherapy and gives way for people who receive this treatment to improve their body disposition and make use of their body in a conscientious manner. From this, in the present study we try to understand this method as one of the ones that promotes the "Use of self". In addition to identifying other aspects related to the meaning of the corporal intersubjectivity for the physiotherapist and for the person being treated, looking for the subjective construction of effectiveness and determining the objective effectiveness by means of objective measurements of the body.
The present research project use a mix method, it aims quantify the bodily benefits when applying the method and understand from the subjectivity the implications for the self during the body activity of the Mezieres Method. The study will be mixed and in parallel with 82 people diagnosed with mechanical back pain. Three assessments will be made: one initial, one at the end of the intervention and one last follow-up six weeks after the end of the treatment. The tests to be used will assess pain, functional limitation related to low back pain, quality of life related to health, flexibility, range of motion and posture. For the intervention, participants will be divided into 2 groups, group one will receive Method Mézières and group two will receive conventional physiotherapy according to the protocols of a clinical institution in Bogotá. Parallel to the intervention, the participating individuals and physiotherapists will keep a field diary that will facilitate the understanding of the body experience by performing the method studied.
At the end of the study, it is intended to know the objective effectiveness by means of the comparison made in the two groups in the variables studied. In addition, an interpretation of the body experience is expected when performing the Mezieres Method in comparison with conventional physiotherapy. This interpretation of hermeneutic character will revolve around the theoretical construction of the "Use of self"; This concept is recognized as a technology of the self that will be pursued through the Mézières Method. By promoting the "Use of self" the person can recognize their body and appropriate what happens with their locomotor system, decreasing the symptoms of pain and improving the prognosis of care for people who have these symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mezieres Method | Experimental | Other: Mezieres MethodThe Mézières treatment has 3 postures that could be adapted to each patient, depending on his/her needs to correct variations in the dorsal curve and promote diaphragmatic breathing. The first objective was to recover extensibility of the hypertonic muscle groups and, in particular, those in the low back muscular chain. The time of tratment will be of 1 hour, two times a week, during 5 weeks. |
| Conventional Physiotherapy | Active comparator | Other: Conventional PhysiotherapyThe treatment with conventional physiotherapy will include stretching of hamstrings, gluteus, (and others) hot pack, transcutaneous electrical nerve stimulation, ultrasound and some exercises of core performance.The time of treatment will be of 1 hour, two times a week, during 5 weeks. |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- People with low back pain (LBP) (mechanical)
- people with LBP of at least three months
- people with LBP with a requirement from medicine to be treated by physiotherapy
- people with Roland Morris Questionnaire major to 4.
Key exclusion criteria (5 listed)
- Anamnesis with red flags related with low back pain
- signs of lumbar pain associated with compression or radicular injury
- shortening of the lower limb or any mechanical modification that affects the lumbopelvic complex.
- post-surgery of the spine
- symptoms of depression or emotional risk factors that worsen the clinical
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 |
|---|---|---|
| Mezieres Method"The Mézières treatment have 3 postures that could be adapted to each patient, depending on his/her needs to correct variations in the dorsal curve and promote diaphragmatic breathing. The first objective was to recover extensibility of the hypertonic muscle groups and, in particular, those in the low back muscular chain: the paravertebral muscles and latissimus dorsi". | Other | Mezieres Method |
| Conventional Physiotherapytherapeutic exercise; physical agents | Other | Conventional Physiotherapy |
Primary outcome
Roland Morris Questionnaire
Time frame: 5 weeks
Self reported Disability related with low back pain, the score is 0- 24. It will be applied in the initial evaluation, after of five weeks of intervention and 6 weeks after of second evaluation.
Health Related Quality of Life
Time frame: 5 weeks
Questionnaire consist in twelve questions that e assessment difference health domains related with quality of life
2 secondary outcomes
Posture
Time frame: 5 weeks
Trunk Range of movement
Time frame: 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Background: PubMed 15164194Pellecchia MT, Grasso A, Biancardi LG, Squillante M, Bonavita V, Barone P. Physical therapy in Parkinson's disease: an open long-term rehabilitation trial. J Neurol. 2004 May;251(5):595-8. doi: 10.1007/s00415-004-0379-2.
- Background: PubMed 24251961Pepe L, Milani R, Di Trani M, Di Folco G, Lanna V, Solano L. A more global approach to musculoskeletal pain: expressive writing as an effective adjunct to physiotherapy. Psychol Health Med. 2014;19(6):687-97. doi: 10.1080/13548506.2013.859712. Epub 2013 Nov 20.
- Background: PubMed 19121466Valencia M, Alonso B, Alvarez MJ, Barrientos MJ, Ayan C, Martin Sanchez V. Effects of 2 physiotherapy programs on pain perception, muscular flexibility, and illness impact in women with fibromyalgia: a pilot study. J Manipulative Physiol Ther. 2009 Jan;32(1):84-92. doi: 10.1016/j.jmpt.2008.07.003.
- Results publication: PubMed 2762987Morey M, Bargay J, Galmes A, Besalduch J. [Plasma cell leukemia]. Sangre (Barc). 1989 Jun;34(3):245. No abstract available. Spanish.
- 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.
Adriana L Castellanos-Garrido, Mg contact
Margareth L Alfonso-Mora, Mg principal investigator
Universiad de La Sabana
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Mezieres Method and Conventional Physiotherapy in people with Low Back Pain, Mechanical, run by Universidad de la Sabana.
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 4 inclusion and 5 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 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Margareth L Alfonso-Mora, Mg (+573142583014, margarethalmo@unisabana.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Roland Morris Questionnaire (time frame: 5 weeks). 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 NCT03738306, which also lists 4 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 19 Dec 2018.