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Mézières Method in People With Low Back Pain.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03738306
Recruitment Status : Not yet recruiting
First Posted : November 13, 2018
Last Update Posted : December 19, 2018
Sponsor:
Collaborator:
Universidad Ramón Llull
Information provided by (Responsible Party):
Universidad de la Sabana

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Low Back Pain, Mechanical Other: Mezieres Method Other: Conventional Physiotherapy Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mézières Method for "The Use of Self" in People With Low Back Pain. Mixed Study.
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mezieres Method
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.
Other: 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".

Active Comparator: Conventional Physiotherapy
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.
Other: Conventional Physiotherapy
therapeutic exercise; physical agents




Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. Posture [ Time Frame: 5 weeks ]
    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.

  2. Trunk Range of movement [ Time Frame: 5 weeks ]
    The mobee digital goniometer is used to calculate the flexion and trunk extension angle



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Ages Eligible for Study:   19 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03738306


Contacts
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Contact: Margareth L Alfonso-Mora, Mg +573142583014 margarethalmo@unisabana.edu.co
Contact: Adriana L Castellanos-Garrido, Mg adriana.castellanos@unisabana.edu.co

Sponsors and Collaborators
Universidad de la Sabana
Universidad Ramón Llull
Investigators
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Principal Investigator: Margareth L Alfonso-Mora, Mg Universiad de La Sabana

Publications of Results:
Other Publications:
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Responsible Party: Universidad de la Sabana
ClinicalTrials.gov Identifier: NCT03738306    
Other Study ID Numbers: ENF-26-2018
First Posted: November 13, 2018    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms