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Mézières Method in People With Low Back Pain.

Primary Purpose

Low Back Pain, Mechanical

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Mezieres Method
Conventional Physiotherapy
Sponsored by
Universidad de la Sabana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain, Mechanical

Eligibility Criteria

19 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Mezieres Method

    Conventional Physiotherapy

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    Health Related Quality of Life
    Questionnaire consist in twelve questions that e assessment difference health domains related with quality of life

    Secondary Outcome Measures

    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.
    Trunk Range of movement
    The mobee digital goniometer is used to calculate the flexion and trunk extension angle

    Full Information

    First Posted
    November 8, 2018
    Last Updated
    December 14, 2018
    Sponsor
    Universidad de la Sabana
    Collaborators
    Universidad Ramón Llull
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03738306
    Brief Title
    Mézières Method in People With Low Back Pain.
    Official Title
    Mézières Method for "The Use of Self" in People With Low Back Pain. Mixed Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2019 (Anticipated)
    Primary Completion Date
    February 2020 (Anticipated)
    Study Completion Date
    February 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Universidad de la Sabana
    Collaborators
    Universidad Ramón Llull

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Back Pain, Mechanical

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Mezieres Method
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Conventional Physiotherapy
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Mezieres Method
    Intervention Description
    "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".
    Intervention Type
    Other
    Intervention Name(s)
    Conventional Physiotherapy
    Intervention Description
    therapeutic exercise; physical agents
    Primary Outcome Measure Information:
    Title
    Roland Morris Questionnaire
    Description
    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.
    Time Frame
    5 weeks
    Title
    Health Related Quality of Life
    Description
    Questionnaire consist in twelve questions that e assessment difference health domains related with quality of life
    Time Frame
    5 weeks
    Secondary Outcome Measure Information:
    Title
    Posture
    Description
    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.
    Time Frame
    5 weeks
    Title
    Trunk Range of movement
    Description
    The mobee digital goniometer is used to calculate the flexion and trunk extension angle
    Time Frame
    5 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Margareth L Alfonso-Mora, Mg
    Phone
    +573142583014
    Email
    margarethalmo@unisabana.edu.co
    First Name & Middle Initial & Last Name or Official Title & Degree
    Adriana L Castellanos-Garrido, Mg
    Email
    adriana.castellanos@unisabana.edu.co
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Margareth L Alfonso-Mora, Mg
    Organizational Affiliation
    Universiad de La Sabana
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    15164194
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24251961
    Citation
    Pepe 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.
    Results Reference
    background
    PubMed Identifier
    19121466
    Citation
    Valencia 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 Reference
    background
    PubMed Identifier
    2762987
    Citation
    Morey M, Bargay J, Galmes A, Besalduch J. [Plasma cell leukemia]. Sangre (Barc). 1989 Jun;34(3):245. No abstract available. Spanish.
    Results Reference
    result

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    Mézières Method in People With Low Back Pain.

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