Mézières Method in People With Low Back Pain.

December 14, 2018 updated by: Universidad de la Sabana

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.
"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.
therapeutic exercise; physical agents

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 weeks
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
5 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Margareth L Alfonso-Mora, Mg, Universiad de La Sabana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2019

Primary Completion (Anticipated)

February 1, 2020

Study Completion (Anticipated)

February 1, 2021

Study Registration Dates

First Submitted

November 8, 2018

First Submitted That Met QC Criteria

November 8, 2018

First Posted (Actual)

November 13, 2018

Study Record Updates

Last Update Posted (Actual)

December 19, 2018

Last Update Submitted That Met QC Criteria

December 14, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENF-26-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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