"Evaluation of the Effectiveness of the MDT Method (Mechanical Diagnosis and Therapy) in the Management of Low Back Pain in the Subacute Phase"

NCT03720444 | Unknown DMC

• 1 other identifier: RC18_ 0269
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators propose to carry out a study evaluating the effectiveness of the MDT method (mechanical diagnosis and therapy) in the subacute phase of common low back pain. Few studies have specifically evaluated the effectiveness of the MDT method in the subacute phase, a phase that appears to be crucial before the chronicization of low back pain. The main objective of this study will be to evaluate the pain of patients managed by the MDT method. The analysis of the main criterion (Visual Analog Scale) will be done using a type individual clinical trial specific: the Single Case Experimental Design or SCED in lines of multiple bases. This type of study makes it possible to carry out a comparative test on a single subject acting as its own witness in order to obtain an acceptable level of evidence response for that particular patient.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Evolution over time of patients' pain

  The main outcome will be the evolution over time of patients' pain as assessed by a visual analogue scale completed daily by the patient himself.

  3 months

Secondary Outcomes (5)

• Evolution of the pain localization will be done on a body chart filled daily by the patient

  3 months

• Evolution of drug consumption through a completed questionnaire daily by the patient

  3 months

• Evolution of functional disability through the EIFEL questionnaire

  3 months

• Evolution of beliefs and fears through the FABQ (Fear Avoidance Belief) questionnaire

  3 months

• Evolution of psychosocial factors by STarT Back

  3 months

Study Arms (1)

MDT (mechanical diagnosis and therapy) method

Other: MDT (mechanical diagnosis and therapy) method

Interventions

MDT (mechanical diagnosis and therapy) method OTHER

The intervention consists of a first session to carry out an assessment, followed by 4 reassessment sessions

MDT (mechanical diagnosis and therapy) method

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population is all patients aged 18 to 55 years who consult with one of the Mc Kenzie physiotherapists participating in the study, for a common low back pain reason between 4 and 12 weeks of evolution. The first ten patients consulting one of the physiotherapists involved and meeting the criteria will be recruited. Each patient will receive information about the research and sign a consent. Patients with a strong suspicion of specific low back pain will be excluded from the outset.

You may qualify if:

• Consultant patients at the Picasso physiotherapy practice (5 rue Nina Simone - 44 000 NANTES)
• Aged 18 to 55 years old
• Suffering from common-looking low back pain. Low back pain is defined as pain or localized discomfort under the 12th dorsal vertebrae and above the inner fold buttock, with possible irradiation to the lower limb but not exceeding the knee.
• Evolving for 4 to 12 weeks (subacute period).
• Period preceded by a period of 30 days without low back pain (in order to avoid recurrent low back pain, rather similar to the chronic phase).

You may not qualify if:

• Signs of specific low back pain (confirmed or highly suspected diagnosis): fracture, infection, osteoporosis, inflammatory disease, tumor
• Irradiation below the knee
• Patient knowing she is pregnant
• Protected adults
• Patient with proven cognitive impairment
• Patient with a decompensated psychiatric pathology
• Incapacity to consent
• Refusal to participate in the study

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Picasso physiotherapy cabinet (5 rue Nina Simone - 44 000 NANTES)

Nantes, 44000, France

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Therapeutics; Methods

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Celine BOUTON, Professor

  Nantes University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Celine BOUTON, Professor

CONTACT

+33(0)244769055; celine.bouton@univ-nantes.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: October 25, 2018
• Study Start: January 1, 2019
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: October 29, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)