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

• Conditions: Low Back Pain
• Interventions: Other: MDT (mechanical diagnosis and therapy) method

• Registration Number: NCT03720444
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-10
• Study First Submitted: 2018-10-24
• Study First Submitted QC: 2018-10-24
• Study First Posted: 2018-10-25
• Last Update Submitted: 2018-10-25
• Last Update Posted: 2018-10-29
• Study Start: 2019-01-01
• Primary Completion: 2019-05-01
• Study Completion: 2019-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• 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).

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MDT (mechanical diagnosis and therapy) method	MDT (mechanical diagnosis and therapy) method	-

Primary Outcome Measures

Name	Time	Method
Evolution over time of patients' pain	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Evolution of the pain localization will be done on a body chart filled daily by the patient	3 months	Evolution of the pain localization will be done on a body chart filled daily by the patient
Evolution of drug consumption through a completed questionnaire daily by the patient	3 months	Evolution of drug consumption through a completed questionnaire daily by the patient
Evolution of functional disability through the EIFEL questionnaire	3 months	Evolution of functional disability through the EIFEL questionnaire
Evolution of psychosocial factors by STarT Back	3 months	Evolution of psychosocial factors by STarT Back
Evolution of beliefs and fears through the FABQ (Fear Avoidance Belief) questionnaire	3 months	Evolution of beliefs and fears through the FABQ (Fear Avoidance Belief) questionnaire

Trial Locations

Locations (1)

Picasso physiotherapy cabinet (5 rue Nina Simone - 44 000 NANTES); 🇫🇷 Nantes, France