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

Low Back Pain Clinical Trial

— Mc-SubLomb  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03720444
• Other study ID #: RC18_ 0269
• Status: Not yet recruiting
• Start date: January 1, 2019
• Est. completion date: May 1, 2019

Study information

• Verified date: October 2018
• Source: Nantes University Hospital
• Contact: Celine BOUTON, Professor
• Phone: +33(0)244769055
• Email: celine.bouton[@]univ-nantes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• MDT (mechanical diagnosis and therapy) method
The intervention consists of a first session to carry out an assessment, followed by 4 reassessment sessions

Locations

Country	Name	City	State
France	Picasso physiotherapy cabinet (5 rue Nina Simone - 44 000 NANTES)	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

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