"Evaluation of the Effectiveness of the MDT Method (Mecha... | NCT03720444

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Estimated

Primary Completion Date

May 1, 2019Estimated

Completion Date

May 1, 2019Estimated

First Submitted Date

Oct 24, 2018

First Submission Date that Met QC Criteria

Oct 24, 2018

First Posted Date

Oct 25, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2018

Last Update Posted Date

Oct 29, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MDT (mechanical diagnosis and therapy) method			Other: MDT (mechanical diagnosis and therapy) method

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
Evolution of drug consumption through a completed questionnaire daily by the patient

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

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.

Sampling Method

Non-Probability Sample

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D013812	Therapeutics
D008722	Methods