Evaluation of the Functional Efficacy of a Multidisciplinary Telecare Rehabilitation Program in Chronic Low Back Pain with Psychological Retention and Predominant Sociability : Single Center Randomized Controlled, Single-blind Trial

Pôle Saint Hélier1 site in 1 country36 target enrollmentMay 3, 2022

ConditionsLow Back Pain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Low Back Pain
Sponsor: Pôle Saint Hélier
Enrollment: 36
Locations: 1
Primary Endpoint: Oswestry Disability Index
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The present study proposes to evaluate the impact of a multidisciplinary biopsychosocial Telecare rehabilitation program at the functional level in people with chronic low back pain with major psycho-behavior maintenance. The hypothesis is that a personalized program combining remote psycho-professional and physical care by digital tools improves functional evaluation in these patients.

Registry

clinicaltrials.gov

Start Date

May 3, 2022

End Date

June 20, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pôle Saint Hélier

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Chronic low back pain (evolution of more than 3 months)
•Patient treated for this pathology in a multidisciplinary program
•Dallas score \> 50% in anxiety/depression and sociability dimensions
•Patient who has given free and informed consent to participate in the research
•Patient affiliated to a social security scheme or beneficiary of such a scheme.
•Patient with an internet connection at home, allowing videoconferencing and a digital tool with web cam (tablet or computer).

Exclusion Criteria

•Recent spine surgery (\< 3 months at inclusion visit)
•Cardiovascular risk factor contraindicating sports practice.
•Severe psychiatric pathology
•Low back pain of tumoral or inflammatory origin.
•Associated motor or sensory, neurological impairment.
•Disabling root irradiation
•Pregnant or breastfeeding women
•Patients under legal protection (guardianship, curators or safeguard of justice).

Outcomes

Primary Outcomes

Oswestry Disability Index

Time Frame: 3 months after the end of rehabilitation

Overall score of the Oswestry self-questionnaire. The score goes from 0 to 50, It will be converted into a percentage (Score ODI). Zero is equated with no disability and 100 is the maximum disability possible.

Secondary Outcomes

Sub pelvis muscle flexibility.(At the end of the rehabilitation and 3 month after.)
Spontaneous pain(At the end of the rehabilitation and 3 month after.)
Endurance of trunk extensors(At the end of the rehabilitation and 3 month after.)
Endurance of trunk flexors(At the end of the rehabilitation and 3 month after.)
Range of motion of lumbar mobility(At the end of the rehabilitation and 3 month after.)
Overall flexibility(At the end of the rehabilitation and 3 month after.)
Economic efficiency(At the end of the rehabilitation)
Compliance(At the end of the rehabilitation)
Quadriceps strength(At the end of the rehabilitation and 3 month after.)
Anxiety and depression(At the end of the rehabilitation and 3 month after.)
Socio professional criteria(3 months after the end of rehabilitation)
The kinesiophobia(At the end of the rehabilitation and 3 month after.)
Functional abilities(At the end of the rehabilitation and 3 month after.)
Acceptability(At the end of the rehabilitation program and 3 months after.)