Clinical trial NCT05390762: Telecare Rehabilitation Program in Chronic Low Back Pain with Psychological Retention and Predominant Sociability
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Pôle Saint Hélier
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Oswestry Disability Index
timeFrame: 3 months after the end of rehabilitation
Secondary outcomes:
measure: Economic efficiency
timeFrame: At the end of the rehabilitation
measure: Spontaneous pain
timeFrame: At the end of the rehabilitation and 3 month after.
measure: Overall flexibility
timeFrame: At the end of the rehabilitation and 3 month after.
measure: Range of motion of lumbar mobility
timeFrame: At the end of the rehabilitation and 3 month after.
measure: Sub pelvis muscle flexibility.
timeFrame: At the end of the rehabilitation and 3 month after.
measure: Quadriceps strength
timeFrame: At the end of the rehabilitation and 3 month after.
measure: Endurance of trunk extensors
timeFrame: At the end of the rehabilitation and 3 month after.
measure: Endurance of trunk flexors
timeFrame: At the end of the rehabilitation and 3 month after.
measure: Anxiety and depression
timeFrame: At the end of the rehabilitation and 3 month after.
measure: The kinesiophobia
timeFrame: At the end of the rehabilitation and 3 month after.
measure: Functional abilities
timeFrame: At the end of the rehabilitation and 3 month after.
measure: Socio professional criteria
timeFrame: 3 months after the end of rehabilitation
measure: Compliance
timeFrame: At the end of the rehabilitation
measure: Acceptability
timeFrame: At the end of the rehabilitation program and 3 months after.
Other outcomes:
Locations:
city: Rennes
country: France
facility: Pôle Saint-Hélier
state: Bretagne
Study officials:
affiliation: Pôle Saint Hélier
name: Jephté Houedakor
role: PRINCIPAL_INVESTIGATOR
References: