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Telecare Rehabilitation Program in Chronic Low Back Pain with Psychological Retention and Predominant Sociability

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05390762
Acronym
TELELOMB
Enrollment
36
Registered
2022-05-25
Start date
2022-05-03
Completion date
2024-06-20
Last updated
2024-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

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.

Interventions

OTHERCommon phase

A common face to face day hospital combining physical therapies with psychotherapeutic support such as Cognitive Behavioral Therapy to combat kinesiophobia.

OTHERTelecare rehabilitation

A Second phase of 5 weeks of telecare rehabilitation of the reconditioning type of 15 sessions.

OTHERCare in Face to Face

A Second phase of 5 weeks of care in face to face day hospital of the reconditioning type of 15 sessions.

Sponsors

Pôle Saint Hélier
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The evaluations will be performed by blind operators of the program.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Oswestry Disability Index3 months after the end of rehabilitationOverall 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

MeasureTime frameDescription
Spontaneous painAt the end of the rehabilitation and 3 month after.The spontaneous pain measured by Visual Analogic Scale, from 0 to 100. The 0 represents no pain at all and 100 the worth pain imaginable.
Overall flexibilityAt the end of the rehabilitation and 3 month after.Measured finger ground distance in centimeters. The patient is asked to touch the ground with both hands while standing with the knees in extension. The distance between the fingertip and the ground is recorded. Higher the distance is, the better it is.
Range of motion of lumbar mobilityAt the end of the rehabilitation and 3 month after.Active range of motion of lumbar flexion and lumbar extension will be measured with two inclinometers. Higher the score is, the better it is.
Sub pelvis muscle flexibility.At the end of the rehabilitation and 3 month after.The sub pelvis muscle flexibility will be measured by goniometry and centimetry. Higher the score is, the better it is.
Quadriceps strengthAt the end of the rehabilitation and 3 month after.Testing will be done 90 degrees of knee flexion using a wall. The maximum holding time will be determined with a chronometer (in seconds). Higher the score is, the better it is.
Endurance of trunk extensorsAt the end of the rehabilitation and 3 month after.Measured by the Sorensen-Biering Test (duration in seconds), higher the score is, the better it is.
Economic efficiencyAt the end of the rehabilitationThe economic efficiency of personalized rehabilitation at the end of the rehabilitation measured by the cost of transport evaluated according to the functional evolution by Oswestry.
Anxiety and depressionAt the end of the rehabilitation and 3 month after.The Anxiety and depression are assessed by the self administered Hospital Anxiety and Depression scale (HAD). It has 14 items from 0 to 3. 7 questions concern, depression and 7 anxiety. The total for each scale is 21. If the score is less than 7, there in no symptomatology.
The kinesiophobiaAt the end of the rehabilitation and 3 month after.Assessment of the kinesiophobia index by the TAMPA questionnaire. There are 17 questions, from 1 to 4. If the score is high (more than 40 on 68), the kinesiophobia is significant.
Functional abilitiesAt the end of the rehabilitation and 3 month after.Evaluation of the functional disability with the dallas pain questionnaire. It's divided in 4 parts : impact on daily activities, impact on the relation between professional activities and leisure, impact on the relation between anxiety and depression and the impact on sociability. The Dallas questionnaire evaluated the impact of pain from 0 (no impact) to 100% (maximum impact).
Socio professional criteria3 months after the end of rehabilitationThe rate of patients having resumed a professional activity and condition of resumption (part-time therapeutic or not, previous position or adapted position).
ComplianceAt the end of the rehabilitationSelf-assessment compliance evaluated by an adherence booklet
AcceptabilityAt the end of the rehabilitation program and 3 months after.The acceptability will be assessed using a 18-item questionnaire based on the Unified Theory of Acceptance and Use of Technology (UTAUT) model. Each questions are based on a Likert-type 5 point scale ranging from : 1=In total disagreement, 2= Somewhat disagree, 3= Neither agree nor disagree, 4= Somewhat agree, 5=In total agreement.
Endurance of trunk flexorsAt the end of the rehabilitation and 3 month after.Measured by the Shirado test (duration in seconds), higher the score is, the better it is.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026