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

Low Back Pain Clinical Trial

— TELELOMB  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05390762
• Other study ID #: 2022-A00129-34
• Status: Recruiting
• Phase: N/A
• Start date: May 3, 2022
• Est. completion date: April 2024

Study information

• Verified date: May 2022
• Source: Pôle Saint Hélier
• Contact: Philippe Gallien
• Phone: 02.99.29.50.21
• Email: philippe.gallien[@]pole-sthelier.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Common phase
A common face to face day hospital combining physical therapies with psychotherapeutic support such as Cognitive Behavioral Therapy to combat kinesiophobia.
• Telecare rehabilitation
A Second phase of 5 weeks of telecare rehabilitation of the reconditioning type of 15 sessions.
• Care 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.

Locations

Country	Name	City	State
France	Pôle Saint-Hélier	Rennes	Bretagne

Sponsors (1)

Lead Sponsor	Collaborator
Pôle Saint Hélier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oswestry Disability Index	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.	3 months after the end of rehabilitation
Secondary	Economic efficiency	The 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.	At the end of the rehabilitation
Secondary	Spontaneous pain	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.	At the end of the rehabilitation and 3 month after.
Secondary	Overall flexibility	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.	At the end of the rehabilitation and 3 month after.
Secondary	Range of motion of lumbar mobility	Active range of motion of lumbar flexion and lumbar extension will be measured with two inclinometers. Higher the score is, the better it is.	At the end of the rehabilitation and 3 month after.
Secondary	Sub pelvis muscle flexibility.	The sub pelvis muscle flexibility will be measured by goniometry and centimetry. Higher the score is, the better it is.	At the end of the rehabilitation and 3 month after.
Secondary	Quadriceps strength	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.	At the end of the rehabilitation and 3 month after.
Secondary	Endurance of trunk extensors	Measured by the Sorensen-Biering Test (duration in seconds), higher the score is, the better it is.	At the end of the rehabilitation and 3 month after.
Secondary	Endurance of trunk flexors	Measured by the Shirado test (duration in seconds), higher the score is, the better it is.	At the end of the rehabilitation and 3 month after.
Secondary	Anxiety and depression	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.	At the end of the rehabilitation and 3 month after.
Secondary	The kinesiophobia	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.	At the end of the rehabilitation and 3 month after.
Secondary	Functional abilities	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).	At the end of the rehabilitation and 3 month after.
Secondary	Socio professional criteria	The rate of patients having resumed a professional activity and condition of resumption (part-time therapeutic or not, previous position or adapted position).	3 months after the end of rehabilitation
Secondary	Compliance	Self-assessment compliance evaluated by an adherence booklet	At the end of the rehabilitation
Secondary	Acceptability	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.	At the end of the rehabilitation program and 3 months after.