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

December 20, 2024 updated by: Pôle Saint Hélier

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
    • Bretagne
      • Rennes, Bretagne, France, 35043
        • Pôle Saint-Hélier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Conventional care in a day hospital
  1. A common face to face day hospital, combining physical therapies with psychotherapeutic support such as Cognitive Behavioral Therapy to combat kinesiophobia.
  2. A Second phase of 5 weeks of care face to face day hospital of the reconditioning type of 15 sessions.
Other: Common phase
A common face to face day hospital combining physical therapies with psychotherapeutic support such as Cognitive Behavioral Therapy to combat kinesiophobia.
Other: 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.
Experimental: Telecare rehabilitation
  1. A common face to face day hospital, combining physical therapies with psychotherapeutic support such as Cognitive Behavioral Therapy to combat kinesiophobia.
  2. A Second phase of 5 weeks of Telecare rehabilitation of the reconditioning type of 15 sessions.
Other: Common phase
A common face to face day hospital combining physical therapies with psychotherapeutic support such as Cognitive Behavioral Therapy to combat kinesiophobia.
Other: Telecare rehabilitation
A Second phase of 5 weeks of telecare rehabilitation of the reconditioning type of 15 sessions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 months after the end of rehabilitation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Economic efficiency
Time Frame: At the end of the rehabilitation
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
Spontaneous pain
Time Frame: At 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.
At the end of the rehabilitation and 3 month after.
Overall flexibility
Time Frame: At 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.
At the end of the rehabilitation and 3 month after.
Range of motion of lumbar mobility
Time Frame: At 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.
At the end of the rehabilitation and 3 month after.
Sub pelvis muscle flexibility.
Time Frame: 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.
At the end of the rehabilitation and 3 month after.
Quadriceps strength
Time Frame: At 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.
At the end of the rehabilitation and 3 month after.
Endurance of trunk extensors
Time Frame: At 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.
At the end of the rehabilitation and 3 month after.
Endurance of trunk flexors
Time Frame: At 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.
At the end of the rehabilitation and 3 month after.
Anxiety and depression
Time Frame: At 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.
At the end of the rehabilitation and 3 month after.
The kinesiophobia
Time Frame: At 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.
At the end of the rehabilitation and 3 month after.
Functional abilities
Time Frame: At 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).
At the end of the rehabilitation and 3 month after.
Socio professional criteria
Time Frame: 3 months after the end of rehabilitation
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
Compliance
Time Frame: At the end of the rehabilitation
Self-assessment compliance evaluated by an adherence booklet
At the end of the rehabilitation
Acceptability
Time Frame: At 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.
At the end of the rehabilitation program and 3 months after.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pôle Saint Hélier

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jephté Houedakor, Pole Saint Helier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 3, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 20, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 6, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 25, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-A00129-34

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings