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Completed

NCT Number: NCT05390762

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

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pôle Saint-Hélier

Rennes, Brittany Region, 35043, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Common phase

Other

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

Telecare rehabilitation

Other

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

Care in Face to Face

Other

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

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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).

  12. 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).

  13. Compliance

    Time frame: At the end of the rehabilitation

    Self-assessment compliance evaluated by an adherence booklet

  14. 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.

Sponsors and collaborators

Lead sponsor

Pôle Saint Hélier

Other

Registry information

Official study 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

Acronym: TELELOMB

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 25, 2022
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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