NCT05390762

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started May 2022

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2024

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

2.1 years

First QC Date

May 6, 2022

Last Update Submit

December 20, 2024

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (14)

  • Economic efficiency

    At the end of the rehabilitation

  • Spontaneous pain

    At the end of the rehabilitation and 3 month after.

  • Overall flexibility

    At the end of the rehabilitation and 3 month after.

  • Range of motion of lumbar mobility

    At the end of the rehabilitation and 3 month after.

  • Sub pelvis muscle flexibility.

    At the end of the rehabilitation and 3 month after.

  • +9 more secondary outcomes

Study Arms (2)

Conventional care in a day hospital

ACTIVE COMPARATOR

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 phaseOther: Care in Face to Face

Telecare rehabilitation

EXPERIMENTAL

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 phaseOther: Telecare rehabilitation

Interventions

Common phaseOTHER

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

Conventional care in a day hospitalTelecare rehabilitation
Telecare rehabilitationOTHER

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

Telecare rehabilitation
Care in Face to FaceOTHER

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

Conventional care in a day hospital

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pôle Saint-Hélier

Rennes, Brittany Region, 35043, France

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jephté Houedakor

    Pôle Saint Hélier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The evaluations will be performed by blind operators of the program.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2022

First Posted

May 25, 2022

Study Start

May 3, 2022

Primary Completion

June 20, 2024

Study Completion

June 20, 2024

Last Updated

December 27, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)