Motivational Support Program in Chronic Low Back Pain After Multidisciplinary Functional Rehabilitation

NCT05780021 | Recruiting

• 2 other identifiers: APHP2100772022-A00828-35
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic low back pain (CLBP) is a major public health problem. Multidisciplinary functional rehabilitation program (FRP), which give patients the skills to better manage pain and return to physical activity, are effective in the short term. In the medium and long term, due to lack of motivation, two thirds of patients stop their physical activity again, causing them to fall back into the vicious circle of pain. Investigators hypothesise that a remote assessment and motivational support program (MSP) based on an application, piloted by a care coordinator, could allow the continued improvement of symptoms and activities observed after the FRP programs, and thus limit the consequences of CLBP for the patient and society. The main objective of this study is to evaluate the effect of the motivational support program EMOTIV, on disability and pain at one year, in chronic low back pain patients who have benefited from a FRP program.

Conditions

Chronic Low-back Pain

Keywords

Chronic Low-back Pain; Multidisciplinary function rehabilitation; Motivational Support Program Emotiv

Outcome Measures

Primary Outcomes (1)

• Difference in disability and pain between the experimental (SHP) and control (usual care) groups, measured with the Core Outcome Measure Index (COMI) scale at 12 months.

  The Core Outcome Measure Index (COMI) was developed from requirements of international back pain experts. According to European experts, the COMI should currently be recommended in assessment of chronic low back pain. This questionnaire assesses pain and disability in low back pain. It includes 9 items and its score is between 0 and 10. Higher scores is the worse outcome.

  12 months after completion of the multidisciplinary functional rehabilitation program

Secondary Outcomes (21)

• Evolution of pain

  At 3 months, 12 months and 24 months

• Evolution of flexibility

  At 3 months, 12 months and 24 months

• Evolution of muscular endurance

  At 3 months, 12 months and 24 months

• Evolution of muscular endurance

  At 3 months, 12 months and 24 months

• Evolution of disability and pain

  At 3 months, 12 months and 24 months

Study Arms (2)

Standard arm

NO INTERVENTION

The patients will have the usual care

Motivational Support Program Emotiv

EXPERIMENTAL

The patients will have the motivational support program

Behavioral: Motivational Support Program Emotiv

Interventions

Motivational Support Program Emotiv BEHAVIORAL

A motivational support program including a motivational and self-assessment remote application in the form of a Smartphone application for chronic low back pain patients after multidisciplinary functional rehabilitation.

Motivational Support Program Emotiv

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 or over
• Disabling chronic low back pain: chronic painful patient, that is to say suffering from pain for more than 3 months, having interrupted all physical activity because of low back pain and have an indication for a FRP for low back pain.
• Having reached the end of an FRP program
• Possession of a smartphone
• Fluency in French (writing, reading)
• Health insurance coverage (beneficiary or beneficiary) except State Medical Aid.
• Patient Informed Consent Signature

You may not qualify if:

• Pregnant woman
• Patient refusal
• Patient deprived of liberty and patient under legal protection measure (guardianship, guardianship)
• Patient participating to another interventional search

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Pitié Salpêtrière

Paris, 75013, France

RECRUITING

Study Officials

• Violaine FOLTZ, Dr

  Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Violaine FOLTZ, Dr

CONTACT

01 42 17 79 58; violaine.foltz@aphp.fr

Bruno FAUTREL, Pr

CONTACT

01 42 17 78 01; bruno.fautrel@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: March 22, 2023
• Study Start: September 26, 2023
• Primary Completion: September 26, 2025
• Study Completion (Estimated): September 26, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

FR (1)