NCT05261828

Brief Summary

The main purpose of this study is to assess the clinical efficiency of an intervention including a short multidisciplinary program of education and rehabilitation and a personalized follow-up, in patients with subacute and chronic low back pain and no severe disability. The secondary objectives are:

  • to assess the capacity of the program to modify and reduce the risk factors for evolution of patients towards a severe disability,
  • to estimate the cost-utility ratio of the intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

February 9, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
12 months until next milestone

Study Start

First participant enrolled

February 14, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2025

Completed
Last Updated

December 1, 2025

Status Verified

November 1, 2025

Enrollment Period

2 years

First QC Date

February 9, 2022

Last Update Submit

November 24, 2025

Conditions

Non Specific Low Back Pain

Keywords

low back painactivity limitationsdisabilityrehabilitationphysiotherapyexercise

Outcome Measures

Primary Outcomes (1)

  • low back pain activity limitation

    Variation in the level of low back pain- activity limitation assessed by the Roland-Morris self-administered questionnaire (0, no limitation and 24, maximum limitation)

    3 months

Secondary Outcomes (7)

  • low back pain activity limitation

    6 and 12 months.

  • fears and beliefs about work

    3 months

  • fears and beliefs about physical activity

    3 months

  • days off work

    3 and 12 months

  • low back pain

    3 months

  • +2 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL

Short multidisciplinary program including education and rehabilitation and a personalized follow-up program

Behavioral: Education and rehabilitation associated with personalized follow-up

B

ACTIVE COMPARATOR

Reassuring messages and advices in agreement with the current recommendations.

Behavioral: Reassuring messages and advices

Interventions

Education and rehabilitation associated with personalized follow-upBEHAVIORAL

short multidisciplinary program including education and rehabilitation and a personalized follow-up for patients with subacute and chronic low back pain

A
Reassuring messages and advicesBEHAVIORAL

Reassuring messages and advices in agreement with current recommendations

B

Eligibility Criteria

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

You may qualify if:

  • Patients with subacute or chronic nonspecific low back pain (current episode duration ≥ 6 weeks), resistant to outpatient management, and including patients with radiculopathy as long as low back pain is predominant over pain in the lower extremity.
  • Patients manifesting fears and false beliefs and/or dramatization: to be included, the patient will have to answer yes to one of the following two questions:
  • Are you afraid to move?
  • Are you afraid you will never get out of it?
  • Patients eligible for a rehabilitation exercise program
  • informed and written consent to participate

You may not qualify if:

  • Age \< 18 years,
  • Insufficient French language proficiency.
  • Patients who have had lumbar spine surgery within the last 12 months.
  • Pregnancy in progress.
  • No affiliation with a health insurance program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cochin Hospital

Paris, 75014, France

Location

MeSH Terms

Conditions

Low Back PainMotor Activity

Interventions

Educational StatusCounseling

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation CharacteristicsMental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Alexandra ROREN, PhD

    APHP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2022

First Posted

March 2, 2022

Study Start

February 14, 2023

Primary Completion

February 4, 2025

Study Completion

November 10, 2025

Last Updated

December 1, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)