NCT04133818

Brief Summary

The purpose of this study was to assess the feasibility of a one-day-and-a-half no intensive multidisciplinary education and exercise therapy program in the subgroup of patients with subacute or chronic LBP for whom first-line treatments had failed but for whom an intensive multidisciplinary rehabilitation program was not indicated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2017

Typical duration for all trials

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

July 1, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 21, 2019

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

9 months

First QC Date

March 21, 2019

Last Update Submit

September 5, 2025

Conditions

Keywords

Multidisciplinary education and exercise therapy program.Physical activityRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Acceptability

    Acceptability of the program by the patients (evaluated by a visual analog scale (VAS) between 0 and 100 with 100 representing the best acceptability and 0 the lowest acceptability)

    3 months

Secondary Outcomes (2)

  • Efficiency

    3 months

  • Efficiency

    3 months

Study Arms (1)

Multidisciplinary program.

Patients with subacute or chronic LBP for whom first-line treatments had failed but for whom an intensive multidisciplinary rehabilitation program was not indicated.

Behavioral: Multidisciplinary education and exercise therapy program

Interventions

Multidisciplinary program: one and a half day of education and exercise therapy about low back pain : * Lectures and explanations about low back pain * Physical activity * Relaxation

Multidisciplinary program.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with subacute or chronic LBP for whom first-line treatments had failed but for whom an intensive multidisciplinary rehabilitation program was not indicated and who had benefited in PMR unit of Cochin' hospital of a no intensive multidisciplinary rehabilitation program.

You may qualify if:

  • age ≥ 18 years
  • subacute or chronic non-specific LBP ≥ 6 weeks
  • no indication for an intensive multidisciplinary rehabilitation program according to the senior physician, a specialist in physical medicine and rehabilitation and/or rheumatology with a strong experience in the care of patients with non-specific LBP
  • currently working
  • written consent

You may not qualify if:

  • inability to speak or read French
  • cognitive impairment
  • current sick leave
  • history of intensive multidisciplinary rehabilitation program for LBP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Cochin

Paris, France, 75014, France

Location

Related Publications (4)

  • Freburger JK, Holmes GM, Agans RP, Jackman AM, Darter JD, Wallace AS, Castel LD, Kalsbeek WD, Carey TS. The rising prevalence of chronic low back pain. Arch Intern Med. 2009 Feb 9;169(3):251-8. doi: 10.1001/archinternmed.2008.543.

    PMID: 19204216BACKGROUND
  • Adnan R, Van Oosterwijck J, Cagnie B, Dhondt E, Schouppe S, Van Akeleyen J, Logghe T, Danneels L. Determining Predictive Outcome Factors for a Multimodal Treatment Program in Low Back Pain Patients: A Retrospective Cohort Study. J Manipulative Physiol Ther. 2017 Nov-Dec;40(9):659-667. doi: 10.1016/j.jmpt.2017.09.001.

    PMID: 29229056BACKGROUND
  • Brox JI, Storheim K, Grotle M, Tveito TH, Indahl A, Eriksen HR. Systematic review of back schools, brief education, and fear-avoidance training for chronic low back pain. Spine J. 2008 Nov-Dec;8(6):948-58. doi: 10.1016/j.spinee.2007.07.389. Epub 2007 Nov 19.

    PMID: 18024224BACKGROUND
  • Garofoli R, Boisson M, Segretin F, Linieres J, Gerard C, Moreau S, Ieong E, Chagny F, Bedin C, Lefevre-Colau MM, Rannou F, Roren A, Nguyen C. Feasibility of a short multidisciplinary education and exercise therapy program for patients with non-specific low back pain: A 3-month retrospective open pilot study. Ann Phys Rehabil Med. 2019 Sep;62(5):382-385. doi: 10.1016/j.rehab.2019.05.005. Epub 2019 May 31. No abstract available.

    PMID: 31158552BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Christelle NGUYEN, MD, PhD

    APHP (Assistance Publique-Hôpitaux de Paris)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2019

First Posted

October 21, 2019

Study Start

July 1, 2017

Primary Completion

April 1, 2018

Study Completion

September 30, 2019

Last Updated

September 12, 2025

Record last verified: 2025-09

Locations