Feasibility of a One-day-and-a-half for Patients With Low Back Pain (LC-ONE)

October 18, 2019 updated by: Assistance Publique - Hôpitaux de Paris

Feasibility of a One-day-and-a-half Multidisciplinary Education and Exercise Therapy Program for Patients With Low Back Pain: a 3-month Retrospective Open Pilot Study

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.

Study Overview

Detailed Description

Retrospectively, data of patients between 18 and 60 years who had benefited in the PMR unit of Cochin' hospital of a one-day-and-a-half no intensive multidisciplinary education and exercise therapy program are collected.

This no intensive multidisciplinary education and exercise therapy program is proposed by the PMR unit of Cochin' hospital to all patients with a subacute or chronic low back pain for whom first-line treatments had failed but for whom an intensive multidisciplinary rehabilitation program is not indicated.

It is done in group of 4 to 6 people, performed by medical doctors with experience in the management of patients with low back pain, physiotherapists, occupational therapists, and psychologist.

Data regarding feasibility of this program were recorded with autoquestionnaires that patients had to fill in during the program and 3 months after.

Study Type

Observational

Enrollment (Actual)

23

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Paris, France, 75014
        • Hôpital Cochin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability
Time Frame: 3 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficiency
Time Frame: 3 months
Efficiency of the program to diminish pain (evaluated by a visual analog scale (VAS) between 0 and 100 with 100 representing the most important pain and 0 no pain at all)
3 months
Efficiency
Time Frame: 3 months
Efficiency of the program to diminish fear and beliefs (FABQ, between 0 and 66 with 66 representing the highest level of fear and beliefs about low back pain and 0 representing no fear and beliefs about low back pain)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Christelle NGUYEN, MD, PhD, APHP (Assistance Publique-Hôpitaux de Paris)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2017

Primary Completion (ACTUAL)

April 1, 2018

Study Completion (ACTUAL)

September 30, 2019

Study Registration Dates

First Submitted

March 21, 2019

First Submitted That Met QC Criteria

October 18, 2019

First Posted (ACTUAL)

October 21, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 21, 2019

Last Update Submitted That Met QC Criteria

October 18, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LC-ONE
  • APHP190887 (OTHER: APHP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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