NCT02564185

Brief Summary

According to the WHO, therapeutic education is intended to help patients acquire or maintain the skills they need to optimally manage living with a chronic disease. Low back pain is frequent and therapeutic education could be a promising option. The purpose of the study is to evaluate the impact of a therapeutic education program for patients suffering from low back pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Sep 2010

Longer than P75 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

September 1, 2010

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2015

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

5.1 years

First QC Date

September 29, 2015

Last Update Submit

January 31, 2017

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (2)

  • Quality of life

    EIFEL functional disability scale (Gagnon et al, Annals Phys Med Rehab, 2009, 1, 3-16).

    6 months

  • Quality of life

    DRAD questionnaire (Lawlis et al, Spine 1989;14:511-6.)

    6 months

Secondary Outcomes (4)

  • Pain

    6 months

  • Neuropathic pain

    6 months

  • Social impact

    6 months

  • Evaluation of the program

    6 months

Study Arms (2)

Control

ACTIVE COMPARATOR

The "control" group will follow usual practice.

Other: Usual practice

Education program

EXPERIMENTAL

The "Education program" group benefit in addition of a therapeutic education program including nursing follow-up at 1, 3 and 6 months.

Other: Usual practiceOther: Education program

Interventions

Usual practiceOTHER
ControlEducation program
Education programOTHER
Education program

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Low back pain
  • Treatment with transcutaneous electrical nerve stimulation (TENS)

You may not qualify if:

  • Contra-indication of TENS
  • Patients with mental disorders
  • Lack of autonomy or patients living alone at home without help

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Foch

Suresnes, 92150, France

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

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

September 29, 2015

First Posted

September 30, 2015

Study Start

September 1, 2010

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

February 1, 2017

Record last verified: 2017-01

Locations

FR(1)