NCT00960583

Brief Summary

The purpose of the study is to compare, after functional multidisciplinary rehabilitation for chronic low back pain, an exercise program to the routine follow-up which is simply to advice patients to exercise regularly at home. The exercise program should help patients stay active, which should translate into a better long term quality of life and decreased days off work.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 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

Study Start

First participant enrolled

January 1, 2005

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2009

Completed
Last Updated

May 11, 2016

Status Verified

May 1, 2016

Enrollment Period

3.8 years

First QC Date

August 17, 2009

Last Update Submit

May 10, 2016

Conditions

Keywords

Chronic low back painMultidisciplinary rehabilitationExerciseCost-effectiveness

Outcome Measures

Primary Outcomes (2)

  • Quality of life

    End of functional multidisciplinary rehabilitation, 1 year follow-up

  • Direct and indirect costs

    Before functional multidisciplinary rehabilitation, 1 year follow-up

Study Arms (2)

Exercise program

EXPERIMENTAL

Exercise program comprising muscle strengthening, cardiovascular training and stretching exercises. Program duration : 12 weeks Sessions frequency : twice per week Session duration : 1h30

Other: Exercise program

Routine follow-up

ACTIVE COMPARATOR

Routine follow-up after functional multidisciplinary rehabilitation by attending physician (Advice to stay active)

Other: Routine follow-up

Interventions

24 group exercise sessions during 12 weeks

Exercise program

Advice to stay active

Routine follow-up

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • subacute or chronic low back pain
  • phases 2 to 6 of the Krause classification
  • without irritative neurological deficit
  • age between 18 and 60
  • having completed functional multidisciplinary rehabilitation

You may not qualify if:

  • phases 7 and 8 of the Krause classification
  • entitled to a total disability pension
  • acute neurological deficit in progress
  • sciatica
  • pregnancy
  • acute inflammatory rheumatic disease
  • non-osteoarticular thoracic pain
  • spinal fracture within the last 3 months
  • osteoporosis
  • tumor
  • severe heart failure or respiratory failure
  • active drug addiction
  • current involvement in litigation related to low back pain
  • active psychiatric pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université de Lausanne, Service de Rhumatologie, Département de l'Appareil Locomoteur

Lausanne, Switzerland

Location

Related Publications (2)

  • Henchoz Y, de Goumoens P, Norberg M, Paillex R, So AK. Role of physical exercise in low back pain rehabilitation: a randomized controlled trial of a three-month exercise program in patients who have completed multidisciplinary rehabilitation. Spine (Phila Pa 1976). 2010 May 20;35(12):1192-9. doi: 10.1097/BRS.0b013e3181bf1de9.

  • Henchoz Y, Pinget C, Wasserfallen JB, Paillex R, de Goumoens P, Norberg M, Kai-Lik So A. Cost-utility analysis of a three-month exercise programme vs usual care following multidisciplinary rehabilitation for chronic low back pain. J Rehabil Med. 2010 Oct;42(9):846-52. doi: 10.2340/16501977-0610.

MeSH Terms

Conditions

Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Alexander KL So, PhD, FRCP

    Université de Lausanne, Service de Rhumatologie, Département de l'Appareil Locomoteur, Lausanne, Suisse

    STUDY DIRECTOR
  • Pierre de Goumoëns, MD

    Université de Lausanne, Service de Rhumatologie, Département de l'Appareil Locomoteur, Lausanne, Suisse

    STUDY CHAIR
  • Michael Norberg, MD

    Université de Lausanne, Service de Rhumatologie, Département de l'Appareil Locomoteur, Lausanne, Suisse

    STUDY CHAIR
  • Roland Paillex, PT, MS

    Centre Hospitalier Universitaire Vaudois (CHUV), Direction des soins, Lausanne, Suisse

    STUDY CHAIR
  • Christophe Pinget, PhD

    Institute of Health Economics and Management, University of Lausanne and Health Technology Assessment Unit, Medical Direction, University Hospital of Lausanne (CHUV)

    STUDY CHAIR
  • Jean-Blaise Wasserfallen, MD, MPP

    Institute of Health Economics and Management, University of Lausanne and Health Technology Assessment Unit, Medical Direction, University Hospital of Lausanne (CHUV)

    STUDY CHAIR
  • Yves Henchoz, MS

    Université de Lausanne, Institut des sciences du sport et de l'éducation physique, Lausanne, Suisse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

August 17, 2009

First Posted

August 18, 2009

Study Start

January 1, 2005

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

May 11, 2016

Record last verified: 2016-05

Locations