NCT02466360

Brief Summary

Non-specific chronic lower back pain is a common pathology which is a real public health problem. Around 84% of the population could have non-specific chronic lower back pain at least once in their lives and 8% of that non-specific lower back pain could become chronical (pain that would last at least 3 months). This proportion of patients represents 85% of the costs related to this pathology. Physical activity practice is involved in medical care for plenty of chronical diseases and particularly for chronic lower back pain. In 2003, World Health Organization pointed out the poor adhesion of patients with chronical diseases to medical prescriptions and the after-effects it could have on illness evolution. Therefore, adhesion to physical activity practice for patients with chronic lower back pain is one of the most challenging matters for medical teams. The aim of this study was to identify the brakes and levers of physical activity practice for these patients. Sixteen individual interviews and four focus groups have been carried out on patients with chronic lower back pain who were taken care of either by a rachis functional restoration program or by primary care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2012

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

January 1, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 9, 2015

Completed
Last Updated

June 9, 2015

Status Verified

June 1, 2015

Enrollment Period

2.2 years

First QC Date

June 5, 2015

Last Update Submit

June 8, 2015

Conditions

Non-specific Chronic Lower Back Pain

Keywords

Non-specific chronic lower back painPhysical activitySelf-exercisesBrakesLeversAdhesionSelf-care

Outcome Measures

Primary Outcomes (1)

  • Individual interviews

    patients with non-specific chronic lower back pain explain directly to their doctors what is preventing them from having physical activity

    at day 1

Secondary Outcomes (5)

  • questions about their lower back pain and physical activity

    at day 1

  • Back Belief questionnaire

    at day 1

  • QUEBEC scale

    at day 1

  • Fear Avoidance Beliefs questionnaire

    at day 1

  • Visual Analog Scale

    at day 1

Study Arms (1)

chronic lower back pain

Behavioral: Back Belief questionnaireBehavioral: QUEBEC scaleBehavioral: Fear Avoidance beliefs questionnaireBehavioral: Visual analog scaleBehavioral: individual interviewsBehavioral: Focus groups

Interventions

Back Belief questionnaireBEHAVIORAL
chronic lower back pain
QUEBEC scaleBEHAVIORAL
chronic lower back pain
Fear Avoidance beliefs questionnaireBEHAVIORAL
chronic lower back pain
Visual analog scaleBEHAVIORAL
chronic lower back pain
individual interviewsBEHAVIORAL
chronic lower back pain
Focus groupsBEHAVIORAL
chronic lower back pain

Eligibility Criteria

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

patients with chronic lower back pain

You may qualify if:

  • Male or female who are at least 18 years old
  • Patients with non-specific chronic lower back pain

You may not qualify if:

  • Mental or physical disabilities incompatible with focus groups/individual interviews and filling out questionnaires.
  • Inability to understand or speak French properly
  • Symptomatic lower back pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Motor ActivityTissue Adhesions

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

BehaviorCicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Emmanuel COUDEYRE

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2015

First Posted

June 9, 2015

Study Start

January 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

June 9, 2015

Record last verified: 2015-06

Locations

FR(1)