NCT05942196

Brief Summary

Physical exercise has a fundamental position in the chronic low back pain treatment. However, the physical activity level is often low in these patients and the adherence to the care program is not enough in the long term. The French Evaluation of the Perception of Physical Activity (EPPA) is a valid and reliable questionnaire, developed by N. Coste et al in 2020, that assesses the perceived barriers to and facilitators of physical activity in patients with knee osteoarthritis. To our knowledge, there is no valid and reliable instrument allowing such an assessment in chronic low back pain. The main objective of this study is to adapt the EPPA to chronic low back pain and to evaluate its psychometric properties. This validation would allow its use in current practice to adapt the care strategy, to personalize rehabilitation of each patient with chronic low back pain in order to have a better adherence to rehabilitation programs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

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

June 12, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 12, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2025

Completed
Last Updated

August 24, 2025

Status Verified

July 1, 2024

Enrollment Period

1.6 years

First QC Date

June 14, 2023

Last Update Submit

August 19, 2025

Conditions

Keywords

Chronic low back painPhysical activityPatient-reported outcomeFacilitatorsBarriersPsychometric properties

Outcome Measures

Primary Outcomes (4)

  • EPPA-LOMB

    Acceptability, internal validity, convergent validity, validity of structure against external criteria of the French questionnaire EPPA-LOMB.

    0 day

  • Change of EPPA-LOMB from baseline at 7 days

    Test-retest reliability of the French questionnaire EPPA-LOMB.

    0 day, 7 days

  • Change of EPPA-LOMB from baseline at 21 days

    Responsiveness of the French questionnaire EPPA-LOMB.

    0 day, 21 days

  • Change of EPPA-LOMB from baseline at 3 months

    Responsiveness of the French questionnaire EPPA-LOMB.

    0 day, 3 months

Secondary Outcomes (7)

  • Visual analogic scale for physical activity

    0 day, 7 days, 21 days, 3 months

  • Visual analogic scale for pain

    0 day, 7 days, 21 days, 3 months

  • OSWESTRY Disability Index (ODI)

    0 day, 21 days, 3 months

  • Fear Avoidance Belief Questionnaire (FABQ)

    0 day, 21 days, 3 months

  • Exercise Adherence Rating Scale (EARS)

    0 day, 21 days, 3 months

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with chronic low back pain seen in the Physical Medicine and Rehabilitation Department of the University Hospital of Clermont-Ferrand and in the Notre-Dame Functional Rehabilitation Center of Chamalières (France).

You may qualify if:

  • Adults (18 years old and older)
  • Patients with chronic low back pain evolving for at least 3 months, with a diagnosis confirmed by the French Health Authority and the classification from the French and European recommendations, that is lumbar pain, without red flags, with a possible pain radiculopathy
  • Acceptance to participate in the study.
  • Capable of providing informed consent to participate in this study.

You may not qualify if:

  • Patients not diagnosed according to the French Health Authority and the classification from the French and European recommendations
  • Refusal to participate
  • Patients in the incapacity to answer the questionnaires
  • Patients with a medical contraindication to physical activity
  • Patients under guardianship, or protection of justice.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

Related Publications (2)

  • Oliveira CB, Maher CG, Pinto RZ, Traeger AC, Lin CC, Chenot JF, van Tulder M, Koes BW. Clinical practice guidelines for the management of non-specific low back pain in primary care: an updated overview. Eur Spine J. 2018 Nov;27(11):2791-2803. doi: 10.1007/s00586-018-5673-2. Epub 2018 Jul 3.

    PMID: 29971708BACKGROUND
  • Bailly F, Trouvin AP, Bercier S, Dadoun S, Deneuville JP, Faguer R, Fassier JB, Koleck M, Lassalle L, Le Vraux T, Liesse B, Petitprez K, Ramond-Roquin A, Renard JF, Roren A, et al. Recommandations et arbre décisionnel sur la prise en charge de la lombalgie avec ou sans radiculalgie. Revue du Rhumatisme. 2022 ; 89 : 345-353.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Emmnauel COUDEYRE

    ecoudeyre@chu-clermontferrand.fr

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 14, 2023

First Posted

July 12, 2023

Study Start

June 12, 2023

Primary Completion

January 9, 2025

Study Completion

April 28, 2025

Last Updated

August 24, 2025

Record last verified: 2024-07

Locations