NCT02962817

Brief Summary

Aim: The primary aim of this project is to identify the fear-avoidance beliefs and attitudes of primary care physicians and nurses towards the treatment of chronic nonspecific low back pain to subsequently develop a biopsychosocial educational tool using a web platform. The secondary aim of this project is to evaluate the effectiveness of this educational intervention about pain neurophysiology and fear-avoidance beliefs, using a web platform for primary care physicians and nurses. Methods: Exploratory sequential mixed method design. For the qualitative phase of this study, researchers will use personal semistructured interviews. For the quantitative phase the authors will use an experimental study design. Subjects: medical and nursing staff working in primary care centers in the city of Lleida, Spain. Expected outcomes: the authors expect to change and modify wrong beliefs and attitudes about chronic low back pain of physicians and nurses working in primary care settings, using a web-based educational tool with the additional result of increasing knowledge on pain neurophysiology and reducing fear-avoidance beliefs.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 9, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

December 10, 2021

Status Verified

December 1, 2021

Enrollment Period

1.3 years

First QC Date

November 9, 2016

Last Update Submit

December 2, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Knowledge about the pain neurophysiology

    Using the pain neurophysiology questionnaire. This self-administered questionnaire was developed by Lorimer Moseley in 2003 to assess how an individual conceptualizes pain. An acceptable internal consistency and good test-retest reliability was demonstrated. The original English version was translated into Spanish by the Language Service of the Rovira and Virgili University. The questionnaire consists of 19 statements that refer to the origin and meaning of pain with three possible answers: true, false or doubtful. Each correct answer is scored with 1 point, while incorrect, doubtful or unanswered responses are scored with 0 points.

    2 weeks

Secondary Outcomes (2)

  • Fear-avoidance beliefs

    2 weeks

  • Fear-avoidance beliefs and attitudes

    2 weeks

Study Arms (2)

Educational intervention through a web platform

EXPERIMENTAL

This group will have access to our web platform where they will find information related to nonspecific chronic low back pain. This information will be presented through dynamic explanatory 3D videos made by the author. The aim of this intervention is to change and modify wrong beliefs and attitudes about chronic low back pain of physicians and nurses working in primary care settings, using a web-based educational tool with the additional result of increasing knowledge on pain neurophysiology and reducing fear-avoidance beliefs.

Other: Educational intervention

Clinical practice guidelines on low back pain

ACTIVE COMPARATOR

Control group: They will have access to a video where medical staff and primary care nurses explain the content of the clinical practice guideline for addressing back pain.

Other: Video explaining the clinical practice guidelines on low back pain

Interventions

Educational intervention through a web platform
Clinical practice guidelines on low back pain

Eligibility Criteria

Age22 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Graduated in medicine and specialized in family and community medicine.
  • Graduates in nursing.
  • Registered health professionals.
  • Professionals working in any of the primary care centers.
  • Accept and sign the informed consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primary care

Lleida, 25198, Spain

Location

Related Publications (2)

  • Garcia-Martinez E, Soler-Gonzalez J, Blanco-Blanco J, Rubi-Carnacea F, Masbernat-Almenara M, Valenzuela-Pascual F. Misbeliefs about non-specific low back pain and attitudes towards treatment by primary care providers in Spain: a qualitative study. BMC Prim Care. 2022 Jan 14;23(1):9. doi: 10.1186/s12875-021-01617-3.

  • Garcia-Martinez E, Soler-Gonzalez J, Rubi-Carnacea F, Garcia-Martinez B, Climent-Sanz C, Blanco-Blanco J, Valenzuela-Pascual F. The influence of an educational internet-based intervention in the beliefs and attitudes of primary care professionals on non-specific chronic low back pain: study protocol of a mixed methods approach. BMC Fam Pract. 2019 Feb 21;20(1):31. doi: 10.1186/s12875-019-0919-6.

MeSH Terms

Interventions

Early Intervention, Educational

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Francesc Valenzuela Pascual, BSc(PT)

    Universitat de Lleida

    STUDY DIRECTOR
  • Jorge Soler Gonzalez, MD

    Universitat de Lleida

    STUDY DIRECTOR
  • Ester García Martínez, BSc(PT)

    Universitat de Lleida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ester García Martínez, Faculty of Nursing and Physiotherapy, Universitat de Lleida

Study Record Dates

First Submitted

November 9, 2016

First Posted

November 11, 2016

Study Start

October 1, 2016

Primary Completion

February 1, 2018

Study Completion

June 1, 2022

Last Updated

December 10, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations