Improvement of Fear-avoidance Beliefs in Patients With Chronic Low Back Pain

April 24, 2024 updated by: Aníbal Báez Suárez, University of Las Palmas de Gran Canaria

Improvement of Fear-avoidance Beliefs in Patients With Chronic Non-specific Low Back Pain Treated at the Non-specific Low Back Pain Treated in the Back School

Non-specific chronic low back pain is the main cause of public spending on health care and labor, with a prevalence of 10.2%. Its therapeutic management is difficult, with moderate levels of pain and persistent disability over time, influenced by psychosocial factors, such as "fear-avoidance" beliefs. The supervised therapeutic exercise program associated with an educational component is one of the most effective interventions to reduce pain and disability in these patients, but its efficacy seems to be less if there are erroneous beliefs, avoidance attitudes, or fear of physical activity, since it makes it difficult to follow the recommendations. The Back School would address this problem, seeking to improve pain, disability and increase quality of life.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The main objective of this study is to evaluate the influence of the intervention of the Back School of the Hospital Universitario Insular de Gran Canaria in reducing the levels of "fear-avoidance" beliefs in patients with non-specific chronic low back pain.

Study Type

Interventional

Enrollment (Estimated)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Las Palmas
      • Las Palmas De Gran Canaria, Las Palmas, Spain, 35016
        • Recruiting
        • Sven Mikael Appelvik González
        • Sub-Investigator:
          • Aníbal Báez-Suárez, PhD
        • Contact:
        • Sub-Investigator:
          • Juan Francisco Loro Ferrer, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of non-specific low back pain, age 18-65 years, acceptance of voluntary participation and signature of the informed consent document.
  • Acceptance of voluntary participation and signature of the informed consent document.
  • Sufficient oral and written knowledge of the Spanish language
  • Absence of any other educational intervention at the present time.

Exclusion Criteria:

  • Presence or suspicion of red flags
  • Cognitive impairment
  • Spinal surgery
  • Intolerance to physical activity
  • Litigation pending resolution
  • Pregnancy or postpartum less than 6 months
  • Withdrawal from the study (signature of the informed consent revocation document).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise and Education Group
They will perform an exercise program oriented according to the back school, as well as educational guidelines related to pain.
Procedure: Exercise and Education Group
Physical exercise and pain education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the level of fear-avoidance beliefs.
Time Frame: Baseline and up to ten weeks

This variable will be recorded using the Spanish version of the Fear-Avoidance Belief Questionnaire (FABQ).

The FABQ contains 16 items. Each item is answered on a 7-point Likert scale (0 = strongly disagree; 6 = strongly agree). The FABQ-total represents the sum of all items (96 possible points). A higher score indicates more deeply held fear avoidance beliefs. There are two subscales within the FABQ: a subscale of Fear-Avoidance to physical activity, with 5 items (FABQ: items scoring 2, 3, 4 and 5; maximum score, 24), and another of Fear-Avoidance to work, with 11 items (FABQ: items scoring 6, 7, 9, 10, 11, 12 and 15; maximum score, 42). Its Spanish version has shown as good or better properties in the FABQ-total questionnaire than in its subscales to determine Fear-avoidance.
Baseline and up to ten weeks
Change in Pain assessed by VAS
Time Frame: Baseline and up to ten weeks

The instrument will be used to measure the change of pain before and after the intervention will be the Visual Analogue Scale (VAS).

Participants will be asked to mark the level of their pain on a 100 mm, no hatched VAS scale marked at one end as "no pain" and at the other as "worst pain imaginable".
Baseline and up to ten weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the level of disability
Time Frame: Baseline and up to ten weeks
The Oswestry Disability Index (ODI: 0-100, higher score indicates greater disability) (28) or Oswestry Disability Questionnaire for back pain, which is a widely used and validated instrument to measure disability related to low back pain (29,30), will be used as a measuring instrument. The questionnaire is focused on physical activities and does not evaluate the psychological or affective component of low back pain.
Baseline and up to ten weeks
Change in Sleep quality
Time Frame: Baseline and up to ten weeks

The Pittsburgh Sleep Quality Index (PSQI) will be used. It consists of 19 self-administered questions and 5 questions assessed by the patient's partner or roommate (if available). Only the self-administered questions are included in the score.

The higher the total score, the worse the sleep quality. Thus, a total score less than or equal to five on the Pittsburgh scale indicates that, in general, your sleep quality is optimal, while a total score greater than five suggests that you have sleep problems, of greater or lesser severity.
Baseline and up to ten weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Las Palmas de Gran Canaria

Investigators

  • Principal Investigator: Sven Mikael Appelvik González, MSc, University of Las Palmas de Gran Canaria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2023

Primary Completion (Estimated)

May 11, 2024

Study Completion (Estimated)

September 11, 2024

Study Registration Dates

First Submitted

November 11, 2023

First Submitted That Met QC Criteria

November 15, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPainEduca

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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