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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Non Specific Low Back Pain

Intervention / Treatment
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* Procedure: Exercise and Education Group


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise and Education Group<br>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<br>* Physical exercise and pain education<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the level of fear-avoidance beliefs. | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Pain, School Health Promotion, Medical Education