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

Sponsor

University of Las Palmas de Gran Canaria (Other)

Overall Status

Recruiting

CT.gov ID

NCT06138158

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Non Specific Low Back Pain	Procedure: Exercise and Education Group	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

39 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 11, 2023

Anticipated Primary Completion Date :

Mar 11, 2024

Anticipated Study Completion Date :

Jun 11, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Changes in the level of fear-avoidance beliefs. [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.
Change in Pain assessed by VAS [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".

Secondary Outcome Measures

Change in the level of disability [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.
Change in Sleep quality [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).