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

Non Specific Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06138158
• Other study ID #: SPainEduca
• Status: Recruiting
• Phase: N/A
• Start date: November 11, 2023
• Est. completion date: September 11, 2024

Study information

• Verified date: April 2024
• Source: University of Las Palmas de Gran Canaria
• Contact: Sven Mikael Appelvik González, MSc
• Phone: +34 928452701
• Email: mikael.appelvik[@]ulpgc.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 39
• Est. completion date: September 11, 2024
• Est. primary completion date: May 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Non Specific Low Back Pain

Intervention

Procedure:
• Exercise and Education Group
Physical exercise and pain education

Locations

Country	Name	City	State
Spain	Sven Mikael Appelvik González	Las Palmas De Gran Canaria	Las Palmas

Sponsors (1)

Lead Sponsor	Collaborator
University of Las Palmas de Gran Canaria

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, Klaber-Moffett J, Kovacs F, Mannion AF, Reis S, Staal JB, Ursin H, Zanoli G; COST B13 Working Group on Guidelines for Chronic Low Back Pain. Chapter 4. European guidelines for the management of chronic no — View Citation

Delitto A, George SZ, Van Dillen L, Whitman JM, Sowa G, Shekelle P, Denninger TR, Godges JJ; Orthopaedic Section of the American Physical Therapy Association. Low back pain. J Orthop Sports Phys Ther. 2012 Apr;42(4):A1-57. doi: 10.2519/jospt.2012.42.4.A1. — View Citation

National Collaborating Centre for Primary Care (UK). Low Back Pain: Early Management of Persistent Non-specific Low Back Pain [Internet]. London: Royal College of General Practitioners (UK); 2009 May. Available from http://www.ncbi.nlm.nih.gov/books/NBK11 — View Citation

Sorensen PH, Bendix T, Manniche C, Korsholm L, Lemvigh D, Indahl A. An educational approach based on a non-injury model compared with individual symptom-based physical training in chronic LBP. A pragmatic, randomised trial with a one-year follow-up. BMC M — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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