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

NCT06138158 | Completed

• 1 other identifier: SPainEduca
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Specific Low Back Pain

Keywords

Pain; School Health Promotion; Medical Education; Exercise

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in the level of disability

  Baseline and up to ten weeks

• Change in Sleep quality

  Baseline and up to ten weeks

Study Arms (1)

Exercise and Education Group

EXPERIMENTAL

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

Interventions

Exercise and Education Group PROCEDURE

Physical exercise and pain education

Exercise and Education Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Las Palmas de Gran Canaria: lead

Study Sites (1)

Sven Mikael Appelvik González

Las Palmas de Gran Canaria, Las Palmas, 35016, Spain

Location

Related 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 nonspecific low back pain. Eur Spine J. 2006 Mar;15 Suppl 2(Suppl 2):S192-300. doi: 10.1007/s00586-006-1072-1. No abstract available.

  PMID: 16550448 BACKGROUND

• 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. Epub 2012 Mar 30.

  PMID: 22466247 BACKGROUND

• 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/NBK11702/

  PMID: 20704057 BACKGROUND

• 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 Musculoskelet Disord. 2010 Sep 17;11:212. doi: 10.1186/1471-2474-11-212.

  PMID: 20849601 BACKGROUND

MeSH Terms

Conditions

Pain; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sven Mikael Appelvik González, MSc

  University of Las Palmas de Gran Canaria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 11, 2023
• First Posted: November 18, 2023
• Study Start: November 11, 2023
• Primary Completion: October 11, 2024
• Study Completion: November 1, 2024
• Last Updated: November 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)