Clinical trial NCT06138158: Improvement of Fear-avoidance Beliefs in Patients with Chronic Low Back Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Specific Low Back Pain
Keywords: Pain
School Health Promotion
Medical Education
Exercise
Lead sponsor: University of Las Palmas de Gran Canaria
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Changes in the level of fear-avoidance beliefs.
timeFrame: Baseline and up to ten weeks
measure: Change in Pain assessed by VAS
timeFrame: Baseline and up to ten weeks
Secondary outcomes:
measure: Change in the level of disability
timeFrame: Baseline and up to ten weeks
measure: Change in Sleep quality
timeFrame: Baseline and up to ten weeks
Other outcomes:
Locations:
city: Las Palmas De Gran Canaria
country: Spain
facility: Sven Mikael Appelvik González
state: Las Palmas
Study officials:
affiliation: University of Las Palmas de Gran Canaria
name: Sven Mikael Appelvik González, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. Epub 2012 Mar 30.
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/NBK11702/
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 Musculoskelet Disord. 2010 Sep 17;11:212. doi: 10.1186/1471-2474-11-212.