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Non Specific Low Back PainNCT06138158

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

A study testing Exercise and Education Group in people with Non Specific Low Back Pain, run by University of Las Palmas de Gran Canaria at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Non Specific Low Back Pain
What is being tested?
Exercise and Education Group
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteSpain
Study dates
11 Nov 2023to 1 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Sven Mikael Appelvik González

    Las Palmas de Gran Canaria, Las Palmas, 35016

Other trials in Spain

About this study

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

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.

Read the 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.

Being tested
Exercise and Education Group
Keywords
Pain, School Health Promotion, Medical Education, Exercise
Medical subject headings
Pain, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise and Education GroupProcedure or surgery

    Physical exercise and pain education

Study groups in NCT06138158
Study groupRoleWhat they receive
Exercise and Education GroupExperimentalThey will perform an exercise program oriented according to the back school, as well as educational guidelines related to pain.
Receives: Procedure: Exercise and Education Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and up to ten weeks

  2. 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".

    Measured: Baseline and up to ten weeks

Secondary outcomes (2)

  1. 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.

    Measured: Baseline and up to ten weeks

  2. 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.

    Measured: Baseline and up to ten weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2023
  2. Study start11 Nov 2023
  3. Primary completion11 Oct 2024
  4. Study completion1 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06138158
Sponsor's protocol ID
SPainEduca
Status last verified
Aug 2024
First submitted
11 Nov 2023
Last updated
5 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 16550448

  • 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.

    PubMed 22466247

  • 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/

    PubMed 20704057

  • 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.

    PubMed 20849601

Questions about this trial

What is this clinical trial studying?

A study testing Exercise and Education Group in people with Non Specific Low Back Pain, run by University of Las Palmas de Gran Canaria at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in the level of fear-avoidance beliefs. (time frame: Baseline and up to ten weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06138158, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.

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