Clinical trial NCT05860426: Confidence in the Ability to Perform Movements in Patients With Low Back Pain
Official title: Assessment of Confidence in the Ability to Perform Movements in Patients With Low Back Pain and Its Relationship With the Characteristics and Evolution of Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Low Back Pain
Keywords: Low Back Ache
Lumbago
Self Efficacy
Kinesiophobia
Machine Learning
Lead sponsor: Universidad de León
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients assigned to primary and specialized care health centers in the province of Leon (Spain), who were diagnosed with low back pain by their referring physician.

Brief summary: The goals of this observational study are:

To determine the validity and reliability of the OPTIMAL-confidence scale in people with chronic low back pain.

To assess the influence of confidence and fear of movement on the evolution of low back pain.

The main question it aims to answer is if people with chronic low back pain present different psychoemotional variables around fear of movement and decreased confidence in their ability to perform movement that may influence their low back pain.

For this purpose, a two-phase study was designed. In the first phase, the OPTIMAL-confidence scale will be validated in patients with chronic low back pain, determining its internal consistency and validity. In the second phase, a prospective study will be carried out with patients with low back pain who attend physiotherapy centres to determine how confidence and fear of movement influence the characteristics of pain and its evolution. Data will be collected at the beginning of the physiotherapy treatment, at the end of the treatment and after three months. The data will be analysed using learning machine techniques.

Detailed description: In the first phase of the study, a sample of patients diagnosed with chronic low back pain will bwe selected, as well as a general population of convenience. The scope of the study is the health centres of the Primary Care Management of León and El Bierzo. To calculate the optimal sample size, the criteria included in the COSMIN20 guide (Consensus-based standards for the selection of health measurement instruments) were taken into account, taking as a reference the maximum quality criterion for hypotheses testing, which states that they should be equal to or greater than 100 subjects.

The second phase will consist of a prospective observational study among patients with low back pain selected by physiotherapists and interested in participating in the study. Data will be collected at three different times: at recruitment and at the end of treatment, in person, and three months after the end of treatment, by telephone.

The scope of the study will be the Primary and Specialised Health Care Departments of León and El Bierzo.

In both cases participants will sign an informed consent form and the physiotherapists who will collect the data will be trained by researchers.

Patients will complete socio-demographic and health questions as well as validated questionnaires on confidence, self-efficacy, fear of movement, risk of chronification and disability. Participants in the second phase will complete the questionnaires not only at the beginning, but two more times.

In the validation phase of optimal-confidence, the internal consistency of the scale will be analysed, as well as convergent and known-groups validity.

In the second phase, the data will be analysed using machine learning techniques. In order to find out which variables are most influential in the evolution of low back pain, different variations of the following machine learning techniques will be used: Gaussian Naive Bayes, Complement Naive Bayes, K-Nearest Neighbours (KNN and decision trees. Experiments using oversampling techniques such as RandomOver and Smote will also be carried out.

Eligibility criteria: Inclusion Criteria:

* Patients with low back pain.
* Be able to read and understand Spanish.
* Acceptance and signature of the informed consent.

Exclusion Criteria:

* Tumor and/or infection related to the back.
* Cauda equina syndrome.
* Vertebral compression fracture.
* Abdominal aneurysm.
* Central nervous system disorders.
* Confirmed diagnosis of active neoplasm.
* Presence of cognitive deficits that prevented participation in the study.
* Pregnant patients in the last year.

Primary outcomes:
measure: Change from Baseline Confidence at 3 months
timeFrame: Recruitment, "physiotherapy discharge" (week 3) and 3 months later.
Secondary outcomes:
measure: Change from Baseline Kinesiophobia at 3 months.
timeFrame: Recruitment, "physiotherapy discharge" (week 3) and 3 months later.
measure: Change from Baseline Disability at 3 months.
timeFrame: Recruitment, "physiotherapy discharge" (week 3) and 3 months later.
measure: Change from Baseline Risk at 3 months.
timeFrame: Recruitment, "physiotherapy discharge" (week 3) and 3 months later.
measure: Change from Baseline Intensity of pain at 3 months.
timeFrame: Recruitment, "physiotherapy discharge" (week 3) and 3 months later.
Other outcomes:
measure: Self-Efficacy.
timeFrame: Recruitment.
measure: Socio-demographic information.
timeFrame: Recruitment.
Locations:
city: Ponferrada
country: Spain
facility: University of León
state: León
Study officials:
affiliation: Universidad de León
name: Arrate Pinto-Carral, Ph Dr
role: STUDY_DIRECTOR
affiliation: Universidad de León
name: Mª José Álvarez-Álvarez, Ph Dr
role: STUDY_DIRECTOR
References:
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: George SZ, Fritz JM, Silfies SP, Schneider MJ, Beneciuk JM, Lentz TA, Gilliam JR, Hendren S, Norman KS. Interventions for the Management of Acute and Chronic Low Back Pain: Revision 2021. J Orthop Sports Phys Ther. 2021 Nov;51(11):CPG1-CPG60. doi: 10.2519/jospt.2021.0304.
citation: Guccione AA, Mielenz TJ, Devellis RF, Goldstein MS, Freburger JK, Pietrobon R, Miller SC, Callahan LF, Harwood K, Carey TS. Development and testing of a self-report instrument to measure actions: outpatient physical therapy improvement in movement assessment log (OPTIMAL). Phys Ther. 2005 Jun;85(6):515-30.
citation: Pinto-Carral A, Fernandez-Villa T, Guccione AA, Cuadrado FM, Cancela JM, Molina AJ. Validity, Reliability, and Responsiveness of the Spanish Version of the OPTIMAL Instrument. PM R. 2019 Mar;11(3):258-269. doi: 10.1016/j.pmrj.2018.05.021. Epub 2019 Jan 22.
citation: Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, Carrino J, Chou R, Cook K, DeLitto A, Goertz C, Khalsa P, Loeser J, Mackey S, Panagis J, Rainville J, Tosteson T, Turk D, Von Korff M, Weiner DK. Report of the NIH Task Force on research standards for chronic low back pain. Pain Med. 2014 Aug;15(8):1249-67. doi: 10.1111/pme.12538.
citation: Gusi N, del Pozo-Cruz B, Olivares PR, Hernandez-Mocholi M, Hill JC. The Spanish version of the "STarT Back Screening Tool" (SBST) in different subgroups. Aten Primaria. 2011 Jul;43(7):356-61. doi: 10.1016/j.aprim.2010.05.019. Epub 2011 Feb 5.
citation: Hill JC, Dunn KM, Lewis M, Mullis R, Main CJ, Foster NE, Hay EM. A primary care back pain screening tool: identifying patient subgroups for initial treatment. Arthritis Rheum. 2008 May 15;59(5):632-41. doi: 10.1002/art.23563.