Confidence in the Ability to Perform Movements in Patients With Low Back Pain

NCT05860426 | Completed

• 1 other identifier: ULE-003-2021
• Study Type: observational
• Target: 141
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Low Back Ache; Lumbago; Self Efficacy; Kinesiophobia; Machine Learning

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Confidence at 3 months

  Outpatient Physical Therapy Improvement in Movement Assessment Log (OPTIMAL) instrument, confidence scale, spanish version. Total score ranges from 0-100 points, with higher scores indicating worse outcome (lower confidence).

  Recruitment, "physiotherapy discharge" (week 3) and 3 months later.

Secondary Outcomes (4)

• Change from Baseline Kinesiophobia at 3 months.

  Recruitment, "physiotherapy discharge" (week 3) and 3 months later.

• Change from Baseline Disability at 3 months.

  Recruitment, "physiotherapy discharge" (week 3) and 3 months later.

• Change from Baseline Risk at 3 months.

  Recruitment, "physiotherapy discharge" (week 3) and 3 months later.

• Change from Baseline Intensity of pain at 3 months.

  Recruitment, "physiotherapy discharge" (week 3) and 3 months later.

Other Outcomes (2)

• Self-Efficacy.

  Recruitment.

• Socio-demographic information.

  Recruitment.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de León: lead

Study Sites (1)

University of León

Ponferrada, León, 24400, Spain

Location

Related Publications (7)

• 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

• 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.

  PMID: 34719942 BACKGROUND

• 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.

  PMID: 15921473 BACKGROUND

• 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.

  PMID: 29860022 BACKGROUND

• 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.

  PMID: 25132307 BACKGROUND

• 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.

  PMID: 21296465 BACKGROUND

• 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.

  PMID: 18438893 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Kinesiophobia

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Arrate Pinto-Carral, Ph Dr

  Universidad de León

  STUDY DIRECTOR

• Mª José Álvarez-Álvarez, Ph Dr

  Universidad de León

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph. Dr. Teacher

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 16, 2023
• Study Start: November 2, 2022
• Primary Completion: February 1, 2024
• Study Completion: May 31, 2024
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)