The Patient Enablement Instrument for Back Pain Turkish Version, Validity and Reliability Study

Sponsor
Tokat Gaziosmanpasa University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06109246
Collaborator
(none)
60
1
2.1
28.1

Study Details

Study Description

Brief Summary

Most people experience low back pain at some point in their lives, and most low back pain is classified as nonspecific because the factor causing the pain cannot be identified. Current guidelines recommend self-management interventions for the management of nonspecific low back pain. The most commonly used assessment measures measure pain, disability, and quality of life. However, it is important to evaluate patients' ability to manage their nonspecific LBP-specific disease.

In 1997, Howie and colleagues introduced the concept of enablement, which represents patients' enablement, understanding of, and ability to cope with their health and illness. They developed the "The Patient Enablement Instrument" to measure patient competence based on the theory that if patients' competence increases, other important outcomes will improve. The Patient Enablement Instrument has since been translated into many languages and has generally demonstrated moderate to good validity and reliability. However, there are limitations to using the Patient Enablement Instrument as an outcome measure.

Inspired by the Patient Enablement Instrument, researchers from Denmark and Sweden developed the Patient Enablement Instrument for Back Pain , which could potentially be used as an outcome measure for interventions aimed at improving self-management in people seeking treatment for low back pain. In 2021, Nielsen et al. The validity and reliability of the scale was determined by and its use was recommended in the population experiencing low back pain. The aim of our study is to culturally adapt the Patient Enablement Instrument for Back Pain into Turkish and to examine its validity and reliability.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    The Patient Enablement Instrument for Back Pain Turkish Version, Validity and Reliability Study
    Anticipated Study Start Date :
    Oct 26, 2023
    Anticipated Primary Completion Date :
    Nov 30, 2023
    Anticipated Study Completion Date :
    Dec 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Patient Enablement Instrument for Back Pain [Baseline]

      Each question is given a score between 0 and 10, allowing changes in the patient to be measured more sensitively. On a 0-10 numerical rating scale, 0 = "to a very low degree" and 10 = "to a very high degree". The maximum total score that can be obtained is 60, and higher scores indicate higher enablement.

    2. Patient Enablement Instrument for Back Pain [After 1 week (retest)]

      Each question is given a score between 0 and 10, allowing changes in the patient to be measured more sensitively. On a 0-10 numerical rating scale, 0 = "to a very low degree" and 10 = "to a very high degree". The maximum total score that can be obtained is 60, and higher scores indicate higher enablement.

    3. The Brief Illness Perception Questionnaire [Baseline]

      The scale consists of eight items. The eighth item on the scale questions the causal factors of the disease. The other 7 items in the scale have a Likert-type scoring scale from 0 to 10.

    4. Fear-Avoidance Belief Questionnaire [Baseline]

      It is a 16-item scale. It consists of 2 parts; The first part evaluates fear-avoidance attitudes related to physical activity, and the second part evaluates fear-avoidance attitudes related to work. Items with a 7-point Likert type receive a minimum of 0 points when the patient chooses the statement 'I completely disagree' and a maximum of 6 points when the patient chooses the statement 'I completely agree'.

    5. Oswestry Low Back Pain Disability Questionnaire [Baseline]

      It is a measurement method that evaluates daily life activities and consists of 10 questions. Questions include pain severity, personal care, weight lifting, walking, sitting, standing, sleep status, sexual and social life, and traveling. Each question consists of six items and is scored between 0-5.

    6. Short Form 36 [Baseline]

      The subscales of the scale are: physical function (10 items), social function (2 items), role limitations due to physical functions (4 items), role limitations due to emotional problems 31 (3 items), mental health (5 items), energy (4 items). item), pain (2 items) and general perception of health (5 items). Subscales evaluate health between 0 and 100, with 0 indicating the lowest quality of life and 100 indicating the highest quality of life.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Having low back pain for at least 3 months
    Exclusion Criteria:
    • Having acute pain

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Health Sciences, Tokat Gaziosmanpaşa University Tokat Turkey

    Sponsors and Collaborators

    • Tokat Gaziosmanpasa University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Erkan Erol, Assistant Professor, Tokat Gaziosmanpasa University
    ClinicalTrials.gov Identifier:
    NCT06109246
    Other Study ID Numbers:
    • GaziosmanpasaU_Erol_09
    First Posted:
    Oct 31, 2023
    Last Update Posted:
    Oct 31, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 31, 2023