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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06109246
• Other study ID #: GaziosmanpasaU_Erol_09
• Status: Not yet recruiting
• Start date: October 26, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: October 2023
• Source: Tokat Gaziosmanpasa University
• Contact: Erkan Erol
• Phone: +905547920118
• Email: erkanerol[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 30, 2023
• Est. primary completion date: November 30, 2023
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Having low back pain for at least 3 months

Exclusion Criteria:

• Having acute pain

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Locations

Country	Name	City	State
Turkey	Faculty of Health Sciences, Tokat Gaziosmanpasa University	Tokat

Sponsors (1)

Lead Sponsor	Collaborator
Tokat Gaziosmanpasa University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Enablement Instrument for Back Pain	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.	Baseline
Primary	Patient Enablement Instrument for Back Pain	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.	After 1 week (retest)
Primary	The Brief Illness Perception Questionnaire	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.	Baseline
Primary	Fear-Avoidance Belief Questionnaire	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'.	Baseline
Primary	Oswestry Low Back Pain Disability Questionnaire	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.	Baseline
Primary	Short Form 36	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.	Baseline