Skip to main content
Clinical Trials/NCT06244602
NCT06244602
Completed
Not Applicable

Balance Assessment in Individuals With Chronic Pain: an Explorative Study of Psychometric Properties of the Mini-BESTest

Uppsala University1 site in 1 country73 target enrollmentFebruary 14, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Non-Cancer Pain
Sponsor
Uppsala University
Enrollment
73
Locations
1
Primary Endpoint
The Mini Balance Evaluation Systems Test (Mini-BESTest)
Status
Completed
Last Updated
4 months ago

Overview

Brief Summary

The goal of this observational study is to test psychometric properties of a clinical balance assessment scale, the Mini-BESTest, as well as to explore experiences and beliefs about balance and being balance tested. The main research questions are:

  • What is the test-retest reliability of the Mini-BESTest balance assessment scale for individuals with long-term pain?
  • What is the individual's subjective beliefs and experiences about their own balance and being balance tested with the Mini-BESTest?

Tow samples of participants will be included. One sample for a) the test-retest evaluation or b) an interview during and after performing the Mini-BESTest.

Detailed Description

Individuals with chronic pain, i.e., pain \> 3 months, report balance problems and falls in their everyday lives. How balance affects daily functioning, and how to identify individuals with balance impairments are less studied. The Mini-BESTest has previously shown adequate construct validity in individuals with chronic pain, however, the test-retest reliability has not been explored. There is also a need of studies that have focus on the person's own experiences of balance and the balance tested. In this observational study we aim to examine the psychometric properties of the Mini-BESTest, in individuals with chronic pain. Further we aim to explore individual subjective beliefs and experiences about own balance and being balance tested. A convenience selection will be used to include two samples of participants. One sample for the test-retest evaluation, here after called the test-retest part of the study. And one sample for a think aloud interview, here after called the interview part of the study. At baseline the participants will be included to one of the two parts. Participants in the test-retest part will be assessed with the Mini-BESTest on two occasions, the baseline and the re-test within approximately 2 weeks. The inclusion to the test-retest sample will continue until at least 50 individuals with no subjective experience of improvement or deterioration in balance status between the first and second occasions, according to the self-report measure the Patient global impression of change (PGIC), are included. This sampling is done in purpose to calculate test-retest reliability in individuals without subjective change in balance between the two occasions. To the interview part, approximately ten to twenty individuals will be included for concurrent think aloud, i.e., think aloud during balance testing with the Mini-BESTest, and recurrent think aloud, i.e., an interview after the balance assessment. The interviews will cover questions about the participants experience of the testing with the Mini-BESTest and their balance. Data will be collected by use of digitized questionnaires, physical performance tests, a structured interview and data from medical records. Statistical tests will be used to evaluate test-retest reliability and internal consistency. The interviews will be analyzed using thematic analysis.

Registry
clinicaltrials.gov
Start Date
February 14, 2024
End Date
December 16, 2024
Last Updated
4 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Uppsala University
Responsible Party
Principal Investigator
Principal Investigator

Pernilla Asenlof

Professor

Uppsala University

Eligibility Criteria

Inclusion Criteria

  • 18 years or older
  • pain duration of 3 months or more
  • a visit for investigation or treatment at the pain clinic

Exclusion Criteria

  • receiving acute care related to active cancer treatment
  • receiving palliative care
  • having cognitive impairments
  • illiterate in the Swedish language
  • wheelchair users or bed-bound
  • current participating in any of the rehabilitation programs at the pain clinic

Outcomes

Primary Outcomes

The Mini Balance Evaluation Systems Test (Mini-BESTest)

Time Frame: Baseline, 2 weeks

Self-report, Swedish version. Dynamic balance is measured with 14 items ranging from 0 = 'unable or requiring help to perform' to 2 = 'normal'. All items are summed up to a total score which ranges from 0 to 28, with higher scores reflecting better balance.

Secondary Outcomes

  • Numerical Rating Scales (NRS)(Baseline)
  • The Pain Disability Index (PDI)(Baseline)
  • Question about sedentary from the Swedish National Board of Health and Welfare(Baseline)
  • Numerical Rating Scale (NRS)(Baseline, 2 weeks)
  • Falls Efficacy Scale - international (FES-I)(Baseline, 2 weeks)
  • The Time Line Follow-Back (TLFB) Structured interview(Baseline)
  • The Public Health Agency of Sweden' questions about physical activity(Baseline)
  • Fall frequency(Baseline, 2 weeks)
  • 11-item Tampa Scale for Kinesiophobia (TSK-11)(Baseline)
  • Activities-Specific Balance Confidence (ABC) scale(Baseline, 2 weeks)
  • 2-item Pain Self-Efficacy Questionnaire (PSEQ-2)(Baseline)

Study Sites (1)

Loading locations...

Similar Trials