Clinical trial NCT06244602: Test-retest and Experiences During Balance Assessment With the Mini-BESTest
Official title: Balance Assessment in Individuals With Chronic Pain: an Explorative Study of Psychometric Properties of the Mini-BESTest
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Non-Cancer Pain
Keywords: Postural Balance
Chronic pain
Psychometrics
Experiences
Test-retest
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will include individuals with chronic pain referred to or in specialized pain care.

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.

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

Primary outcomes:
measure: The Mini Balance Evaluation Systems Test (Mini-BESTest)
timeFrame: Baseline, 2 weeks
Secondary outcomes:
measure: Numerical Rating Scale (NRS)
timeFrame: Baseline, 2 weeks
measure: Fall frequency
timeFrame: Baseline, 2 weeks
measure: Activities-Specific Balance Confidence (ABC) scale
timeFrame: Baseline, 2 weeks
measure: Falls Efficacy Scale - international (FES-I)
timeFrame: Baseline, 2 weeks
measure: Numerical Rating Scales (NRS)
timeFrame: Baseline
measure: The Pain Disability Index (PDI)
timeFrame: Baseline
measure: 2-item Pain Self-Efficacy Questionnaire (PSEQ-2)
timeFrame: Baseline
measure: 11-item Tampa Scale for Kinesiophobia (TSK-11)
timeFrame: Baseline
measure: The Public Health Agency of Sweden' questions about physical activity
timeFrame: Baseline
measure: Question about sedentary from the Swedish National Board of Health and Welfare
timeFrame: Baseline
measure: The Time Line Follow-Back (TLFB) Structured interview
timeFrame: Baseline
Other outcomes:
measure: Patient global impression of change (PGIC)
timeFrame: 2 weeks
measure: Change in medication
timeFrame: 2 weeks
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University and University Hospital
Study officials:
affiliation: Uppsala University, Sweden
name: Pernilla Åsenlöf, Professor
role: PRINCIPAL_INVESTIGATOR
References: