Test-retest and Experiences During Balance Assessment With the Mini-BESTest

Chronic Non-Cancer Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06244602
• Other study ID #: 2023-04206-01
• Status: Recruiting
• Start date: February 14, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: Uppsala University
• Contact: Pernilla Åsenlöf, Professor
• Phone: +46704562831
• Email: pernilla.aselof[@]uu.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Non-Cancer Pain
• Chronic Pain

Locations

Country	Name	City	State
Sweden	Uppsala University and University Hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient global impression of change (PGIC)	Self-report. The measure reflects participant's beliefs about if there balance has changed between baseline and the re-test of Mini-BESTest. The participant indicates whether he/she feels that his/her balance has changed since the previous session of the study on a 7-point scale, 'very much improved', 'much improved', 'minimally improved', 'no change', 'minimally worse', 'much worse', 'very much worse'.	2 weeks
Other	Change in medication	Self-report questions on change in medication between baseline and the re-test of the Mini-BESTest. The participant indicates whether the type of medication or dose has changed since the previous study visit, the name of the changes medicine, and whether the medicine has been 'added' or 'removed', as well as if the dose has 'increased', 'decreased' or if the participant 'doesn't know'.	2 weeks
Primary	The Mini Balance Evaluation Systems Test (Mini-BESTest)	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.	Baseline, 2 weeks
Secondary	Numerical Rating Scale (NRS)	Self-report, oral question. Current pain intensity is measured with a scale that ranges from 0-10, where 0 = 'no pain' and 10 = 'pain as bad as can be'.	Baseline, 2 weeks
Secondary	Fall frequency	Self-report, question about fall frequencies over the last previous year and the last three weeks.	Baseline, 2 weeks
Secondary	Activities-Specific Balance Confidence (ABC) scale	Self-report, Swedish version. Balance confidence is measured with 16 items ranging from 0 = 'No confidence' to 100 = 'Full confidence'. All items are summed up to a total score, which ranges from 0 to 100, with higher scores reflecting higher balance confidence while doing activities.	Baseline, 2 weeks
Secondary	Falls Efficacy Scale - international (FES-I)	Self-report, Swedish version. Fear of falling is measured with 16 items ranging from 1 = 'Not at all concerned' to 4 = 'Very concerned'. All items are summed up to a total score, which ranges from 16 to 64, with higher scores reflecting more concerns about falling.	Baseline, 2 weeks
Secondary	Numerical Rating Scales (NRS)	Self-report. Pain severity is measured with four scales where worst, least, average and current pain during the past week are scored. Each scale ranges from 0-10, where 0 = 'no pain' and 10 = 'pain as bad as can be'.	Baseline
Secondary	The Pain Disability Index (PDI)	Self-report, Swedish version. Pain-related disability is measured with 7 items measuring family/home responsibilities, recreation, social activity, occupation, sexual behavior, self-care and life support activity. Every item ranges from 0 = 'No disability' to 10 = 'Worst disability'. All seven items are summed up in a total score, which ranges from 0 to 70, with higher scores reflecting higher interference of pain with daily activities.	Baseline
Secondary	2-item Pain Self-Efficacy Questionnaire (PSEQ-2)	Self-report, Swedish version. Pain self-efficacy is measured with 2 items ranging from 0 = 'Not at all confident' to 6 = ' Completely confident', with a higher combined scores indicating stronger self-efficacy beliefs.	Baseline
Secondary	11-item Tampa Scale for Kinesiophobia (TSK-11)	Self-report, Swedish version. Fear of movement and reinjury is measured by 11 items ranging from 1 = 'Does not agree at al' to 4 = 'totally agree). A total score is calculated ranging from 11 to 44 where higher scores indicates higher fear of movement.	Baseline
Secondary	The Public Health Agency of Sweden' questions about physical activity	Self-report. Minutes of physical activity on low intensity and moderate intensity is measured with two ordinal scales.	Baseline
Secondary	Question about sedentary from the Swedish National Board of Health and Welfare	Self-report. Hours of sedentary behavior measured on an ordinal scale.	Baseline
Secondary	The Time Line Follow-Back (TLFB) Structured interview	Patterns of opioid use (type of opioid, dose, and duration) will be measured using a structured interview, calendar format, using 4 weeks intervals starting with the most recent complete week, week 1, working backward one week at time recording days of use for each opioid.	Baseline