Chronic Non-Cancer PainNCT06244602
Test-retest and Experiences During Balance Assessment With the Mini-BESTest
An observational study of Chronic Non-Cancer Pain, run by Uppsala University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Non-Cancer Pain
- How many people
- 73 participants
- Where
- 1 siteSweden
- Study dates
- 14 Feb 2024to 16 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will include individuals with chronic pain referred to or in specialized pain care.
Who may be able to join
- 18 years or older
- pain duration of 3 months or more
- a visit for investigation or treatment at the pain clinic
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Balance Assessment in Individuals With Chronic Pain: an Explorative Study of Psychometric Properties of the Mini-BESTest
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.
Read the 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.
- Conditions
- Chronic Non-Cancer Pain
- Keywords
- Postural Balance, Chronic pain, Psychometrics, Experiences, Test-retest
- Medical subject headings
- Chronic Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 2 weeks
Secondary outcomes (11)
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'.
Measured: Baseline, 2 weeks
Fall frequency
Self-report, question about fall frequencies over the last previous year and the last three weeks.
Measured: Baseline, 2 weeks
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.
Measured: Baseline, 2 weeks
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.
Measured: Baseline, 2 weeks
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'.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
Question about sedentary from the Swedish National Board of Health and Welfare
Self-report. Hours of sedentary behavior measured on an ordinal scale.
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start14 Feb 2024
- Primary completion16 Dec 2024
- Study completion16 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Non-Cancer PainStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pernilla Asenlof, Uppsala University
- Investigators
- Pernilla Åsenlöf, Professor, Principal investigator, Uppsala University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06244602
- Sponsor's protocol ID
- 2023-04206-01
- Other IDs
- 2023
- Status last verified
- Dec 2025
- First submitted
- 29 Jan 2024
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balance Assessment in Individuals With Chronic Pain: an Explorative Study of Psychometric Properties of the Mini-BESTest
- ClinicalTrials.gov ID
- NCT06244602
- Acronym / sponsor ID
- 2023-04206-01
- Conditions
- Chronic Non-Cancer Pain
- Keywords
- Postural Balance, Chronic pain, Psychometrics, Experiences, Test-retest
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- 16 Dec 2024 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 6 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include individuals with chronic pain referred to or in specialized pain care.
Key inclusion criteria (3 listed)
- 18 years or older
- pain duration of 3 months or more
- a visit for investigation or treatment at the pain clinic
Key exclusion criteria (6 listed)
- receiving acute care related to active cancer treatment
- receiving palliative care
- having cognitive impairments
- illiterate in the Swedish language
- wheelchair users or bed-bound
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
11 secondary outcomes
Numerical Rating Scale (NRS)
Time frame: Baseline, 2 weeks
Fall frequency
Time frame: Baseline, 2 weeks
Activities-Specific Balance Confidence (ABC) scale
Time frame: Baseline, 2 weeks
Falls Efficacy Scale - international (FES-I)
Time frame: Baseline, 2 weeks
Numerical Rating Scales (NRS)
Time frame: Baseline
The Pain Disability Index (PDI)
Time frame: Baseline
2-item Pain Self-Efficacy Questionnaire (PSEQ-2)
Time frame: Baseline
11-item Tampa Scale for Kinesiophobia (TSK-11)
Time frame: Baseline
The Public Health Agency of Sweden' questions about physical activity
Time frame: Baseline
Question about sedentary from the Swedish National Board of Health and Welfare
Time frame: Baseline
The Time Line Follow-Back (TLFB) Structured interview
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pernilla Åsenlöf, Professor principal investigator
Uppsala University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Non-Cancer Pain, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Mini Balance Evaluation Systems Test (Mini-BESTest) (time frame: Baseline, 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.