- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04855461
Understanding the Determinants of Physical Activity Levels in Persons With Chronic Pain
May 28, 2021 updated by: Glasgow Caledonian University
The proposed research topic will investigate the determinants of physical activity (PA) levels in patients with chronic pain.
The aim of the research project is to quantify the self-reported and free-living physical activity levels in people with chronic pain.
Describe and explore the characteristics and relationships of these participants in terms of pain severity, fear of movement, patterns of activity, anxiety and depression, and number and differing types of long term conditions and how these all correlate with PA levels.
Explore PA levels of chronic pain patients and the correlation of psychosocial factors.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chee Wee Tan, PhD
- Phone Number: +131 331 8038
- Email: cheeweetan.uk@gcu.ac.uk
Study Locations
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Glasgow, United Kingdom
- Recruiting
- Glasgow Caledonian University
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Contact:
- Chee Wee Tan, PhD
- Phone Number: +131 331 8038
- Email: cheeweetan.uk@gcu.ac.uk
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Sub-Investigator:
- Paul Cameron, PhD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
People with chronic pain
Description
Inclusion Criteria:
- Individuals with pain lasting more than 12 weeks (chronic pain)
- 16 years or older
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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International Physical Activity Questionnaire - Short Form
Time Frame: Entire duration of study- 6 months
|
The International Physical Activity Questionnaire -Short Form measures free-living physical activity levels.
The questionnaire is psychometrically tested and used as an instrument to measure physical activity over the previous seven days of participants.
It was developed in 1998 to investigate physical activity levels based on the global standard.
The IPAQ short form has demonstrated to have acceptable measurement properties for use in a variety of settings.
The nine item instrument asks for time spent in walking, moderate and vigorous intensity physical activity of at least 10-minute durations.
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Entire duration of study- 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Demographics questionnaire
Time Frame: Entire duration of study - 6 months
|
The demographics questionnaire will collect information about the participants' age, gender, nationality, ethnicity, duration of condition, living environment.
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Entire duration of study - 6 months
|
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Brief Pain Inventory - Short Form
Time Frame: Entire duration of study - 6 months
|
The Brief Pain Inventory - Short Form (BPI-SF) is a widely used questionnaire used with persons with chronic non-malignant painful conditions.
It is composed of a nine-item self-administered questionnaire to evaluate the severity of an individuals' pain and impact on their daily function.
The BPI-SF required participants to rate their current pain intensity, pain in the last 24 hours at its worst, least and average by using a numerical scale of 0-10.
Participants are also asked to rate the extent to which their pain interferes with seven quality of life domains.
The scales to these domains are bound by words "does not interfere" and "interferes completely".
The reliability has been reported in several chronic pain conditions.
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Entire duration of study - 6 months
|
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The Patterns of Activity Measure - Pain
Time Frame: Entire duration of study - 6 months
|
The Patterns of Activity Measure -Pain (POAM-P) measures pacing/pattern of activity.
The questionnaire is composed of 30 self-reported items developed by Cane et al 2007 to measure three activity patterns; avoidance, overdoing and pacing in patients with chronic pain.
Each subscale consists of 10 items, where participants are given instructions such as: "People who have pain use different ways to do their daily activity.
This about how you do your daily activity".
Participants will then rate the statement as to the extent it applies to them on a five-point scale ranging from 0 (not at all) to 4 (always), each subscale ranges in score from 0-40.
The POAM-P scale for pacing has shown acceptable psychometric properties.
|
Entire duration of study - 6 months
|
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The Tampa Scale of Kinesiophobia
Time Frame: Entire duration of study - 6 months
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The Tampa Scale of Kinesiophobia (TSK) is a 17 item self-completed questionnaire that will be used to assess the subjective rating of kinesiophobia or fear of movement.
The TSK was originally developed to differentiate between non-excessive fear and phobia among patients with musculoskeletal pain.
It has been deemed a valid and reliable psychometric measure used for pain relating to different body parts.
The scores of the questionnaire ranged from 17 to 68 where higher scores indicate a higher degree of kinesiophobia.
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Entire duration of study - 6 months
|
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The Depression, Anxiety and Stress Scale - 42
Time Frame: Entire duration of study - 6 months
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The Depression, Anxiety and Stress Scale - 42 (DASS-42) is a 42-item self-report instrument that consists of three scales that assess three negative emotional states of depression, anxiety and stress over the last week.
Each of the 42 items has four responses ranging from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time).
The DASS42 requires participants to respond to statements immediately in relation to their feelings of the previous week.
Higher scores relate to higher levels of depression, anxiety or stress.
Previous findings showed that DASS42 has reliable psychometric properties in relation to internal consistency, convergent and discriminant validity in clinical and non-clinical populations.
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Entire duration of study - 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chee Wee Tan, PhD, Glasgow Caledonian University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2020
Primary Completion (Anticipated)
June 30, 2021
Study Completion (Anticipated)
June 30, 2021
Study Registration Dates
First Submitted
April 19, 2021
First Submitted That Met QC Criteria
April 21, 2021
First Posted (Actual)
April 22, 2021
Study Record Updates
Last Update Posted (Actual)
June 2, 2021
Last Update Submitted That Met QC Criteria
May 28, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EC1_CWT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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