Chronic PainNCT04855461
Understanding the Determinants of Physical Activity Levels in Persons With Chronic Pain
An observational study of Chronic Pain, run by Glasgow Caledonian University at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Chronic Pain
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2020to 30 Jun 2021
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: People with chronic pain
Who may be able to join
- Individuals with pain lasting more than 12 weeks (chronic pain)
- 16 years or older
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Glasgow Caledonian University
Glasgow
Chee Wee Tan, PhD, +131 331 8038, cheeweetan.uk@gcu.ac.uk
Paul Cameron, PhD
About this study
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.
- Conditions
- Chronic Pain
- Keywords
- Physical Activity, Fear of Movement, Patterns of activity, Psychological status
- Medical subject headings
- Chronic Pain, Motor Activity, Kinesiophobia
What is being measured
The primary outcome is the main question the study is designed to answer.
International Physical Activity Questionnaire - Short Form
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.
Measured: Entire duration of study- 6 months
Secondary outcomes (5)
Demographics questionnaire
The demographics questionnaire will collect information about the participants' age, gender, nationality, ethnicity, duration of condition, living environment.
Measured: Entire duration of study - 6 months
Brief Pain Inventory - Short Form
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.
Measured: Entire duration of study - 6 months
The Patterns of Activity Measure - Pain
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.
Measured: Entire duration of study - 6 months
The Tampa Scale of Kinesiophobia
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.
Measured: Entire duration of study - 6 months
The Depression, Anxiety and Stress Scale - 42
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.
Measured: Entire duration of study - 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start1 Dec 2020
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glasgow Caledonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chee Wee Tan, PhD, Principal investigator, Glasgow Caledonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04855461
- Sponsor's protocol ID
- EC1_CWT
- Status last verified
- May 2021
- First submitted
- 19 Apr 2021
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Determinants of Physical Activity Levels in Persons With Chronic Pain
- ClinicalTrials.gov ID
- NCT04855461
- Acronym / sponsor ID
- EC1_CWT
- Conditions
- Chronic Pain
- Keywords
- Physical Activity, Fear of Movement, Patterns of activity, Psychological status
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Glasgow Caledonian UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 22 Apr 2021 (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 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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People with chronic pain
Key inclusion criteria (2 listed)
- Individuals with pain lasting more than 12 weeks (chronic pain)
- 16 years or older
Key exclusion criteria (1 listed)
- None
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
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.
5 secondary outcomes
Demographics questionnaire
Time frame: Entire duration of study - 6 months
Brief Pain Inventory - Short Form
Time frame: Entire duration of study - 6 months
The Patterns of Activity Measure - Pain
Time frame: Entire duration of study - 6 months
The Tampa Scale of Kinesiophobia
Time frame: Entire duration of study - 6 months
The Depression, Anxiety and Stress Scale - 42
Time frame: Entire duration of study - 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Individual participant dataSharing planned: No
Related trials for Chronic Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
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.
Chee Wee Tan, PhD principal investigator
Glasgow Caledonian University
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 Pain, run by Glasgow Caledonian University at 1 site in United Kingdom.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Jun 2021. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chee Wee Tan, PhD (+131 331 8038, cheeweetan.uk@gcu.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Physical Activity Questionnaire - Short Form (time frame: Entire duration of study- 6 months). 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 2 Jun 2021.