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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Chee Wee Tan, PhD contact

+131 331 8038

cheeweetan.uk@gcu.ac.uk

United Kingdom1 site, 1 recruiting
  • Glasgow Caledonian University

    Glasgow

    Chee Wee Tan, PhD, +131 331 8038, cheeweetan.uk@gcu.ac.uk

    Paul Cameron, PhD

    Recruiting

Other trials in United Kingdom

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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  1. First posted22 Apr 2021
  2. Study start1 Dec 2020
  3. Primary completion30 Jun 2021 (estimated)
  4. Study completion30 Jun 2021 (estimated)

Resources

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)
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

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.

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