- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05114317
Characteristics of Pain in Women With Lipoedema
Pain Characteristics, Intensity, Patterns, Impact and Quality of Life in Women With Lipoedema: an Online Survey
This observational study will seek to investigate the following questions in women with lipoedema:
- pain characteristics, intensity and patterns of pain
- the relationships between the characteristics, intensity and patterns of pain and age, ethnicity, location, employment status, levels of anxiety/depression, walking ability, ability to work, relations with other people, impact on sleep and quality of life.
- the impact of pain treatments or medications on the intensity of pain. The information will be collected via an online survey and participants will be recruited through social media platforms.
Study Overview
Status
Conditions
Detailed Description
Lipoedema is a chronic adipose tissue disorder that occurs almost exclusively in women and affects approximately 11% worldwide. Pain is a recurring feature described by people with lipoedema (pwL) with a recent study reporting 88.3% of patients indicating pain as a clinical feature. It has been suggested, with chronic long-term conditions, that the pain people experience can be moulded by a myriad of elements.This includes biomedical, psychosocial (e.g. patients' beliefs, expectations, and mood), and behavioural factors (e.g. context, responses by significant others). PwL often experience significant impairment in their daily activities and quality of life. It has further been found that psychological and the biomedical consequences of lipoedema can increase the chances of anxiety and depression which can subsequently further impact on quality of life and pain experience.
This observational study will seek to investigate the following questions in women with lipoedema:
- pain characteristics, intensity and patterns of pain
- the relationships between the characteristics, intensity and patterns of pain and age, ethnicity, location, employment status, levels of anxiety/depression, walking ability, ability to work, relations with other people, impact on sleep and quality of life.
- the impact of pain treatments or medications on the intensity of pain. INformation about pain characteristics, demographics, mood, functional ability and quality of life will be collected via an online survey and participants will be recruited through social media platforms.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Chee Wee Tan, PhD
- Phone Number: +44 (0)141 331 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: +44 (0)141 331 8038
- Email: cheeweetan.uk@gcu.ac.uk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Women with lipoedema
- 16 years and older
Exclusion Criteria:
- Inability to provide consent
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Women with Lipoedema
No interventions administered.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brief Pain Inventory - short form
Time Frame: Only once at participation, the study duration is approximately 2 years
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The Brief Pain Inventory - Short Form is a simple, 9 question self-reporting tool that expands on other questionnaires such as the McGill pain questionnaire which focuses more on the quality of pain.
The questionnaire allows the individual to rate the severity of pain and it also looks at how pain affects daily functions and discloses the site of pain in the past 24 hours.
Within the questionnaire there are four severity questions looking at pain 'at least', 'at worst' (both in the last 24 hours), 'on average' and 'now' using a Likert scale with 0 = no pain to 10 = pain as bad as you can imagine.
Seven pain interference domains are also included in the questionnaire covering general activity, mood, walking ability, normal work, relations with others, sleep and enjoyment of life.
These are also measured on a Likert scale with 0 = no interference to 10 = interferes completely.
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Only once at participation, the study duration is approximately 2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptoms severity scale
Time Frame: During study, only once at participation - 2 years
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Symptom severity will be recorded using a 5 - point Likert scale with 1 = no problem to 5 = extremely severe. These symptoms include:
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During study, only once at participation - 2 years
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Depression, Anxiety and Stress Scale - 21
Time Frame: Only once at participation, the study duration is approximately 2 years
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The Depression, Anxiety and Stress Scale - 21 is a a self-reporting questionnaire with three scales measuring three negative emotional states: depression, anxiety, and stress.
Within the questionnaire, each of the three scales contain 7 items with the scores of these items totalled.
Each item is score on a likert scale of 0 to 3: 0 being ' did not apply to me at all', 1 being 'applied to me to some degree, or some of the time, 2 being 'applied to me to a considerable degree' or a good part of the time', 3 being 'applied to me very much or most of the time'.
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Only once at participation, the study duration is approximately 2 years
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World Health Organization Quality of Life Assessment
Time Frame: Only once at participation, the study duration is approximately 2 years
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The World Health Organization Quality of Life Assessment is a shorter version of the initially developed questionnaire with 100 items, with this shorter version containing 26 items.
It measures the broad domains of physical health, psychological health, social relationships, and environment.
For each of these domains a mean score is produced for use within research and analysis.
The items are rated on a 5-point Likert scale (low score of 1to high score of 5) to determine the raw item score.
The the mean for each domain is calculated.
After which, the domain score is multiplied by 45 to transform the domain score into a scaled score.
A high score indicates a higher quality of life.
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Only once at participation, the study duration is approximately 2 years
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Demographic questionnaire
Time Frame: Only once at participation, the study duration is approximately 2 years
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Data for the following variables will be collected from the participants:
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Only once at participation, the study duration is approximately 2 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chee Wee Tan, PhD, Glasgow Caledonian University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EC2_CWT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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