Lipedema Clinical Trial
Official title:
Pain Characteristics, Intensity, Patterns, Impact and Quality of Life in Women With Lipoedema: an Online Survey
NCT number | NCT05114317 |
Other study ID # | EC2_CWT |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 1, 2020 |
Est. completion date | April 30, 2022 |
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | April 30, 2022 |
Est. primary completion date | April 30, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 16 Years and older |
Eligibility | Inclusion Criteria: - Women with lipoedema - 16 years and older Exclusion Criteria: - Inability to provide consent |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Glasgow Caledonian University | Glasgow |
Lead Sponsor | Collaborator |
---|---|
Glasgow Caledonian University |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Demographic questionnaire | Data for the following variables will be collected from the participants:
age ethnicity country of domicile employment status height weight number of comorbidities walking aid usage time of awareness of lipoedema type of lipoedema |
Only once at participation, the study duration is approximately 2 years | |
Primary | Brief Pain Inventory - short form | 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. | Only once at participation, the study duration is approximately 2 years | |
Secondary | Symptoms severity scale | Symptom severity will be recorded using a 5 - point Likert scale with 1 = no problem to 5 = extremely severe. These symptoms include:
swelling of the affected areas, loose connective tissues around the knee joints, tenderness, easy or spontaneous bruising, and presence of spider veins. |
During study, only once at participation - 2 years | |
Secondary | Depression, Anxiety and Stress Scale - 21 | 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'. | Only once at participation, the study duration is approximately 2 years | |
Secondary | World Health Organization Quality of Life Assessment | 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. | Only once at participation, the study duration is approximately 2 years |
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