Clinical trial NCT05114317: Characteristics of Pain in Women With Lipoedema
Official title: Pain Characteristics, Intensity, Patterns, Impact and Quality of Life in Women With Lipoedema: an Online Survey
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lipedema
Keywords: Pain
Emotional status
Quality of life
Lead sponsor: Glasgow Caledonian University
Sponsor class: OTHER
First posted: 2021-11-09
Enrollment: 200
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with lipoedema.

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

* Women with lipoedema
* 16 years and older

Exclusion Criteria:

- Inability to provide consent

Primary outcomes:
measure: Brief Pain Inventory - short form
timeFrame: Only once at participation, the study duration is approximately 2 years
Secondary outcomes:
measure: Symptoms severity scale
timeFrame: During study, only once at participation - 2 years
measure: Depression, Anxiety and Stress Scale - 21
timeFrame: Only once at participation, the study duration is approximately 2 years
measure: World Health Organization Quality of Life Assessment
timeFrame: Only once at participation, the study duration is approximately 2 years
Other outcomes:
measure: Demographic questionnaire
timeFrame: Only once at participation, the study duration is approximately 2 years
Locations:
city: Glasgow
country: United Kingdom
facility: Glasgow Caledonian University
Study officials:
affiliation: Glasgow Caledonian University
name: Chee Wee Tan, PhD
role: PRINCIPAL_INVESTIGATOR
References: