Characteristics of Pain in Women With Lipoedema

NCT05114317 | Unknown

• 1 other identifier: EC2_CWT
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Lipedema

Keywords

Pain; Emotional status; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Symptoms severity scale

  During study, only once at participation - 2 years

• Depression, Anxiety and Stress Scale - 21

  Only once at participation, the study duration is approximately 2 years

• World Health Organization Quality of Life Assessment

  Only once at participation, the study duration is approximately 2 years

Other Outcomes (1)

• Demographic questionnaire

  Only once at participation, the study duration is approximately 2 years

Study Arms (1)

Women with Lipoedema

No interventions administered.

Eligibility Criteria

• Age: 16 Years+
• Gender Eligibility Details: Participant eligibility is based on self-representation of gender identity.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with lipoedema.

You may qualify if:

• Women with lipoedema
• years and older

You may not qualify if:

• \- Inability to provide consent

Sponsors & Collaborators

• Glasgow Caledonian University: lead

Study Sites (1)

Glasgow Caledonian University

Glasgow, United Kingdom

RECRUITING

MeSH Terms

Conditions

Lipedema; Pain

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chee Wee Tan, PhD

  Glasgow Caledonian University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chee Wee Tan, PhD

CONTACT

+44 (0)141 331 8038; cheeweetan.uk@gcu.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: November 9, 2021
• Study Start: April 1, 2020
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: November 9, 2021

Record last verified: 2021-11

Locations

GB (1)