LipedemaNCT05114317
Characteristics of Pain in Women With Lipoedema
An observational study of Lipedema, run by Glasgow Caledonian University at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Lipedema
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2020to 30 Apr 2022
- 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
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women with lipoedema.
Who may be able to join
- Women with lipoedema
- 16 years and older
Who cannot join
- Inability to provide consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Glasgow Caledonian University
Glasgow
Chee Wee Tan, PhD, +44 (0)141 331 8038, cheeweetan.uk@gcu.ac.uk
About this study
Official title: 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.
Read the 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.
- Conditions
- Lipedema
- Keywords
- Pain, Emotional status, Quality of life
- Medical subject headings
- Lipedema, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women with Lipoedema | No interventions administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Only once at participation, the study duration is approximately 2 years
Secondary outcomes (3)
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.
Measured: During study, only once at participation - 2 years
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'.
Measured: Only once at participation, the study duration is approximately 2 years
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.
Measured: Only once at participation, the study duration is approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start1 Apr 2020
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glasgow Caledonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chee Wee Tan, PhD, Principal investigator, Glasgow Caledonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05114317
- Sponsor's protocol ID
- EC2_CWT
- Status last verified
- Nov 2021
- First submitted
- 2 Jun 2021
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Characteristics, Intensity, Patterns, Impact and Quality of Life in Women With Lipoedema: an Online Survey
- ClinicalTrials.gov ID
- NCT05114317
- Acronym / sponsor ID
- EC2_CWT
- Conditions
- Lipedema
- Keywords
- Pain, Emotional status, Quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Glasgow Caledonian UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 9 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with Lipoedema | – | –No interventions administered. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women with lipoedema.
Key inclusion criteria (2 listed)
- Women with lipoedema
- 16 years and older
Key exclusion criteria (1 listed)
- Inability to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Brief Pain Inventory - short form
Time frame: Only once at participation, the study duration is approximately 2 years
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.
3 secondary outcomes
Symptoms severity scale
Time frame: During study, only once at participation - 2 years
Depression, Anxiety and Stress Scale - 21
Time frame: Only once at participation, the study duration is approximately 2 years
World Health Organization Quality of Life Assessment
Time frame: Only once at participation, the study duration is approximately 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chee Wee Tan, PhD principal investigator
Glasgow Caledonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lipedema, 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 9 Nov 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 (+44 (0)141 331 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?
Brief Pain Inventory - short form (time frame: Only once at participation, the study duration is approximately 2 years). 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 9 Nov 2021.