Lipedema Clinical Trial
Official title:
Evaluation of Neuropathic Pain in Lipedema
NCT number | NCT05329324 |
Other study ID # | IzellipodemTez |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 20, 2022 |
Est. completion date | June 1, 2023 |
Lipedema is a chronic progressive disease characterized by abnormal increase of subcutaneous adipose tissue. It is characterized by bilateral enlargement of the lower and/or upper extremities, typically sparing the hands and feet. This disease, which almost always affects women, has rarely been described in men due to hormonal disorders or concomitant diseases such as cirrhosis. Although the results vary, it has been reported that it is seen at a minimum rate of 1:72.000 or 11% of women are affected by this disease. Although it is a common disease, it can often be missed in daily practice. Therefore, it is very important to define the disease clinic well. Lipedema usually presents with swelling in the bilateral extremities. It begins in the post-adolescent period and is progressive. It does not respond to diet and exercise, does not improve with elevation, is spontaneous or painful to touch. Patients describe easy bruising with touch or minor trauma. In early lipedema, pain may be the main complaint in the extremities before the development of skin findings. Because of the absence of a defined clear pain pattern in these patients, diagnosis can be missed and confused with other diseases. In addition, it causes limitations in treatment of the pain. Adipose tissue can cause nociceptive and neuropathic pain because it contains both nociceptive neurons and neural innervation. It isn't known whether lipedema pain is of nociceptive or neuropathic origin. In different studies, the pain pattern is defined in different ways such as hyperalgesia, allodynia, spontaneous pain, blunt, heaviness, pressure, tearing, stabbing, severe and unbearable. In this study, the investigators aim to determine if the pain characteristics of patients with lipedema is neuropathic or not and to define the pain characteristics better in order to ensure earlier recognition and treatment of pain.
Status | Recruiting |
Enrollment | 84 |
Est. completion date | June 1, 2023 |
Est. primary completion date | June 1, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Ages between 18-65 - Diagnosed with lipoedema - Those who agreed to participate in the study - To be at the appropriate sociocultural level to participate in the study - For the control group, the patient has a diagnosis of acute subacromial impingement syndrome Exclusion Criteria: - Having type 1 or type 2 diabetes - Patients with uncontrolled thyroid dysfunction - Patients with chronic venous insufficiency and/or lymphedema - Patients with acute or chronic renal failure - Heart failure - Having cancer or continuing cancer treatment - Diagnosed with polyneuropathy - Those with radiculopathy - Patients with advanced degenerative joint disease in the affected extremity - Those who have received antiepileptic, antidepressant medication in the last 6 months - Persons with visual and hearing impairments that impair adaptation to work - Patients who are illiterate and have cognitive impairment that will prevent them from giving written consent will not be included in the study. |
Country | Name | City | State |
---|---|---|---|
Turkey | Dokuz Eylul Hospital | Izmir |
Lead Sponsor | Collaborator |
---|---|
Dokuz Eylul University |
Turkey,
Akçali Y, Atabey R. Lipödem ve Lipolenfödem: Tani ve Tedavi, Türkiye Klinikleri J Cardiovasc Surg-Special Topics. 2018; 10:56-72
Aksoy H, Karadag AS, Wollina U. Cause and management of lipedema-associated pain. Dermatol Ther. 2021 Jan;34(1):e14364. doi: 10.1111/dth.14364. Epub 2020 Oct 12. Review. — View Citation
Alkan H, Ardic F, Erdogan C, Sahin F, Sarsan A, Findikoglu G. Turkish version of the painDETECT questionnaire in the assessment of neuropathic pain: a validity and reliability study. Pain Med. 2013 Dec;14(12):1933-43. doi: 10.1111/pme.12222. Epub 2013 Aug 7. — View Citation
Angst F, Benz T, Lehmann S, Sandor P, Wagner S. Common and Contrasting Characteristics of the Chronic Soft-Tissue Pain Conditions Fibromyalgia and Lipedema. J Pain Res. 2021 Sep 17;14:2931-2941. doi: 10.2147/JPR.S315736. eCollection 2021. — View Citation
Ayhan FF. Lipödem: Klinik Tani, Evreleme, Tiplendirme, Degerlendirme ve Tani Kriterleri.Tanidan Tedaviye Lipödem Saglik Profesyonelleri Için Rehber Kitap. Borman P, Dalyan M, Figen Ayhan FF eds. Hipokrat Kitabevi, Ankara 2019:17-34
Child AH, Gordon KD, Sharpe P, Brice G, Ostergaard P, Jeffery S, Mortimer PS. Lipedema: an inherited condition. Am J Med Genet A. 2010 Apr;152A(4):970-6. doi: 10.1002/ajmg.a.33313. — View Citation
Herbst KL, Mirkovskaya L, Bharhagava A, Chava Y, T. Te CH. Lipedema Fat and Signs and Symptoms of Illness, Increase with Advencing Stage, Archives of Medicine. 2015; 7:1-8
Kücükdeveci AA, McKenna SP, Kutlay S, Gürsel Y, Whalley D, Arasil T. The development and psychometric assessment of the Turkish version of the Nottingham Health Profile. Int J Rehabil Res. 2000 Mar;23(1):31-8. — View Citation
Ömer A, Güvenir T, Küey, L, Kültür S. Hastane Anksiyete ve Depresyon Ölçegi Türkçe Formunun Geçerlilik ve Güvenilirlik Çalismasi. Türk Psikiyatri Dergisi. 1997; 8: 280- 287.
Shavit E, Wollina U, Alavi A. Lipoedema is not lymphoedema: A review of current literature. Int Wound J. 2018 Dec;15(6):921-928. doi: 10.1111/iwj.12949. Epub 2018 Jun 29. Review. — View Citation
Szél E, Kemény L, Groma G, Szolnoky G. Pathophysiological dilemmas of lipedema. Med Hypotheses. 2014 Nov;83(5):599-606. doi: 10.1016/j.mehy.2014.08.011. Epub 2014 Aug 23. Review. — View Citation
Torre YS, Wadeea R, Rosas V, Herbst KL. Lipedema: friend and foe. Horm Mol Biol Clin Investig. 2018 Mar 9;33(1). doi: 10.1515/hmbci-2017-0076. Review. — View Citation
WOLD LE, HINES EA Jr, ALLEN EV. Lipedema of the legs; a syndrome characterized by fat legs and edema. Ann Intern Med. 1951 May;34(5):1243-50. — View Citation
Yucel A, Senocak M, Kocasoy Orhan E, Cimen A, Ertas M. Results of the Leeds assessment of neuropathic symptoms and signs pain scale in Turkey: a validation study. J Pain. 2004 Oct;5(8):427-32. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | LANSS Pain Scale | LANSS Pain Scale is an evaluation form that helps to understand whether the nerves carrying pain signals are working normally, and it consists of two parts, including a pain questionnaire and a sensory evaluation. As a result of the calculation made according to answers, a score above 12 is associated with the presence of neuropathic pain. | Baseline | |
Primary | Pain Detect Questionnaire | Pain Detect Questionnaire consists of questions about characteristics, severity and spread of the pain, and it provides the opportunity to score with 5 options as none, very mild, mild, moderate, severe, very severe. This survey, which consists of 38 points in total; in the presence of above 19 points, the neuropathic pain component is interpreted as possible | Baseline | |
Secondary | Nottingham Health Profile | Nottingham Health Profile consists of 6 sections and a total of 38 questions evaluating patients' pain, emotional reaction, sleep, social isolation, physical activity and energy. In this questionnaire, where the highest score is 600 points, a high score is associated with a deterioration in quality of life | Baseline | |
Secondary | Hospital Anxiety and Depression Scale | Hospital Anxiety and Depression Scale consists of 14 questions about anxiety and depression and 4 options for each question. According to the results, 0-7 points were interpreted as normal, 8-10 points were considered borderline, and 11 points and above were interpreted as abnormal | Baseline |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04492046 -
Complex Decongestive Applications in Patients With Lipedema
|
||
Completed |
NCT04643392 -
Physiotherapy Applications in Upper Extremity Lipedema
|
||
Recruiting |
NCT05464927 -
Visualizing Vascular Mechanisms of Lipedema
|
||
Completed |
NCT02907411 -
Quadrivas Therapy® to Reduce Lipedema Subcutaneous Adipose Tissue (QUADRIVAS)
|
N/A | |
Completed |
NCT06238791 -
Plantar Pressure Analysis and Foot Biomechanics in Lipedema and Chronic Venous Disease
|
||
Completed |
NCT03758651 -
Williams Syndrome Strength, Hormones, Activity & Adiposity, DNA Programming, Eating Study
|
||
Completed |
NCT03710798 -
Effect of an Low Carbon High Fat Diet on Pain- and Quality of Life in Patients With Lipedema
|
N/A | |
Not yet recruiting |
NCT04166084 -
Trunk Stabilization Exercises at Lipoedema Patients
|
N/A | |
Recruiting |
NCT05628948 -
Vascular Lab Resource (VLR) Biorepository
|
||
Not yet recruiting |
NCT05944796 -
Diathermy Effectiveness in Reducing Subcutaneous Adipose Tissue Affected by Lipedema
|
N/A | |
Completed |
NCT05616962 -
Collected Data of Medical Food, Vasculera or Diosmiplex, in Clinic Patients 20 to 70 Years Old Diagnosed With Lipedema
|
N/A | |
Active, not recruiting |
NCT04632810 -
Effect of Ketosis on Pain and Quality of Life in Patients With Lipedema
|
N/A | |
Recruiting |
NCT05284266 -
The National Lipedema Study
|
N/A | |
Active, not recruiting |
NCT06338059 -
Relationship Between Vitamin D and Vitamin B12 Levels and Neuropathic Pain in Lipedema
|
||
Completed |
NCT04076891 -
Treatment of Women With Lipedema Involving Substantial Fat Above the Knee or of Women and Men With Nodular Dercum's Disease
|
Phase 2 | |
Completed |
NCT03492840 -
Treatment of Women With Lipedema Involving Substantial Fat Knee of Women and Men With Nodular Dercum's Disease
|
Phase 2 | |
Recruiting |
NCT02838277 -
Insight Into Subcutaneous Adipose Tissue Disorders
|
N/A | |
Completed |
NCT05966779 -
Physical Therapy in Lipedema Surgery
|
||
Recruiting |
NCT05488977 -
The Effects of Endurance Training on Lipedema
|
N/A | |
Completed |
NCT04213989 -
Intermittent Pneumatic Compression in Women With Lipo-lymphedema (Lipedema With Swelling)
|
N/A |