Is The Pain in Lipedema Patients Neuropathic Pain?

Lipedema Clinical Trial

Official title:

Evaluation of Neuropathic Pain in Lipedema

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05329324
• Other study ID #: IzellipodemTez
• Status: Recruiting
• Start date: April 20, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: July 2022
• Source: Dokuz Eylul University
• Contact: izel topaloglu, MD
• Phone: +905413558735
• Email: ustunkolizel[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

This study is a descriptive cross-sectional study. 42 patients will be included to study who apply to the outpatient clinic of Dokuz Eylul University Faculty of Medicine, Department of Physical Therapy and Rehabilitation, and who are diagnosed or followed up with the diagnosis of lipoedema, aged between 18- 65 years. For the control group, 42 patients who had shoulder pain for less than 3 months and is diagnosed with acute subacromial impingement will be included as the nociceptive pain model. The LANSS Pain Scale and Pain Detect Questionnaire to assess patients' pain characteristics, the Nottingham Health Profile to assess quality of life, and the Hospital Anxiety and Depression Scale to detect the presence of depression and anxiety will be completed by patients. 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. 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. 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. 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. According to results of questionnaires, the datas will be compared with statistical analysis. As a result, the investigators aim to say that lipedema pain is or is not a neurpathic pain.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Lipedema
• Neuralgia

Intervention

Other:
• Questionnaire for study group
Demographic features, Stage and Type, The LANSS Pain Scale and Pain Detect Questionnaire to assess patients' pain characteristics,the Nottingham Health Profile to assess quality of life, and the Hospital Anxiety and Depression Scale to detect the presence of depression and anxiety will be completed by patients.
• Questionnaire for control group
Demographic features, The LANSS Pain Scale and Pain Detect Questionnaire to assess patients' pain characteristics,the Nottingham Health Profile to assess quality of life, and the Hospital Anxiety and Depression Scale to detect the presence of depression and anxiety will be completed by patients.

Locations

Country	Name	City	State
Turkey	Dokuz Eylul Hospital	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

References & Publications (14)

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

Outcome

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