Is The Pain in Lipedema Patients Neuropathic Pain?

NCT05329324 | Completed

• 1 other identifier: İzellipodemTez
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lipedema

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Nottingham Health Profile

  Baseline

• Hospital Anxiety and Depression Scale

  Baseline

Study Arms (2)

Study Group - Lipedema

Questionnaire for study group

Other: Questionnaire for study group

Control Group - Acute Subacromial Impingement

Questionnaire for control group

Other: Questionnaire for control group

Interventions

Questionnaire for study group OTHER

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.

Study Group - Lipedema

Questionnaire for control group OTHER

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.

Control Group - Acute Subacromial Impingement

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylul Hospital

Izmir, 35330, Turkey (Türkiye)

Location

Related Publications (14)

• 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. doi: 10.7326/0003-4819-34-5-1243. No abstract available.

  PMID: 14830102 BACKGROUND

• Akçalı Y, Atabey R. Lipödem ve Lipolenfödem: Tanı ve Tedavi, Türkiye Klinikleri J Cardiovasc Surg-Special Topics. 2018; 10:56-72

  BACKGROUND

• 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

  BACKGROUND

• Torre YS, Wadeea R, Rosas V, Herbst KL. Lipedema: friend and foe. Horm Mol Biol Clin Investig. 2018 Mar 9;33(1):/j/hmbci.2018.33.issue-1/hmbci-2017-0076/hmbci-2017-0076.xml. doi: 10.1515/hmbci-2017-0076.

  PMID: 29522416 BACKGROUND

• 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.

  PMID: 20358611 BACKGROUND

• Szel E, Kemeny 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.

  PMID: 25200646 BACKGROUND

• Ayhan FF. Lipödem: Klinik Tanı, Evreleme, Tiplendirme, Değerlendirme ve Tanı Kriterleri.Tanıdan Tedaviye Lipödem Sağlık Profesyonelleri İçin Rehber Kitap. Borman P, Dalyan M, Figen Ayhan FF eds. Hipokrat Kitabevi, Ankara 2019:17-34

  BACKGROUND

• 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.

  PMID: 33001552 BACKGROUND

• 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.

  PMID: 34557035 BACKGROUND

• 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.

  PMID: 29956468 BACKGROUND

• 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. doi: 10.1016/j.jpain.2004.07.001.

  PMID: 15501424 BACKGROUND

• 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.

  PMID: 23924395 BACKGROUND

• Kucukdeveci AA, McKenna SP, Kutlay S, Gursel 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. doi: 10.1097/00004356-200023010-00004.

  PMID: 10826123 BACKGROUND

• Ömer A, Güvenir T, Küey, L, Kültür S. Hastane Anksiyete ve Depresyon Ölçeği Türkçe Formunun Geçerlilik ve Güvenilirlik Çalışması. Türk Psikiyatri Dergisi. 1997; 8: 280- 287.

  BACKGROUND

MeSH Terms

Conditions

Lipedema

Interventions

Surveys and Questionnaires; Control Groups

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Epidemiologic Research Design; Research Design; Methods

Study Officials

• Ebru sahin, MD

  Dokuz EU

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 15, 2022
• Study Start: April 20, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: August 13, 2024

Record last verified: 2024-08

Locations

TU (1)