Is The Pain in Lipedema Patients Neuropathic Pain?

NCT ID: NCT05329324

Last Updated: 2024-08-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 85 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-20
• Study Completion Date: 2023-06-01

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.

Detailed 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.

Conditions

Lipedema

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Study Group - Lipedema

Questionnaire for study group

Questionnaire for study group

Intervention Type: 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.

Control Group - Acute Subacromial Impingement

Questionnaire for control group

Questionnaire for control group

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dokuz Eylul University

OTHER

Sponsor Role: lead

Responsible Party

Nihan ERDINC GUNDUZ

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ebru sahin, MD

Role: STUDY_DIRECTOR

Dokuz EU

Locations

Dokuz Eylul Hospital

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

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Other Identifiers

İzellipodemTez

Identifier Type: -

Identifier Source: org_study_id