Neuropathic Pain and Type II Diabetic Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorBilecik Seyh Edebali Universitesi
About this trial
Diabetes Mellitus (DM) is a common metabolic disease characterized by hyperglycemia resulting from insufficiency, deficiency or absence of the insulin hormone. Chronic hyperglycemia, secondary metabolic and microvascular changes resulting in diabetic neuropathy are among the most common complications encountered in DM patients.
Diabetic neuropathy is called peripheral, autonomic or spinal depending on the region of involvement. Peripheral involvement is more common than other region involvement and its prevalence in DM patients is observed to be 16-87%. Diabetic peripheral neuropathy (DPN) presents with numbness, tingling, paresthesia, muscle weakness and pain. These symptoms can start from the toes and progress to the leg and even the upper extremities.
In diabetic peripheral neuropathy, pain is seen as burning, electric shock or sharp cold pain, increases at night and affects sleep quality. In these patients, daily living activities such as walking, climbing stairs, and sleeping are negatively affected by progressive DPN and pain, falls are observed, mood disorders are experienced, and the quality of life decreases.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years and older,
Diagnosed with type II diabetes,
Reading and writing,
No physical or psychological communication barriers,
Disqualifiers
Diagnosed with type I diabetes
Trial population
Individuals over the age of 18 diagnosed with Type II diabetes
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Neuropathic pain
Self-Leeds Assessment of Neuropathic Symptoms and Sign (S-LANSS) will be used to assess neuropathic pain types. When the score obtained from this scale consisting of 7 items is \>12, neuropathic pain is diagnosed.
Time frame
15/12/2024-30/07/20252
the pain severity
As the first outcome of the study, the patients' neuropathic pain status and pain intensity will be determined. The following scales will be used for this. VAS-Visual Analog Scale will be used to assess pain. Scoring will be between 0-10.
Time frame
15/12/2024-30/07/2025Secondary outcomes
1
Quality of life will be measured with the Diabetes Quality of Life (DQOL) scale
In the study, the quality of life be measured with the Diabetes Quality of Life (DQOL) scale of life of the patients will be measured with the Diabetes Quality of Life (DQOL) scale. 45 questions will be asked in this scale and the answers will be scored.
Time frame
15/12/2024-30/07/20252
the Self-Care Agency Scale
In addition, the Self-Care Agency of the patients will be evaluated. For this, the Self-Care Agency Scale will be used. This scale consists of 35 items. As the score obtained from the scale increases, the self-care agency increases.
Time frame
15/12/2024-30/07/2025Sponsors and contacts
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Source ClinicalTrials.gov