Diabetic Neuropathic Pain. Diabetic polyneuropathy is a type of neuropathy that results from chronic diabetes, causing damage to the peripheral nerves. It often affects the feet and legs, but can also impact other body areas.
Conditions
Interventions
Intervention 1: Intervention group: Intervention Group 1 (Pregabalin):In this group, patients will receive pregabalin at a dose of 75 to 300 mg daily. The medication will be taken orally, divided into
Sponsors
Rasht University of Medical Sciences
Eligibility
Sex/Gender
All
Age
30 Years to 70 Years
Inclusion criteria
Inclusion criteria: Age between 30 and 70 years Diagnosis of type 2 diabetes with a history of at least 5 years Presence of diabetic neuropathic pain with a pain score = 4 based on the BPI-P questionnaire Positive score on the MNSI questionnaire and confirmation of peripheral neuropathy No use of pregabalin, nortriptyline, or duloxetine within the last 4 weeks Ability to understand and complete the study questionnaires Willingness to participate in the study and signing the informed consent Ability to swallow oral medications Not pregnant or breastfeeding for female participants
Exclusion criteria
Exclusion criteria: History of allergy to pregabalin, nortriptyline, or duloxetine Diagnosis of severe psychiatric disorders (e.g., uncontrolled major depression or schizophrenia) Severe hepatic or renal insufficiency Presence of non-diabetic neuropathy (e.g., neuropathy due to alcohol use or other diseases) Pregnancy or breastfeeding Use of medications affecting neuropathic pain within the past month Inability to swallow oral medications Inability to complete the study questionnaires
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diabetic Neuropathic Pain The primary outcome variable in this study is the intensity of diabetic neuropathic pain, which will be measured using the BPI-P (Brief Pain Inventory - Short Form) questionnaire. This questionnaire specifically assesses the level of pain and its impact on patients' quality of life. Pain intensity is measured on a scale of 0 to 10, where 0 indicates no pain and 10 represents the worst pain possible. Timepoint: Diabetic Neuropathic Pain IntensityThe time points for measuring diabetic neuropathic pain intensity in this study are as follows: Baseline (before the intervention begins)Weeks 2, 4, 6, and 8 after the intervention startsAt these time points, pain intensity will be measured using the BPI-P (Brief Pain Inventory - Short Form) questionnaire. Method of measurement: Diabetic Neuropathic Pain IntensityTo measure diabetic neuropathic pain intensity, the BPI-P (Brief Pain Inventory - Short Form) questionnaire will be used. This questionnaire consists of 4 questions to assess pain intensity at 4 different time points. Patients will rate their pain intensity on a scale of 0 to 10, where 0 indicates no pain and 10 indicates the worst pain possible. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactCyrus Emir Alavi
Rasht University of Medical Sciences
Outcome results
None listed