Evaluating the Impact of Vagus Nerve Stimulation on Diabetic Peripheral Neuropathic Pain - A Randomized, Double-Blinded, Sham-Controlled Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus
- Sponsor
- Saima Abass Tahammal
- Enrollment
- 165
- Locations
- 1
- Primary Endpoint
- Neuropathic pain scores
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of the study is to investigate the effects of non-invasive invasive vagal nerve stimulation on diabetic peripheral neuropathic pain in people with diabetes.
Detailed Description
The study is a randomized, double-blinded, sham-controlled, parallel-group clinical trial, which will include participants with diabetic peripheral neuropathic pain. Participants are randomized to receive either active non-invasive transcutaneous vagal nerve stimulation (tVNS) or inactive sham stimulation. The study will investigate the effects of short-term, high-intensity tVNS treatment on peripheral pain. The primary outcome is subjective patient evaluation of pain symptoms by the use of validated questionnaires.
Investigators
Saima Abass Tahammal
Principal Investigator
Shifa International Hospital
Eligibility Criteria
Inclusion Criteria
- •Patients with Type 2 diabetes mellitus \> 1 year
- •Patients experiencing neuropathic pain
Exclusion Criteria
- •Patients with co-morbidities such as chronic pain from other conditions
- •Patients with serious complications of diabetes such as nephropathy and retinopathy
Outcomes
Primary Outcomes
Neuropathic pain scores
Time Frame: up to 24 weeks
Change in neuropathic pain scores assessed by validated questionnaire
Secondary Outcomes
- Quality of life score(up to 24 weeks)