22
Participants
Start Date
January 2, 2019
Primary Completion Date
March 31, 2019
Study Completion Date
July 31, 2019
Primary Relief v 2.0
The test product or device called Primary Relief v 2.0 will be used for the study. The study will be conducted for a period of two to three months with the treatment period of 3 - 4 days i.e single treatment (installation). The additional time taken will be to define the characteristics of the patient population and to recruit appropriate patients. Finally, there will be a data analysis and report writing period. Overall, the study is expected to 3 months. The device will be placed onto the auricle part of the ear for percutaneous electrical nerve stimulation.
Paracetamol
A control group, receiving a standard treatment as follows: primary choice of analgesic was intravenous paracetamol, 1 gram, and if the pain relief was inadequate, diclofenac inj. If pain persisted in spite of these measures, 50 mg tramadol was administered intravenously
RECRUITING
Clinic, Warangal
Lead Sponsor
DyAnsys, Inc.
INDUSTRY