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Volume 7
Journal of Pain & Relief
ISSN: 2167-0846
Pain Management 2018
October 11-12, 2018
October 11-12, 2018 | Zurich, Switzerland
7
th
International Conference and Exhibition on
Pain Research and Management
Arandomized controlled, single-blind trial to investigate if an electrical current – Non-Interventional
Pulsed Radio Frequency (NI PRF) - could improve neuropathic pain and symptoms in patients with
diabetic peripheral neuropathy
Phyllis Berger
University of the Witwatersrand, South Africa
Background
: The prevalence of peripheral diabetic neuropathy (PDN) in diabetic patients is the most common complication
of diabetes. This is due to a consequence of long established hyperglycaemia that alters the physiology of peripheral nerves and
precipitates a metabolic cascade leading to peripheral nerve injury. Neuropathic pain is pain that arises as a direct consequence
of a lesion or disease affecting the somatosensory system. PDN can be assessed by validated neuropathic pain questionnaires
and in this study the Doleur Neuropathiqe 4 (DN4) Test and the Brief Pain Inventory Shortform (BPI-SF) were selected to
evaluate pain intensity and quality of life. Clinically it has been observed that the neurostimulation device in question, NI
PRF has relieved severe pain and improved nerve conduction in various conditions, including diabetic neuropathy and other
neuropathic pain and symptoms.
Purpose
: This randomized and controlled single blind trial intended to investigate changes in the DN4 Test and the BPI-SF in
patients with DPN after three treatments of the NI PRF electrical current. These changes would be evaluated from baseline, 3
weeks after the last treatment and then followed up one month, three months and six months after the last treatment. Patients
with both type 1 and type 2 diabetes would be included in the trial. The tools assessing these patients will indicate whether
this treatment affects neuropathic pain and symptoms (DN4) and implements improvements in the BPI-SF of: visual analogue
scale (VAS) of worst, least, average and present pain, medication use and percentage improvements, interfers with: general
activities, mood, walking and work ability, relations with other people, sleep and quality of life.
Method
: The patients were randomized into a treatment and non-treatment/placebo group. Each patient was given an
assessment of DN4 to determine if they qualify as having neuropathic pain (NP) with a score of 4 and 4+/10. If the patients
have qualified they then continue with the BPI-SF and treatment and or placebo can then proceed. Treatment or placebo is
provided at the sciatic nerve above the bifurcation at the popliteal fossa for 10mins on each leg. Patients were then given 3
treatments once weekly and then follow up only of the DN4 and BPI-SF is given at 3 weeks, 1 month, 3 and 6 months after
the third/last treatment. Patients are reimbursed for their travelling expenses after each attendance – for treatments or the
assessments only. The data is analysed by an independent statistician (Libhaber E, University of the Witwatersrand). At present
46 patients in both groups have been processed and it is intended to evaluate 80 patients to complete this study.
Preliminary Results
: Presently, patients at baseline are – 46 patients, 23 in the active group (A) and in the 23 in the placebo
group (B). The p values indicate the differences between the active and the placebo groups.
DN4 Test
The DN4 Test indicates a significant change from baseline to:
Post 3rd treatment – p value 0.011 (A = 22, B = 23)
These changes were maintained at:
1month follow-up – p value 0.047 (A = 20, B = 21)
6month follow up – p value 0.013 (A = 16, B = 12)
The VAS scores demonstrated significance at 1month for:
Present pain
p = 0.018
Average pain
p = 0.043
Worst pain
p = 0.002
Phyllis Berger, J Pain Relief 2018, Volume 7
DOI: 10.4172/2167-0846-C1-021