1. TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION IN DIABETIC NEUROPATHY Sanjay Kalra, Bharti Kalra, Bharti Hospital, Karnal INDIA bhartihospital@rediffmail.com

2. The first uses of electroanalgesia were recorded by Aristotle, Pliny and Plutarch, who reported application of electrical fish to pain sites.

4. BACKGROUND Neuropathy is a common complication of diabetes. Painful neuropathy (PN) is a significant cause of morbidity in diabetes. Many drugs are available to manage PN, but all have limited success. There is a need for non pharmacological means of symptom management.

5. TENS  Transcutaneous electrical nerve stimulation (TENS) is an electrical modality of pain relief (Chabel et al; 1997, Shealy 2003).  Considered gold standard amongst non pharmacological modalities of pain relief (Mc Quay et al;1997).

6. PRESENT STATUS  Few reports are available, however, on the use of TENS in diabetic painful neuropathy (Kumar et al 1997, 98, Alvarez et al 1999).  No reports are available on effect of TENS on varying symptoms such as burning, lancinating pain, deep pain, crawling sensation and allodynia.  No reports are available on effect of TENS on VPT (vibratory perception threshold).

7. TENS  TENS devices consist of electronic stimulus generator which transmits pulses to electrodes on skin for pain management.  Electrical pulses may block transmission of pain fibres ( large diameter myelinated A  vs non myelinated slow C fibres) or may stimulate release of endogenous opioids.

9. STUDY DESIGN  Single blind, randomized, prospective, single centre study at Bharti Hospital, Karnal.  To assess efficacy of TENS, compared with oxcarbamazepine, in painful neuropathy in patients of type 2 diabetes mellitus.  To assess efficacy of TENS in different symptoms of pain.  To assess efficacy of TENS in improving vibration perception threshold (VPT) in patients of diabetic neuropathy.

10. PATIENT POPULATION  125 patients in group I oxcarbamazepine 300 mg b d x 3 weeks. Five o d/ EOD sittings of 15 min using sham electrodes with no stimulation.  180 patients in group II 5 o d/ EOD sittings of TENS.( Life Care, Ghaziabad, India)  Duration, intensity of TENS decided on daily basis by physiotherapist (current modulation; hold: relax ratio modulation)

11. STUDY DESIGN  Glycemic control: Insulin/OHA  No opioids, TCAs, SSRIs etc. given to TENS group.  Supportive management as needed.  Pain severity assessed by visual analog scale 0 - 10.  Glycemic control assessed by weekly FBG, baseline HbA1c.  VPT assessed by biothesiometry ( Dhansai Labs, India)

13. TENS PARAMETERS WAVE FORMS Biphasic (containing both + ve and –ve waveforms). may be –  Square  Rectangular  Sinusoidal  Triangular /spiked Selection depends on patient’s comfort.

14. TENS PARAMETERS FREQUENCY OF DOSING EOD to q6h (od or EOD) DURATION OF SITTING 15 mins to 1 hour (15 mins) FREQUENCY 80-150 Hz (150 Hz) PULSE WIDTH / DURATION 50 -400 µs (100-200 µs)

15. TENS PARAMETERS CURRENT 0 – 60 mA ; treatment based on patients sensation (12 – 30 mA). CONSTANT CURRENT VS VOLTAGE constant voltage. HOLD TIME 10:1 to 1:1 ratio (6” hold 4” rest ratio)

16. TENS PARAMETERS PLACEMENT OF ELECTRODES  Associated nerve roots and dermatomes.  Point of pain  Acupuncture point proximal/distal to point of pain.  Trans artheral placements ( knee & foot).  Contra lateral placements in inaccessible areas due to amputations, dressings, open wounds & casts.

19. MODULATION IN TENS  Frequency modulation Pulse width modulation  Current modulation May vary about 10% periodically. (e.g 12 to 15 to 12 to 15 mA etc.) Hold: relax ratio modulation

21. GroupOxcarbamazepine + Sham electrodes TENS Age (years)47.60 ± 22.4046.11 ± 23.88 Gender (male/female)79/46112/68 Duration of diabetes (years) 6.04 ± 1.116.12 ± 0.64 Durn of neuropathy (years) 1.86 ± 1.121.86 ± 1.21 HbA1c (%)8.48 ± 0.638.62 ± 0.91 bl glucose fasting baseline 3 weeks 148.1 ± 48.2 mg% 112.2 ± 21.9 mg % 161.6 ± 48.3 mg % 109.5 ± 23.5 mg% BASELINE CHARACTERISTICS

22. Symptom Oxcarbamazepine TENS Tingling 60/125 (48.00%)84/180 (46.66%) Burning 30/125 (24.00%) 42/180 (23.33%) Deep pain 18/125 ( 14.40%) 29/180 (16.11%) Restless legs 11/125 (8.80%) 11/180(7.22%) Allodynia 3/125 (2.40%) 11/180 (6.11%) Lancinating 3/125 (2.40%)3/180 (1.66%)

23. TINGLING BURNING PAIN RESTLESS ALLODYNIA LANCINATING LEGS

24. EXTENT OF NEUROPATHY: TENS GROUP Symptombelow ankleanklemid calfkneethigh burning 41 261412 tingling/ ants crawling 101310 9 0 lancinating 145 8 11 deep pain 001001 restless legs 021 8 0 allodynia 12000 Total 664843194

26. Symptom TENS GROUP mean improvement (pain score) OXCARB GROUP mean improvement (pain score) burning***3.28 ± 0.641.12 ± 0.33 tingling/ ants crawling*2.62 ± 0.351.68 ± 0.72 lancinating***3.12 ± 0.641.01 ± 0.63 deep pain***3.00 ± 0.002.00 ± 0.15 restless legs*2.16 ± 0.560.91 ± 0.12 Allodynia* 2.15 ± 0.35 1.51 ± 0.35

27. 5432154321 Tingling Burning Pain Restless Allodynia Lancinating Legs I II I*** II I*** II I = TENS GROUP II = OXCARBAMAZEPINE GROUP p < 0.05 for all groups P < 0.01 for *** I II I I*** II

28. Gender nmalefemaletotal Burning 422.46 ± 0.963.58 ± 0.243.28 ± 0.64 Tingling 842.15 ±1.242.88 ±1.272.62 ± 0.35 Lancinating3-3.12 ± 0.64 Deep pain 293.00 ± 0.00 3.00 ± 0.00 Restless legs 11-2.16 ± 0.56 Allodynia 112.00 ± 0.002.31 ± 0.31 2.15 ± 0.35 TENS GROUP: PAIN SCORE IMPROVEMENT

29. BURNING TINGLING LANCINATING DEEP PAIN RESTLESS ALLODYNIA

30. Agen<40 y41-60 y>60 ytotal Burning424.00 ± 0.003.12 ± 0.642.86 ± 1.243.28 ± 0.64 Tingling843.12 ± 0.962.75 ± 0.622.00 ± 0.002.62 ± 0.35 Lancinating33.12 ± 0.64 -- 3.12 ± 0.64 Deep pain293.00 ± 0.00 Restless legs 112.16 ± 0.56-- 2.16 ± 0.56 allodynia112.00 ± 0.002.31 ± 0.20 2.15 ± 0.35 TENS GROUP: PAIN SCORE IMPROVEMENT

31. BURNING TINGLING LANCINA- DEEP REST- ALLODYNIA TING PAIN LESS LEGS

32. TENS GROUP/OXCARBAMAZEPINE GROUP SymptomOxcarb group Mean improvement (VPT) TENS group Mean improvement (VPT) Burning*5.66 ± 1.509.00 ± 4.00 Tingling*3.80 ± 1.097.83 ± 2.40 Lancinating*3.80 ± 1.097.50 ± 2.73 Deep pain* 1.60 ± 0.89 4.00 ± 1.00 Restless legs*2.50 ± 2.888.33 ± 2.88 Allodynia*0.33 ± 0.574.66 ± 0.57 * = p<0.05

33. Change in pain score: No correlation with extent of neuropathy No correlation with HbA1c Change in VPT: No difference in gender groups No difference in age groups No correlation with extent of neuropathy No correlation with HbA1c TENS GROUP :VPT IMPROVEMENT

34. DISCUSSION  Till date no study has tried to assess effect of TENS in different symptoms of neuropathy and its effects on improving VPT.  This study demonstrates the increased efficacy of TENS in diabetic neuropathy with predominant sensory symptoms and altered VPT

35. CONCLUSION  TENS is more effective in  young patients  women  lancinating pain, burning pain, deep pain  The efficacy and efficiency of TENS as a therapeutic modality in diabetes with painful neuropathy is worthy of more extensive study.

36. ACKNOWLEDGEMENTS STAFF AND PATIENTS of BHARTI HOSPITAL KARNAL MEMBERS of THE PEER GROUP INDIA

37. Thank you