1. TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION IN PAEDIATRIC TYPE 1 DIABETIC PATIENTS WITH PAINFUL 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.

3. BACKGROUND Neuropathy is a common complication of diabetes. Painful neuropathy (PN) is gradually being recognized as a significant cause of morbidity in children with diabetes. (Abad F et al, 2002; Karsidag S et al, 2004; Hamilton J et al,2004) Many drugs are available to manage PN, but all have limited application in paediatric population.

4. BACKGROUND 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).

5. PRESENT STATUS Few reports are available, however, on the use of TENS in diabetic painful neuropathy (Kalra et al 2006, Alvaro M et al, 1999) No reports are available on effect of TENS in paediatric diabetes.

6. PRESENT STATUS 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.

8. STUDY DESIGN Single blind, randomized, prospective, single centre study at Bharti Hospital, Karnal. Children aged 1 month, not explainable by other reasons Rickets was excluded

9. PATIENT POPULATION 15 patients in group I : oxcarbamazepine 150 mg b d x 3 weeks and five o d/ EOD sittings of 15 min using sham electrodes with no stimulation. 15 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)

10. STUDY DESIGN Glycemic control: Insulin 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. Validated questionnaires used to assess health distress, physician communication and disease intrusion.

11. STUDY DESIGN Pain severity assessed by visual analog scale Validated questionnaires used to assess health distress, physician communication and disease intrusion. Administered at baseline and at 4 weeks TENS duration: 5 sittings over 5 or 10 days

12. TENS PARAMETERS WAVE FORMS Biphasic (containing both + ve and –ve waveforms). may be – Square Rectangular Sinusoidal Triangular /spiked Selection depends on patients comfort.

13. 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 /2-10 Hz PULSE WIDTH / DURATION 50 -400 µs (100-200 µs)

16. 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)

17. GroupOxcarbamazepineTENS Age (years)12.60 ± 6.4011.11 ± 6.88 Gender (male/female) 9/612/3 Duration of diabetes (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

18. Symptom TENS GROUPOXCARB GROUP burning23 tingling/ ants crawling 11 lancinating11 deep pain86 restless legs33 Allodynia01

19. CHARACTER OF PAIN B=burning T=tingling L=lancinating DP=deep pain RL=restless legs A=allodynia

20. Results Pain scores reduced significantly in both groups, but much more so in the TENS group (from 4.60 ± 0.54 to 2.40 ± 0.54) than the sham electrodes + oxcarbamazepine group (from 4.40 ± 0.54 to 3.60 ± 0.54). A significant change was seen in health distress and disease intrusion scores in the TENS group

21. IMPROVEMENT IN PAIN SCORES

22. Symptom TENS GROUP improvement (pain score) OXCARB GROUP improvement (pain score) burning2.50 ± 0.701.12 ± 0.33 tingling/ ants crawling 4.00 ± 0.002.00 ± 0.00 lancinating3.00 ± 0.001.00 ± 0.00 deep pain2.00 ± 0.000.00 ± 0.00 restless legs2.50 ± 0.001.00 ± 0.00 Allodynia -1.00 ± 0.00

23. IMPROVEMENT IN PAIN SCORES B=burning T=tingling L=lancinating DP=deep pain RL=restless legs A=allodynia

24. DOSE The dose of TENS used varied from 5.5 to 9.0 Hz on the initial day to 3.5 to 5.5 Hz on the last sitting. The dose varied insignificantly for different symptoms The difference in pain relief was maintained after 4 weeks, even though the TENS sittings had stopped

25. Improvement in Physician communication score : 1.43 ± 1.19 to 3.93 ± 0.86 over one month of therapy in all subjects. Disease intrusion: 2.25 ± 0.63 to 1.08 ± 0.39. Health distress score: 3.20 ± 0.82 to 1.35 ± 0.47

26. INPROVEMENT IN PSYCHOLOGICAL PARAMETERS PCS= Physician communication score, DI= disease intrusion, HDS=health distress score

27. DISCUSSION Till date no study has tried to assess effect of TENS in paediatric type 1 diabetes patients. The efficacy and efficiency of TENS as a therapeutic modality in children with diabetes and painful neuropathy is worthy of more extensive study.

28. Thank you