transcutaneous electrical nerve stimulation in diabetic neuropathy sanjay kalra, bharti kalra,...

TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION IN

DIABETIC NEUROPATHY

Sanjay Kalra, Bharti Kalra,

Bharti Hospital, Karnal

INDIA

bhartihospital@rediffmail.com

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

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.

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).

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).

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.

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.

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)

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)

TENS PARAMETERS

• WAVE FORMS

Biphasic (containing both + ve and –ve waveforms).

may be –

Square

Rectangular

Sinusoidal

Triangular /spiked

Selection depends on patient’s comfort.

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)

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)

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.

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

Group Oxcarbamazepine +

Sham electrodes

TENS

Age (years) 47.60 ± 22.40 46.11 ± 23.88

Gender (male/female) 79/46 112/68

Duration of diabetes (years)

6.04 ± 1.11 6.12 ± 0.64

Durn of neuropathy (years)

1.86 ± 1.12 1.86 ± 1.21

HbA1c (%) 8.48 ± 0.63 8.62 ± 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

BASELINE CHARACTERISTICS

Symptom Oxcarbamazepine TENS

Tingling 60/125 (48.00%) 84/180 (46.66%)

Burning30/125 (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%)

Allodynia3/125 (2.40%)

11/180 (6.11%)

Lancinating3/125 (2.40%) 3/180 (1.66%)

0.00%

5.00%

10.00%

15.00%

20.00%

25.00%

30.00%

35.00%

40.00%

45.00%

50.00%

IST GROUP

IIND GROUP

TINGLING BURNING PAIN RESTLESS ALLODYNIA LANCINATING LEGS

EXTENT OF NEUROPATHY: TENS GROUP

Symptom below ankle ankle mid calf knee thigh

burning 41 26 14 1 2

tingling/ants crawling

10 13 10 9 0

lancinating 14 5 8 1 1

deep pain 0 0 10 0 1

restless legs 0 2 1 8 0

allodynia 1 2 0 0 0

Total 66 48 43 19 4

0

5

10

15

20

25

30

35

40

45

B T L DP RL AL

belowankle

ankle

mid calf

knee

thigh

Symptom TENS GROUP

mean improvement

(pain score)

OXCARB GROUP

mean improvement

(pain score)

burning*** 3.28 ± 0.64 1.12 ± 0.33

tingling/ ants crawling* 2.62 ± 0.35 1.68 ± 0.72

lancinating*** 3.12 ± 0.64 1.01 ± 0.63

deep pain*** 3.00 ± 0.00 2.00 ± 0.15

restless legs* 2.16 ± 0.56 0.91 ± 0.12

Allodynia* 2.15 ± 0.35 1.51 ± 0.35

5

4

3

2

1

Tingling Burning Pain Restless Allodynia Lancinating Legs

I

II

I***

II

I***

II

I = TENS GROUPII = OXCARBAMAZEPINE GROUP

p < 0.05 for all groupsP < 0.01 for ***

I

II

I

II

I***

II

Gender n male female total

Burning 42 2.46 ± 0.96 3.58 ± 0.24 3.28 ± 0.64

Tingling 84 2.15 ±1.24 2.88 ±1.27 2.62 ± 0.35

Lancinating 3 - 3.12 ± 0.64 3.12 ± 0.64

Deep pain 29 3.00 ± 0.00

3.00 ± 0.00 3.00 ± 0.00

Restless legs

11 - 2.16 ± 0.56 2.16 ± 0.56

Allodynia 11 2.00 ± 0.00 2.31 ± 0.31 2.15 ± 0.35

TENS GROUP: PAIN SCORE IMPROVEMENT

0

0.5

1

1.5

2

2.5

3

3.5

4

MALE

FEMALE

BURNING TINGLING LANCINATING DEEP PAIN RESTLESS ALLODYNIA

Age n <40 y 41-60 y >60 y total

Burning 42 4.00 ± 0.00 3.12 ± 0.64 2.86 ± 1.24 3.28 ± 0.64

Tingling 84 3.12 ± 0.96 2.75 ± 0.62 2.00 ± 0.00 2.62 ± 0.35

Lancinating 3 3.12 ± 0.64 -- -- 3.12 ± 0.64

Deep pain 29 3.00 ± 0.00 3.00 ± 0.00 3.00 ± 0.00 3.00 ± 0.00

Restless legs

11 2.16 ± 0.56 -- -- 2.16 ± 0.56

allodynia 11 2.00 ± 0.00 2.31 ± 0.20 2.31 ± 0.20 2.15 ± 0.35

TENS GROUP: PAIN SCORE IMPROVEMENT

0

0.5

1

1.5

2

2.5

3

3.5

4

<40 y

41-60 y

>60 y

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

TENS GROUP/OXCARBAMAZEPINE GROUP

Symptom Oxcarb group Mean improvement

(VPT)

TENS group Mean

improvement (VPT)

Burning* 5.66 ± 1.50 9.00 ± 4.00

Tingling* 3.80 ± 1.09 7.83 ± 2.40

Lancinating* 3.80 ± 1.09 7.50 ± 2.73

Deep pain* 1.60 ± 0.89 4.00 ± 1.00

Restless legs* 2.50 ± 2.88 8.33 ± 2.88

Allodynia* 0.33 ± 0.57 4.66 ± 0.57

* = p<0.05

• 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

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

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.

ACKNOWLEDGEMENTS

STAFF AND PATIENTSof

BHARTI HOSPITALKARNAL

MEMBERS of

THE PEER GROUP INDIA

Thank you