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Title: EFFICACY OF INDIAN MAKE TRANSCUTANEOUS ELECTRIC NERVE STIMULATION DEVICE IN WOMEN WITH PRIMARY DYSMENORRHOEA- A RANDOMIZED CONTROLLED TRIAL
e-poster Number: EP 468
Category: Sexual and Reproductive Health and Rights and Contraception
Author Name: Dr. Ritu Sharma
Institute: Government Institute of Medical Sciences, Greater Noida, UP
Co-Author Name:
Abstract :
Introduction
Primary dysmenorrhea causes significant disruption in quality of life of women. With limited literature available, there emerges need to evaluate the effectiveness and safety of the Indian make TENS Device as non-pharmaceutical alternative.
Aims & objectives
Primary Objective:
1. To evaluate the effectiveness of the new Indian make TENS device for managing Primary Dysmenorrhoea.
Secondary Objective:
2. To assess the acceptance, adverse reactions of the TENS Device and to compare the quality of life before and after intervention.
Material & methods
In this double-blinded RCT, women aged 14-30 years with primary dysmenorrhoea, and Working ability, Location, Intensity, Days of dysmenorrhea score (WaLIDD score) > 5 were recruited. 120 participants will be randomly allocated to two groups:
1. TENS group: Women were given TENS Device for 2 months
2. Placebo group: Women were given Placebo-device for 2 months
The analyst recorded their menstrual symptoms, classified quality of life based on WHO short survey questionnaire SF-12, the need for analgesics, and individual pain scores using visual analogue scale (VAS 0?10 cm). After two cycles, there was cross-over of the groups followed by collection of same data again after next 2 cycles.
Results
Compared to placebo, TENS was associated with significant reduction in mean pain VAS scores from 6.73 to 4.18 points (P<0.009), and prolonged the duration of pain-relief (P<.01). There was significant reduction in the usage of number of analgesic tablets (P<.01). Although quality of life improved in TENS group, yet QOL and adverse event profiles showed no statistically significant differences among two groups.
Conclusion -
Indigenous Transcutaneous Electric Nerve Stimulation TENS Device is a cost-effective, safe, non-pharmacological option available for primary dysmenorrhea.
