Transcutaneous Electric Nerve Stimulation for Analgesia During Outpatient Endometrial Biopsy: A Randomized Controlled Trial

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Active transcutaneous electric nerve stimulation (TENS) was associated with statistically lower post-biopsy pain and higher satisfaction compared to placebo TENS, though a clinical difference was not observed.

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This randomized, double-blind trial evaluated whether transcutaneous electric nerve stimulation reduces pain during outpatient endometrial biopsy by comparing active and placebo devices in 135 participants. The study found a statistically significant but clinically insignificant reduction in immediate post-procedural pain scores for the active TENS group compared to placebo, with no other time points showing significant differences. However, patients reported higher satisfaction with pain control and were more likely to use the device again, while experiencing minimal side effects such as skin itching. This paper is centrally about endometriosis — specifically, it investigates analgesic methods for endometrial biopsy, a diagnostic procedure frequently performed in the evaluation of abnormal uterine bleeding associated with endometriosis or adenomyosis.

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Abstract

OBJECTIVE: To evaluate whether transcutaneous electric nerve stimulation (TENS) decreases pain at the time of outpatient endometrial biopsy. METHODS: We conducted a randomized, double-blind trial of active TENS compared with placebo TENS at the time of endometrial biopsy. The primary outcome was pain measured on a 0- to 100-mm visual analog scale immediately after biopsy, with secondary outcomes including satisfaction and tolerability of TENS and pain scores at other procedural time points. To detect a 15-mm reduction in pain with a 30-mm SD, 80.0% power, and a significance level of 0.05, 64 participants were required in each arm. RESULTS: From December 2022 to December 2023, 135 participants were randomized with 67 in the placebo TENS arm and 68 in the active TENS arm. Baseline demographic and clinical characteristics were similar between groups. The median (interquartile range) pain score immediately after biopsy was 50 mm (20-80 mm) in the active TENS group and 60 mm (40-100 mm) in the placebo TENS group ( P =.039). Pain scores at other time intervals were not statistically significantly different. In a subset analysis, participants with higher-than-median baseline anxiety had postprocedural pain scores (interquartile range) of 50 mm (40-80 mm) in the active TENS group compared with 80 mm (50-100 mm) in the placebo TENS group. Overall satisfaction (interquartile range) with pain control (with 100 mm representing completely satisfied) was 87.5 mm (60-100 mm) for active TENS and 70 mm (41-100 mm) for placebo TENS; 85.3% of active TENS participants would use TENS in a future endometrial biopsy. Minimal side effects were associated with TENS, with one participant reporting itching at the pad sites. CONCLUSION: Despite a statistical difference in pain scores, a clinical difference was not seen between active and placebo TENS for pain during endometrial biopsy. Satisfaction was higher in the active TENS group, and there were overall minimal side effects associated with TENS. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT05472740.
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Objective

To evaluate whether transcutaneous electric nerve stimulation (TENS) decreases pain at the time of outpatient endometrial biopsy.

Methods

We conducted a randomized, double-blind trial of active TENS compared with placebo TENS at the time of endometrial biopsy. The primary outcome was pain measured on a 0- to 100-mm visual analog scale immediately after biopsy, with secondary outcomes including satisfaction and tolerability of TENS and pain scores at other procedural time points. To detect a 15-mm reduction in pain with a 30-mm SD, 80.0% power, and a significance level of 0.05, 64 participants were required in each arm.

Results

From December 2022 to December 2023, 135 participants were randomized with 67 in the placebo TENS arm and 68 in the active TENS arm. Baseline demographic and clinical characteristics were similar between groups. The median (interquartile range) pain score immediately after biopsy was 50 mm (20–80 mm) in the active TENS group and 60 mm (40–100 mm) in the placebo TENS group (P=.039). Pain scores at other time intervals were not statistically significantly different. In a subset analysis, participants with higher-than-median baseline anxiety had postprocedural pain scores (interquartile range) of 50 mm (40–80 mm) in the active TENS group compared with 80 mm (50–100 mm) in the placebo TENS group. Overall satisfaction (interquartile range) with pain control (with 100 mm representing completely satisfied) was 87.5 mm (60–100 mm) for active TENS and 70 mm (41–100 mm) for placebo TENS; 85.3% of active TENS participants would use TENS in a future endometrial biopsy. Minimal side effects were associated with TENS, with one participant reporting itching at the pad sites.

Conclusion

Despite a statistical difference in pain scores, a clinical difference was not seen between active and placebo TENS for pain during endometrial biopsy. Satisfaction was higher in the active TENS group, and there were overall minimal side effects associated with TENS. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT05472740. In this randomized controlled trial, there was a statistically but not clinically significant reduction in pain after endometrial biopsy when patients used active compared with placebo transcutaneous electric nerve stimulation.

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MeSH descriptors

Endometrium Endometrium Pain Measurement Transcutaneous Electric Nerve Stimulation Transcutaneous Electric Nerve Stimulation Adult Biopsy Biopsy Biopsy Double-Blind Method Female Humans Middle Aged Pain Management Pain Management Patient Satisfaction Procedural Pain Procedural Pain Procedural Pain

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openalex
last seen: 2026-06-10T17:14:06.276822+00:00
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