A randomized controlled trial of transcutaneous electrical nerve stimulation for pain control during intrauterine device insertion
Awarded 2023
Uta Landy Complex Family Planning Scholars
Lauren Kus, MD
Icahn School of Medicine at Mount Sinai

Few effective interventions exist to ease pain during IUD insertion, despite how frequently this procedure is performed in the US. Studies evaluating pharmacologic interventions demonstrate mixed results and there is limited investigation into non-pharmacologic pain control strategies. We propose a randomized controlled trial to assess the utility of transcutaneous electrical nerve stimulation (TENS) to reduce pain with IUD insertion. High-frequency TENS is a low-cost, widely available medical device with proven efficacy for managing pain associated with a variety of indications, including other gynecologic conditions and procedures. However, use with IUD insertion has not previously been studied. We will compare pain scores on a 100 mm visual analogue scale (VAS) recorded at the time of IUD (LNG 52 mg or copper T380A) insertion among individuals exposed to active or placebo treatment to determine if use imparts a clinically meaningful reduction in pain. We will enroll 98 patients (49 in each arm) to detect a clinically significant difference in VAS scores of 20 mm with a power of 85%. In addition to self- reported pain scores during IUD insertion, we will collect baseline demographic and medical history along with other characteristics such as pre-procedure anxiety and anticipated procedural pain to identify factors that may be associated with higher pain scores with this procedure. This study addresses a gap in knowledge about a routine, frequently painful, ambulatory gynecologic procedure and may propose a practical and feasible intervention for routine pain management in this context.