Clinical trial NCT06991075: Transcutaneous Electrical Nerve Stimulation for Pain Mitigation During Intrauterine Device Placement
Official title: A Randomized Controlled Trial of Transcutaneous Electrical Nerve Stimulation for Pain Mitigation During Intrauterine Device Placement
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain
Keywords: Obstetrics and Gynecology
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
First posted: 2025-05-25
Enrollment: 86
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigators are conducting a study to determine whether high frequency transcutaneous electrical nerve stimulation (hfTENS) is effective at reducing pain in women having an IUD inserted.

Detailed description: The intrauterine device (IUD) is a highly effective contraceptive method with increasing utilization in the last decade. The procedure to both place and remove an IUD is typically performed in the ambulatory gynecologic clinic. Pain associated with IUD insertion is variably described, and evidence suggests that physicians underestimate the severity of pain patients experience with this procedure. Studies have quantified the experience of pain using visual analog scales, demonstrating moderate insertional pain ranging from 5 to 7 out of 10 cm (equivalent to 50-70 out of 100 mm) on VAS. Increasingly, both academic and lay media reports highlight that traumatic nature of a painful IUD placement and call providers to acknowledge and address the pain of IUD placement in a meaningful way.

To date, research has not identified a highly effective strategy to reduce pain during IUD placement. Transcutaneous electrical nerve stimulation (TENS) is a low-cost, low-risk, nonpharmacologic intervention for pain management. The handheld device works by transmitting an electronically generated topical stimulus to a specified area on the body to alter response to pain signals and promote endogenous endorphin release for pain reduction. High frequency TENS (\>50 Hz; "hfTENS") significantly reduces pain associated with dysmenorrhea and a range of outpatient gynecologic procedures, including medication abortion, hysteroscopy, and uterine aspiration. This study evaluates an intervention to address pain during IUD placement in the ambulatory setting.

Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated informed consent form for IUD Insertion
* Stated willingness to comply with all study procedures
* English speaking individuals aged 18 years or older
* Presenting for IUD initiation during ambulatory care visit at MUSC Women's Health
* Opting for either LNG 52mg or copper T380A IUD

Exclusion Criteria:

* Contraindication to IUD initiation (i.e. pregnancy, current pelvic infection, distorted uterine anatomy)
* Contraindication or allergy to ibuprofen
* History of a chronic pain disorder
* Recent opioid use in the previous 30 days
* History of a cardiac arrhythmia
* History of heart disease (i.e. atrial fibrillation, congestive heart failure)
* Presence of an implantable device with an electrical discharge (i.e. pacemaker)
* BMI \> 50 (class IV obesity)
* History of TENS use
* Planned pain intervention outside standard of care (i.e. paracervical block, misoprotol) OR preprocedure use of non-standard pain medication (i.e. benzodiazepines, marijuana, muscle relaxers, gabapentin, benadryl)
* History of epilepsy

Primary outcomes:
measure: Pain scores reported at IUD insertion
timeFrame: From enrollment until 5 minutes after procedure completion
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: MUSC Women's Health- Cannon Street
state: South Carolina
Study officials:
References: