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

Overview

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.

Interventions

• Device High frequency transcutaneous electrical nerve stimulation
  TENS 7000 digital TENS unit will be used.

Primary outcome measures

• Pain scores reported at IUD insertion [Time frame: From enrollment until 5 minutes after procedure completion]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• MUSC Women's Health- Cannon Street — Charleston

Identifiers

NCT: NCT06991075 · Pro00143776

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗