Transcutaneous Electrical Nerve Stimulation for Pain Mitigation During Intrauterine Device Placement

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT06991075
Status
Recruiting
Apply to this trial

Conditions

  • Pain

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 1, 2025
Status verified
Feb 2026
Primary completion
Aug 31, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
86 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active TENS
    A TENS 7000 digital TENS unit will be used. A research staff member will apply TENS pads to specified areas on the lower abdomen and lower back corresponding to T10-11 and S2-4 dermatomes. For the active treatment group, the device will be set to 80 Hz (hfTENS) and device intensity (0-8) will be titrated to patient comfort, as is the standard protocol for TENS use.
  • Placebo Comparator: Placebo TENS
    A TENS 7000 digital TENS unit will be used. A research staff member will apply TENS pads to specified areas on the lower abdomen and lower back corresponding to T10-11 and S2-4 dermatomes. The TENS device will not be turned on.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MUSC Women's Health- Cannon StreetCharlestonSouth Carolina29425
Angela Dempsey, MD
843-792-5300
Angela Dempsey, MD (SUB_INVESTIGATOR)

Find similar trials in Charleston, SC

By research site
MUSC Women's Health- Cannon Street· Charleston, SC

Related Studies