PainNCT06245655
Transcutaneous Electrical Nerve Stimulation (TENS) for IUD Insertion Pain
A study testing Transcutaneous Electrical Nerve Stimulation (TENS) in people with Pain, run by Icahn School of Medicine at Mount Sinai at 5 sites in United States.
Trial summary
This study is a double-blind, randomized, placebo-controlled trial to evaluate the use of high frequency TENS for pain control during IUD insertion. Transcutaneous electrical nerve stimulation (TENS) is a relatively low-cost, low-risk, non-pharmacologic intervention for pain management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation (TENS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 5 sitesUnited States
- Study dates
- 25 Mar 2024to 21 Apr 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to participate in the study, an individual must meet all the following criteria:
- Presenting for IUD initiation during ambulatory care visits to the Mount Sinai Complex Family Planning service
- Provision of signed and dated informed consent form for IUD Insertion
- English speaking and age 18 or older
- Opting for either LNG 52mg or copper T380A IUD
- Stated willingness to comply with all study procedures
Who cannot join
- 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)
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- 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) OR pre-procedure use of non-standard pain medication (i.e. benzodiazepines, muscle relaxers, gabapentin, benadryl)
- History of epilepsy
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Center for Women's Health and Midwifery
New Haven, Connecticut, 06519
Yale Family Planning Clinic
New Haven, Connecticut, 06519
Mount Sinai Beth Israel
New York, New York, 10003
Mount Sinai Union Square
New York, New York, 10003
Mount Sinai Hospital
New York, New York, 10029
About this study
Official title: A Randomized Controlled Trial of Transcutaneous Electrical Nerve Stimulation (TENS) for Treatment of IUD Insertion Pain
This study is a double-blind, randomized, placebo-controlled trial to evaluate the use of high frequency TENS for pain control during IUD insertion. Transcutaneous electrical nerve stimulation (TENS) is a relatively low-cost, low-risk, non-pharmacologic intervention for pain management. Previous studies have found that TENS reduces pain associated with other outpatient gynecological procedures. Participants will be randomized in a 1:1 ratio to either active treatment or placebo (placebo TENS) and record pain scores using a 100 mm visual analog scale (VAS) at the time of IUD insertion. The same device will be used for both active and placebo treatment.
Read the detailed description
The researchers will recruit eligible participants from patients who opt for IUD initiation during ambulatory care visits to the Mount Sinai Complex Family Planning service at Mount Sinai Hospital, Mount Sinai Beth Israel, Mount Sinai Morningside, and Mount Sinai West. Allocation to treatment will be based on a 1:1 blocked randomization scheme stratified by parity. A member of the research/clinical team other than the person performing IUD insertion will identify the treatment allocation assigned to the corresponding subject ID. The team member will set up the TENS unit accordingly by applying pads to the participant and initiating treatment with the correct settings. When setup is complete (<5 minutes), the person performing the IUD insertion and other clinical staff assisting with the procedure will enter the exam room with no knowledge of TENS treatment assignment to insert the IUD.
REDCap, a HIPAA-compliant, secure web application used for building and managing online surveys and databases, will be used for data collection in this study. Participants will complete electronic surveys in REDCap during the study. The first survey is a baseline survey to collect demographics as well as medical, obstetric, and gynecologic history and other characteristics prior to the IUD insertion procedure.
IUD insertion will be performed by complex family planning faculty and fellows, as well as OB/GYN residents on their family planning rotation. A research staff member will be within reach of the study participant during the procedure to collect pain scores using a visual analog scale (VAS) presented on an iPad.
The second survey will have a visual analog scale for study participants to rate their pain between 0 and 100 at the following timepoints during IUD insertion:
- Baseline
- Immediately after bimanual exam
- Immediately after speculum insertion
- Immediately after tenaculum placement
- Immediately after uterine sounding
- Immediately after IUD insertion
- 5 minutes after speculum removal
The third survey will ask participants about reflections on their experience with IUD insertion and acceptability of the TENS device. Participation in the study is expected to only last one day, the day of IUD insertion.
- Conditions
- Pain
- Being tested
- Transcutaneous Electrical Nerve Stimulation (TENS)
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve Stimulation (TENS)Device
TENS 7000 digital TENS unit, a low cost, over the counter, battery operated device with high consumer ratings. 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.
| Study group | Role | What they receive |
|---|---|---|
| Active TENS | Active comparator | For the Active TENS 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. Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS) |
| Placebo TENS | Placebo comparator | For the placebo TENS group, setup will be identical, but the device will not be turned on. Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score on Pain Visual Analog Scale
Participant reported maximum pain score on Pain Visual Analog Scale - full scale from 0-100, higher score indicates higher level of pain.
Measured: Day 1 (Day of IUD Insertion)
Secondary outcomes (2)
Maximum Pain Score on Pain Visual Analog Scale
Participant reported maximum pain score on Pain Visual Analog Scale - full scale from 0-100, higher score indicates higher level of pain.
Measured: Day 1 (Day of IUD Insertion)
Post Procedure Survey Question - Acceptability of the Device
Acceptability of the TENS device. Questions answered as yes or no. This is not a scale and has no min or max score.
Measured: Day 1 (Day of IUD Insertion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start25 Mar 2024
- Primary completion21 Apr 2025
- Study completion21 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lauren Kus, Icahn School of Medicine at Mount Sinai
- Investigators
- Lauren Kus, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245655
- Sponsor's protocol ID
- STUDY-23-01562
- Other IDs
- SFP17-UL4
- Status last verified
- Apr 2026
- First submitted
- 30 Jan 2024
- Last updated
- 6 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data meta-analysis for this study will not be done. De-identified individual participant data will be analyzed according to the statistical plan mentioned in the study protocol for manuscript preparation and journal publication. Individual participant data will be shared within the study team. Also, IPD will be shared with the IRB according to institutional guidelines.