PainTENSNCT06991075
Transcutaneous Electrical Nerve Stimulation for Pain Mitigation During Intrauterine Device Placement
A study testing High frequency transcutaneous electrical nerve stimulation in people with Pain, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain
- What is being tested?
- High frequency transcutaneous electrical nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MUSC Women's Health- Cannon Street
Charleston, South Carolina, 29425
Angela Dempsey, MD, 843-792-5300
Angela Dempsey, MD
About this study
Official title: A Randomized Controlled Trial of Transcutaneous Electrical Nerve Stimulation for Pain Mitigation During Intrauterine Device Placement
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.
Read the 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.
- Conditions
- Pain
- Being tested
- High frequency transcutaneous electrical nerve stimulation
- Keywords
- Obstetrics and Gynecology
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High frequency transcutaneous electrical nerve stimulationDevice
TENS 7000 digital TENS unit will be used.
| Study group | Role | What they receive |
|---|---|---|
| Active TENS | Active comparator | 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. Receives: Device: High frequency transcutaneous electrical nerve stimulation |
| Placebo TENS | Placebo comparator | 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. Receives: Device: High frequency transcutaneous electrical nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores reported at IUD insertion
Pain scores at time of IUD insertion as measured by VAS scores between TENS and placebo groups
Measured: From enrollment until 5 minutes after procedure completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start1 Dec 2025
- Primary completionAug 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Responsible party
- Principal investigator, Michelle Meglin, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06991075
- Sponsor's protocol ID
- Pro00143776
- Acronym
- TENS
- Status last verified
- Sep 2026
- First submitted
- 22 May 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: De-identified individual participant data will be analyzed according to the statistical plan for manuscript preparation and journal publication. Individual participant data will be shared within the study team including our collaborators at Icahn School of Medicine at Mount Sinai. Also, IPD will be shared with the IRB according to institutional guidelines.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Transcutaneous Electrical Nerve Stimulation for Pain Mitigation During Intrauterine Device Placement
- ClinicalTrials.gov ID
- NCT06991075
- Acronym / sponsor ID
- TENS / Pro00143776
- Conditions
- Pain
- Keywords
- Obstetrics and Gynecology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active TENS | Active comparator | Device: High frequency transcutaneous electrical nerve stimulationA 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 TENS | Placebo comparator | Device: High frequency transcutaneous electrical nerve stimulationA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High frequency transcutaneous electrical nerve stimulationTENS 7000 digital TENS unit will be used. | Device | Active TENS, Placebo TENS |
Primary outcome
Pain scores reported at IUD insertion
Time frame: From enrollment until 5 minutes after procedure completion
Pain scores at time of IUD insertion as measured by VAS scores between TENS and placebo groups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No. De-identified individual participant data will be analyzed according to the statistical plan for manuscript preparation and journal publication. Individual participant data will be shared within the study team including our collaborators at Icahn School of Medicine at Mount Sinai. Also, IPD will be shared with the IRB according to institutional guidelines.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High frequency transcutaneous electrical nerve stimulation in people with Pain, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jesslyn Payne ((843)-792-7525, paynej@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores reported at IUD insertion (time frame: From enrollment until 5 minutes after procedure completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.