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Behavioural Intervention

TENS for Endometrial Biopsy Pain

N/A

Waitlist Available

Led By Laura Havrilesky, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of procedure

Awards & highlights

Study Summary

This triallooks at whether a device used to reduce pain during procedures can help reduce discomfort during an endometrial biopsy. Possible benefits include reduced pain; risk of skin reaction from device.

Who is the study for?

This trial is for patients at least 18 years old from Duke's gynecology clinics who are undergoing an outpatient endometrial biopsy. It's not for those with prior TENS experience, skin damage where the TENS would be placed, heart devices like pacemakers, or if they can't follow instructions.Check my eligibility

What is being tested?

The study tests if a low-risk device called TENS can reduce pain during an endometrial biopsy. Participants will use this FDA-approved device that sends electrical impulses through the skin to potentially ease discomfort.See study design

What are the potential side effects?

Using the TENS unit is very low-risk but may cause minor skin reactions where the pads are attached. There aren't many side effects reported with its use in various medical situations.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pain after Endometrial Biopsy, as measured by Visual Analogue Scale (VAS)

Secondary outcome measures

Change in Pain, as measured by Visual Analogue Scale (VAS) across different time intervals

Number of participants who find the intervention acceptable based on survey response

Number of participants who find the intervention tolerable based on survey response

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active TENSExperimental Treatment1 Intervention

Participants will be connected to a TENS 7000 that is turned on and working

Group II: Placebo TENSPlacebo Group1 Intervention

Participants will be connected to a TENS 7000 however it will not be connected / will not be working

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TENS 7000

2022

N/A

~150

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,359 Previous Clinical Trials

3,420,073 Total Patients Enrolled

1 Trials studying Endometriosis

400 Patients Enrolled for Endometriosis

Laura Havrilesky, MDPrincipal InvestigatorDuke University

3 Previous Clinical Trials

252 Total Patients Enrolled

Media Library

TENS 7000 (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05472740 — N/A

Endometriosis Research Study Groups: Placebo TENS, Active TENS

Endometriosis Clinical Trial 2023: TENS 7000 Highlights & Side Effects. Trial Name: NCT05472740 — N/A

TENS 7000 (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05472740 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are fresh participants being welcomed into this clinical trial?

"Per data hosted on clinicaltrials.gov, this medical trial is accepting applicants. The listing was initially posted on December 13th 2022 and the contents were recently amended on December 19th 2022."

Answered by AI

What is the scope of subjects in this trial?

"Yes, the evidence provided on clinicaltrials.gov highlights that this medical trial is currently accepting applicants. Initially posted in December 13th 2022, it was recently updated and they are aiming to recruit 160 patients at one centre."

Answered by AI

Recent research and studies

Obstetrics & GynecologyJournal

Transcutaneous Electrical Nerve Stimulation for Pain Management of Aspiration Abortion up to 83 Days of Gestation

Lerma, Klaira, Lisa M. Goldthwaite, Paul D. Blumenthal, and Kate A. Shaw. 2021. “Transcutaneous Electrical Nerve Stimulation for Pain Management of Aspiration Abortion up to 83 Days of Gestation”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aog.0000000000004502.

clinicaltrials.govStudy

Transcutaneous Electrical Nerve Stimulation During Outpatient Endometrial Biopsy

2022. "Transcutaneous Electrical Nerve Stimulation During Outpatient Endometrial Biopsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05472740.