TENS and Opioid Use After Cesarean Delivery

NCT03843788 | Terminated Results FDA Device

• 1 other identifier: Pro2018001008
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

We propose to explore the effects of Transcutaneous Electrical Nerve Stimulation (TENS) therapy in the pain management of postpartum women. A. Objectives

• To determine if the addition of TENS therapy to the pain management of women post-cesarean section leads to less opioid medication use.
• To evaluate the efficacy of TENS therapy as a means of alternative pain relief for women post-cesarean section with a history of opioid use. B. Hypotheses / Research Question(s) We hypothesize that patients that receive TENS therapy will report lower pain scores and request less opioid medication than the control group. We anticipate improved control in particular in the group of women with a history of opioid use. Additionally, we believe that the TENS therapy will show benefits in other postpartum outcomes including time to bowel movement, level of sedation, and time to out of bed. Overall, we anticipate that this pilot study will support the application of TENS therapy in postpartum pain management.

Conditions

Cesarean Section Complications; Opioid Use

Keywords

Post-cesarean pain; Transcutaneous Electrical Nerve Stimulation

Outcome Measures

Primary Outcomes (1)

• Post-operative Pain Ratings

  Post-operative pain rating (0-10 scale) using Visual Analog Scale (VAS). VAS scores correspond self-report pain intensity. Higher scores mean higher pain intensity.

  3-4 post-operative days

Secondary Outcomes (12)

• Milligrams Morphine Equivalent

  3-4 post-operative days

• Acetominophen Dosage

  3-4 postoperative days

• Ibuprofen Dosage

  3-4 postoperative days

• Time to OOB

  3-4 post-operative days

• Time to First BM

  3-4 post-operative days

Study Arms (4)

Post-CS TENS

EXPERIMENTAL

The patients in the intervention group will be educated on the proper way to utilize the transcutaneous electrical nerve stimulation (TENS) unit. They will apply the the patches of the TENS unit around the C-section site. Starting 8 hours after C-Section, the TENS unit will be turned on and will remain on until the patient is discharged, to be removed for toilet and showering at the patient's discretion. Once the TENS unit is applied and turned on, the patient will not have to do anything else to maintain the therapy. Routine pharmacologic care will also be available.

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Opioid Addicted Post-CS TENS

EXPERIMENTAL

Subjects will be targeted on the basis of opioid addiction and usage of methadone maintenance. The patients in the intervention group will be educated on the proper way to utilize the transcutaneous electrical nerve stimulation (TENS) unit. They will apply the the patches of the TENS unit around the C-section site). Starting 8 hours after C-Section, the TENS unit will be turned on and will remain on until the patient is discharged, to be removed for toilet and showering at the patient's discretion. Once the TENS unit is applied and turned on, the patient will not have to do anything else to maintain the therapy. Routine pharmacologic care will also be available.

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Post-CS Routine Care

NO INTERVENTION

Routine pharmacologic care will be provided.

Opioid Addicted Post-CS Routine Care

NO INTERVENTION

Routine pharmacologic care will be provided.

Interventions

Transcutaneous Electrical Nerve Stimulation (TENS) DEVICE

Starting 8 hours after cesarean section, the TENS unit will be applied with charges above and below the incision. The device will be set to high frequency (\>75 Hz) for pain relief. Intensity of stimulation will be set to patient threshold using the forearm as a guide. Stimulation will be turned on titrated to the level which is felt but not painful for the patient. It will remain on until the patient is discharged, to be removed for toilet and showering at the patient's discretion. Once the TENS unit is applied and turned on, the patient will not have to do anything else to maintain the therapy.

Opioid Addicted Post-CS TENS; Post-CS TENS

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged between 18 and 45 years
• Understand and be able to follow written and oral instructions in English
• Provide written informed consent
• History of prior opioid addiction for half of the patients.

You may not qualify if:

• \- History of cardiac arrhythmia or pacemaker usage

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

Location

Related Publications (8)

• Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain--United States, 2016. JAMA. 2016 Apr 19;315(15):1624-45. doi: 10.1001/jama.2016.1464.

  PMID: 26977696 BACKGROUND

• Hollinger JL. Transcutaneous electrical nerve stimulation after cesarean birth. Phys Ther. 1986 Jan;66(1):36-8. doi: 10.1093/ptj/66.1.36.

  PMID: 3484553 BACKGROUND

• Citak Karakaya I, Yuksel I, Akbayrak T, Demirturk F, Karakaya MG, Ozyuncu O, Beksac S. Effects of physiotherapy on pain and functional activities after cesarean delivery. Arch Gynecol Obstet. 2012 Mar;285(3):621-7. doi: 10.1007/s00404-011-2037-0. Epub 2011 Aug 10.

  PMID: 21830007 BACKGROUND

• Kayman-Kose S, Arioz DT, Toktas H, Koken G, Kanat-Pektas M, Kose M, Yilmazer M. Transcutaneous electrical nerve stimulation (TENS) for pain control after vaginal delivery and cesarean section. J Matern Fetal Neonatal Med. 2014 Oct;27(15):1572-5. doi: 10.3109/14767058.2013.870549. Epub 2014 Jan 8.

  PMID: 24283391 BACKGROUND

• Osmundson SS, Schornack LA, Grasch JL, Zuckerwise LC, Young JL, Richardson MG. Postdischarge Opioid Use After Cesarean Delivery. Obstet Gynecol. 2017 Jul;130(1):36-41. doi: 10.1097/AOG.0000000000002095.

  PMID: 28594766 BACKGROUND

• Reynolds RA, Gladstone N, Ansari AH. Transcutaneous electrical nerve stimulation for reducing narcotic use after cesarean section. J Reprod Med. 1987 Nov;32(11):843-6.

  PMID: 2892930 BACKGROUND

• Smith CM, Guralnick MS, Gelfand MM, Jeans ME. The effects of transcutaneous electrical nerve stimulation on post-cesarean pain. Pain. 1986 Nov;27(2):181-193. doi: 10.1016/0304-3959(86)90209-5.

  PMID: 3540813 BACKGROUND

• Willmann S, Edginton AN, Coboeken K, Ahr G, Lippert J. Risk to the breast-fed neonate from codeine treatment to the mother: a quantitative mechanistic modeling study. Clin Pharmacol Ther. 2009 Dec;86(6):634-43. doi: 10.1038/clpt.2009.151. Epub 2009 Aug 26.

  PMID: 19710640 BACKGROUND

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Limitations and Caveats

Early termination of study because of COVID-19 pandemic limited number of enrolled subjects.

Results Point of Contact

• Title: Dr. Adrienne Simonds
• Organization: Rutgers, The State University of New Jersey

simondad@shp.rutgers.edu

8565667190

Study Officials

• Adrienne Simonds, PT PhD

  Rutgers School of Health Professions

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not able to be masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Rehabilitation and Movement Sciences,

Model Details: This is a pilot feasibility study to evaluate effectiveness and acceptability in our patient population of TENS use throughout delivery hospitalization. We aim to have 20 participants total: 5 in control and 5 in intervention without history of opioid addiction, and 5 in control and 5 in intervention with history of opioid addiction/misuse. This sample size is comparable to other shorter term pilot studies. This pilot study will serve as the basis for larger trials in the future, with larger sample size powered to demonstrate reduction in pain scores. We anticipate recruitment for this trial will take approximately 6-9 months.

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: February 18, 2019
• Study Start: November 9, 2018
• Primary Completion: January 31, 2020
• Study Completion: March 31, 2020
• Last Updated: October 29, 2024
• Results First Posted: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)