Transcutaneous Electrical Nerve Stimulation (TENS) for Cesarean Section Complications

N/A

Waitlist Available

Led By Adrienne Simonds, PT PhD

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-4 post-operative days

Awards & highlights

Study Summary

This trial will explore the effects of Transcutaneous Electrical Nerve Stimulation (TENS) therapy in the pain management of postpartum women. TENS is a non-invasive, drug-free method of pain relief that works by stimulating the nerves with electrical impulses. The study will test whether or not TENS is effective in reducing pain and the need for pain medication in postpartum women. Additionally, the study will evaluate if TENS has any other benefits in postpartum outcomes, such as time to bowel movement, level of sedation, and time to out of bed.

Eligible Conditions

Cesarean Section Complications
Opioid Use Disorder

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-4 post-operative days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-4 post-operative days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-4 post-operative days for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Post-operative Pain Ratings

Secondary outcome measures

Post-operative opioid side-effects

Post-operative opioid use

Subjective Pain and Acceptability Questionnaire

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Post-CS TENSExperimental Treatment1 Intervention

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.

Group II: Opioid Addicted Post-CS TENSExperimental Treatment1 Intervention

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.

Group III: Post-CS Routine CareActive Control1 Intervention

Routine pharmacologic care will be provided.

Group IV: Opioid Addicted Post-CS Routine CareActive Control1 Intervention

Routine pharmacologic care will be provided.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcutaneous Electrical Nerve Stimulation (TENS)

2023

N/A

~680