Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
16 participants
INTERVENTIONAL
2018-11-09
2020-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Pain Control
NCT04399707
Effect of Modulation of TENS in Pain After Cesarean Section
NCT01897311
Transversalis Fascia Plane Blocks for Analgesia Post-cesarean Delivery
NCT03236324
Comparison of Different Methods of Pain Control After Cesarean Section for Patients on Buprenorphine or Methadone
NCT02091297
Prediction of Postoperative Pain by an Electrical Pain Stimulus
NCT00374504
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
RESEARCH PROCEDURES. Patients will be identified for participation in their prenatal visit, and will be approached for study inclusion. Physicians that have a direct treatment relationship with the patient will inform the patient about the study and invite them to enroll. Consent for participation will be reviewed with the principal investigator and signed prior to delivery hospitalization. Randomization will follow consent, and patients randomized to intervention will have teaching performed about how to use the device at the time of consent.
Following cesarean delivery, subjects will be re-approached in the Postpartum Unit at Robert Wood Johnson University Hospital by study staff. The TENS device will be again reviewed, and provided to the patient, with review of instructions for use. The patients in the intervention group will be educated on the proper way to utilize the 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. Study staff will provide a record for documentation of time on/off for the unit. On the day of discharge, study staff will collect the device, and conduct a short survey about pain score. They will then review pain scores, pain medication usage and other secondary outcomes in the patient's chart. Finally, pain will be reassessed at the subject's outpatient postpartum visits by study staff.
DATA COLLECTION. Our research team members will collect the following data points from the patient's inpatient medical record: pain scale scores, medication requests/prescriptions (including name, type, and amount), time to first bowel movement, subjective incision complaints, and time to OOB. Participants will complete a survey before discharge which will solicit additional information about the postpartum recovery experience with or without TENS therapy.
DURATION OF STUDY. Study duration will be no more than 12 weeks. This will include up to 6 weeks prior to delivery for study approach and consent, delivery hospitalization, and 6 weeks postpartum for pain assessments at postpartum visits. There will be no long term follow up.
PRIMARY and SECONDARY ENDPOINTS. Primary endpoint of this pilot study is a total of 10 normal patients undergoing cesarean, and 10 patients with history of opioid addiction. Intervention will be performed in 5 patients in each group. Safety data will be reviewed following the first 10 patients to evaluate for worsening patient scores relative to controls.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Post-CS TENS
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.
Transcutaneous Electrical Nerve Stimulation (TENS)
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
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.
Transcutaneous Electrical Nerve Stimulation (TENS)
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.
Post-CS Routine Care
Routine pharmacologic care will be provided.
No interventions assigned to this group
Opioid Addicted Post-CS Routine Care
Routine pharmacologic care will be provided.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Transcutaneous Electrical Nerve Stimulation (TENS)
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
18 Years
45 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Rutgers, The State University of New Jersey
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Adrienne Simonds PT PhD
Assistant Professor of Rehabilitation and Movement Sciences,
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Adrienne Simonds, PT PhD
Role: PRINCIPAL_INVESTIGATOR
Rutgers School of Health Professions
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Hollinger JL. Transcutaneous electrical nerve stimulation after cesarean birth. Phys Ther. 1986 Jan;66(1):36-8. doi: 10.1093/ptj/66.1.36.
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.
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.
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.
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.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Pro2018001008
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.