Cesarean Section ComplicationsNCT03843788
TENS and Opioid Use After Cesarean Delivery
A study testing Transcutaneous Electrical Nerve Stimulation (TENS) in people with Cesarean Section Complications and Opioid Use, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section Complications, Opioid Use
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation (TENS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2018to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- History of cardiac arrhythmia or pacemaker usage
Trial locations and contacts
1 site in 1 country.
United States1 site
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
About this study
Official title: Transcutaneous Electrical Nerve Stimulation and Maternal Opioid Use After Cesarean Delivery
We propose to explore the effects of Transcutaneous Electrical Nerve Stimulation (TENS) therapy in the pain management of postpartum women.
- Objectives
Read more
- 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.
- 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.
Read the detailed description
OVERVIEW. This study is a pilot randomized interventional trial. Two categories of participants will be randomly assigned to an invention or control group, using a random number generator: normal cesarean without associated comorbidity, or cesarean in women with a history of opioid addiction. The control group will receive usual care. The intervention group will receive usual care plus TENS therapy beginning 8 hours after cesarean section and continuing to discharge. Both groups will receive medications for pain as requested or ordered by the doctor.
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
- Cesarean Section Complications, Opioid Use
- Being tested
- Transcutaneous Electrical Nerve Stimulation (TENS)
- Keywords
- Post-cesarean pain, Transcutaneous Electrical Nerve Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-4 post-operative days
Secondary outcomes (12)
Milligrams Morphine Equivalent
Milligrams morphine equivalent (MME) is a standardized method of totaling dose of opioid medication. MME uses a conversion factor to convert opioid medication dosages into morphine equivalents, in milligrams.
Measured: 3-4 post-operative days
Acetominophen Dosage
Total dosage of acetominophen in milligrams. Acetominophen is a non-opioid analgesic medication.
Measured: 3-4 postoperative days
Ibuprofen Dosage
Total ibuprofen dosage in milligrams. Ibuprofen is a non-steroidal anti-inflammatory (NSAID) medication used to reduce pain and inflammation.
Measured: 3-4 postoperative days
Time to OOB
Time to get out of bed (OOB) measured in hours
Measured: 3-4 post-operative days
Time to First BM
Time to first bowel movement (BM) measured in hours
Measured: 3-4 post-operative days
Level of Sedation
Level of sedation (0-10 scale) was measured by provider observation via a Visual Analogue Scale. Higher scores mean more sedation.
Measured: 3-4 post-operative days
Number of Participants Who Found the Device Acceptable
Device acceptability questionnaire asked participants in the intervention group if TENS positively impacted their recovery. Responses indicated the number of participants who indicated "Yes" that TENS positively impacted their recovery. Responses of "Unsure" or "No" were coded as "No" responses.
Measured: 3-4 days postoperatively
McGill Pain Questionnaire
The Short-Form McGill Pain Questionnaire (SFMPQ) includes 15 items that describe the type of pain from sensory and affective domains. Each item is scored 0 to 3, with scores>1 indicating that pain aligns with that descriptor. Higher scores indicate more severe symptoms. The score range is 0 to 78, with 78 representing more severe pain.
Measured: 3-4 days postoperatively
Neuropathic Pain Scale (NPS)
Neuropathic Pain Scale (NPS) is a 10-item self-questionnaire that measures the degree of neuropathic pain. Higher scores indicate more severe pain. Total score ranges from 0 to 100, with 100 indicating the most severe neuropathic pain. Total NPS score is reported.
Measured: 3-4 postoperative days
Acceptability Questionnaire
Device acceptability questionnaire included 5 total self-report questions. Device usage (time used) and discharge medications were text entry questions. Three yes/no questions asked about impacts on pain relief, recovery and breastfeeding.
Measured: 6 weeks postoperatively
McGill Pain Questionnaire
The Short-Form McGill Pain Questionnaire (SFMPQ) includes 15 items that describe the type of pain from sensory and affective domains. Each item is scored 0 to 3, with scores>1 indicating that pain aligns with that descriptor. Higher scores indicate more severe symptoms.
Measured: 6 weeks postoperatively
Neuropathic Pain Scale
Neuropathic Pain Scale (NPS) is a 10-item questionnaire that measures the degree of neuropathic pain. Higher scores indicate more severe pain.
Measured: 6 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start9 Nov 2018
- Primary completion31 Jan 2020
- Study completion31 Mar 2020
Why it stopped: COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrienne Simonds PT PhD, Rutgers, The State University of New Jersey
- Investigators
- Adrienne Simonds, PT PhD, Principal investigator, Rutgers School of Health Professions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843788
- Sponsor's protocol ID
- Pro2018001008
- Status last verified
- Oct 2024
- First submitted
- 7 Aug 2018
- Last updated
- 29 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 26977696Hollinger JL. Transcutaneous electrical nerve stimulation after cesarean birth. Phys Ther. 1986 Jan;66(1):36-8. doi: 10.1093/ptj/66.1.36.
PubMed 3484553Citak 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.
PubMed 21830007Kayman-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.
PubMed 24283391Osmundson 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.
PubMed 28594766Reynolds 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.
PubMed 2892930Smith 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.
PubMed 3540813Willmann 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.
PubMed 19710640
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Nerve Stimulation and Maternal Opioid Use After Cesarean Delivery
- ClinicalTrials.gov ID
- NCT03843788
- Acronym / sponsor ID
- Pro2018001008
- Conditions
- Cesarean Section Complications, Opioid Use
- Keywords
- Post-cesarean pain, Transcutaneous Electrical Nerve Stimulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 pandemic
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 9 Nov 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 18 Feb 2019 (actual)
- Results
- Posted 29 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We propose to explore the effects of Transcutaneous Electrical Nerve Stimulation (TENS) therapy in the pain management of postpartum women.
- 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.
- 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.
Detailed description
OVERVIEW. This study is a pilot randomized interventional trial. Two categories of participants will be randomly assigned to an invention or control group, using a random number generator: normal cesarean without associated comorbidity, or cesarean in women with a history of opioid addiction. The control group will receive usual care. The intervention group will receive usual care plus TENS therapy beginning 8 hours after cesarean section and continuing to discharge. Both groups will receive medications for pain as requested or ordered by the doctor.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Post-CS TENS | Experimental | Device: Transcutaneous Electrical Nerve Stimulation (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. |
| Opioid Addicted Post-CS TENS | Experimental | Device: Transcutaneous Electrical Nerve Stimulation (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. |
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- History of cardiac arrhythmia or pacemaker usage
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 |
|---|---|---|
| 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. | Device | Opioid Addicted Post-CS TENS, Post-CS TENS |
Primary outcome
Post-operative Pain Ratings
Time frame: 3-4 post-operative days
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.
12 secondary outcomes
Milligrams Morphine Equivalent
Time frame: 3-4 post-operative days
Acetominophen Dosage
Time frame: 3-4 postoperative days
Ibuprofen Dosage
Time frame: 3-4 postoperative days
Time to OOB
Time frame: 3-4 post-operative days
Time to First BM
Time frame: 3-4 post-operative days
Level of Sedation
Time frame: 3-4 post-operative days
Number of Participants Who Found the Device Acceptable
Time frame: 3-4 days postoperatively
McGill Pain Questionnaire
Time frame: 3-4 days postoperatively
Neuropathic Pain Scale (NPS)
Time frame: 3-4 postoperative days
Acceptability Questionnaire
Time frame: 6 weeks postoperatively
McGill Pain Questionnaire
Time frame: 6 weeks postoperatively
Neuropathic Pain Scale
Time frame: 6 weeks postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26977696Dowell 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.
- Background: PubMed 3484553Hollinger JL. Transcutaneous electrical nerve stimulation after cesarean birth. Phys Ther. 1986 Jan;66(1):36-8. doi: 10.1093/ptj/66.1.36.
- Background: PubMed 21830007Citak 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.
- Background: PubMed 24283391Kayman-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.
- Background: PubMed 28594766Osmundson 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.
- Background: PubMed 2892930Reynolds 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.
- Background: PubMed 3540813Smith 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.
- Background: PubMed 19710640Willmann 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Adrienne Simonds, PT PhD principal investigator
Rutgers School of Health Professions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Nerve Stimulation (TENS) in people with Cesarean Section Complications and Opioid Use, run by Rutgers, The State University of New Jersey 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 4 inclusion and 1 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: stopped early, as of the sponsor's last update on 29 Oct 2024. 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. 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?
Yes. Results are posted in the registry (first posted 29 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative Pain Ratings (time frame: 3-4 post-operative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03843788, which also lists 8 linked publications.
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 29 Oct 2024.