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We propose to explore the effects of Transcutaneous Electrical Nerve Stimulation (TENS) therapy in the pain management of postpartum women.
A. Objectives
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Post-CS Routine Care | No Intervention | Routine pharmacologic care will be provided. | |
| Opioid Addicted Post-CS Routine Care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3-4 post-operative days |
| Acetominophen Dosage |
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Inclusion Criteria:
Exclusion Criteria:
- History of cardiac arrhythmia or pacemaker usage
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| Name | Affiliation | Role |
|---|---|---|
| Adrienne Simonds, PT PhD | Rutgers School of Health Professions | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08901 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26977696 | Background | 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. | |
| 3484553 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | Post-CS Routine Care | Routine pharmacologic care will be provided. |
| FG003 | Opioid Addicted Post-CS Routine Care | Routine pharmacologic care will be provided. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Participants were between 18 and 45 years to be eligible. Participant age was not retained after determining eligibility for enrollment. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 3-4 post-operative days |
|
Adverse event data were collected for the duration of the postpartum inpatient hospital stay, generally 3 to 4 days.
There were no adverse events reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Early termination of study because of COVID-19 pandemic limited number of enrolled subjects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Adrienne Simonds | Rutgers, The State University of New Jersey | 8565667190 | simondad@shp.rutgers.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 19, 2022 | May 17, 2023 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 11, 2024 | Jul 11, 2024 | SAP_005.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 26, 2020 | May 17, 2023 | ICF_004.pdf |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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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.
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Not able to be masked
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Routine pharmacologic care will be provided.
|
Total dosage of acetominophen in milligrams. Acetominophen is a non-opioid analgesic medication. |
| 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. | 3-4 postoperative days |
| Time to OOB | Time to get out of bed (OOB) measured in hours | 3-4 post-operative days |
| Time to First BM | Time to first bowel movement (BM) measured in hours | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 6 weeks postoperatively |
| 21830007 | 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. |
| 24283391 | 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. |
| 28594766 | 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. |
| 2892930 | 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. |
| 3540813 | 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. |
| 19710640 | 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. |
| BG001 | 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. |
| BG002 | Post-CS Routine Care | Routine pharmacologic care will be provided. |
| BG003 | Opioid Addicted Post-CS Routine Care | Routine pharmacologic care will be provided. |
| BG004 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | All participants were female. Males were excluded from this study. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | All participants received prenatal care from the Rutgers Medical Group Obstetrics and Gynecology or Maternal Fetal Medicine practices and the High Risk Obstetric Perinatal Clinic and delivered via Cesarean Section at Robert Wood Johnson University Hospital in New Brunswick, New Jersey, United States. | Number | participants |
|
| History of prior opioid addiction | A history of opioid addiction was sought for half the patients in this trial. | Count of Participants | Participants |
|
| Cesarean section delivery | All participants delivered via Cesarean Section. | Count of Participants | Participants |
|
| OG001 | 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. |
| OG002 | Post-CS Routine Care | Routine pharmacologic care will be provided. |
| OG003 | Opioid Addicted Post-CS Routine Care | Routine pharmacologic care will be provided. |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Milligrams | 3-4 post-operative days |
|
|
|
| Secondary | Acetominophen Dosage | Total dosage of acetominophen in milligrams. Acetominophen is a non-opioid analgesic medication. | Posted | Mean | Standard Deviation | Milligrams | 3-4 postoperative days |
|
|
|
| Secondary | Ibuprofen Dosage | Total ibuprofen dosage in milligrams. Ibuprofen is a non-steroidal anti-inflammatory (NSAID) medication used to reduce pain and inflammation. | Posted | Mean | Standard Deviation | Milligrams | 3-4 postoperative days |
|
|
|
| Secondary | Time to OOB | Time to get out of bed (OOB) measured in hours | Posted | Mean | Standard Deviation | hours | 3-4 post-operative days |
|
|
|
| Secondary | Time to First BM | Time to first bowel movement (BM) measured in hours | This data were not collected due to unanticipated error. | Posted | 3-4 post-operative days |
|
|
| Secondary | Level of Sedation | Level of sedation (0-10 scale) was measured by provider observation via a Visual Analogue Scale. Higher scores mean more sedation. | This data were not collected due to unanticipated error. | Posted | 3-4 post-operative days |
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 3-4 days postoperatively |
|
|
|
| Secondary | 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. | Posted | Mean | Full Range | score on a scale | 3-4 days postoperatively |
|
|
|
| Secondary | 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. | Posted | Mean | Full Range | score on a scale | 3-4 postoperative days |
|
|
|
| Secondary | 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. | Data was not collected because participants could not be reached. | Posted | 6 weeks postoperatively |
|
|
| Secondary | 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. | Data was not collected because participants could not be reached. | Posted | 6 weeks postoperatively |
|
|
| Secondary | 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. | Data was not collected because participants could not be reached. | Posted | 6 weeks postoperatively |
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | 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. | 0 | 3 | 0 | 3 | 0 | 3 |
| EG002 | Post-CS Routine Care | Routine pharmacologic care will be provided. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG003 | Opioid Addicted Post-CS Routine Care | Routine pharmacologic care will be provided. | 0 | 2 | 0 | 2 | 0 | 2 |
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| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|