Transcutaneous Electric Nerve StimulationNCT04399707
Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Pain Control
A study testing Transcutaneous electrical nerve stimulation (TENS) unit in people with Transcutaneous Electric Nerve Stimulation and Analgesia, run by Hawaii Pacific Health at 1 site in United States.
Trial summary
Purpose of study is to evaluate the efficacy of transcutaneous electrical nerve stimulation (TENS) for post-operative pain control after a cesarean delivery compared to placebo and no TENS. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Transcutaneous Electric Nerve Stimulation, Analgesia, Cesarean Section
- What is being tested?
- Transcutaneous electrical nerve stimulation (TENS) unit
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2020to May 2021
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women undergoing scheduled or non-urgent cesarean section
Who cannot join
- Non-English speaking
- Subjects with a history of chronic pain or chronic opioid use
- Pre-operative use of opioids for more than 1 week in the preceding 6 months
- Previous exposure to the TENS unit
- Women with an allergy or contraindication to narcotics/NSAIDs/acetaminophen
- Subjects who had a midline vertical skin incision during this operation
Show all 12Show fewer
- Subjects who did not receive intrathecal opioids at the time of their cesarean delivery
- Adhesive allergies
- Subjects with a pacemaker (due to the unknown effects of the TENS on the electrical activity of the heart)
- Intraoperative general anesthesia
- Inability to consent to the study
- Postpartum tubal ligation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kelly Yamasato contact
United States1 site, 1 recruiting
- Recruiting
Nicole Kurata
Honolulu, Hawaii, 96826
Nicole Kurata, 808-577-3344, nkurata@hawaii.edu
Kelly Yamasato, MD
About this study
Purpose of study is to evaluate the efficacy of transcutaneous electrical nerve stimulation (TENS) for post-operative pain control after a cesarean delivery compared to placebo and no TENS.
- Being tested
- Transcutaneous electrical nerve stimulation (TENS) unit, Placebo transcutaneous electrical nerve stimulation (TENS) unit
- Keywords
- TENS, Transcutaneous electric nerve stimulation, Cesarean analgesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical nerve stimulation (TENS) unitDevice
Patients will be randomized to active TENS unit, placebo TENS unit, or no TENS unit
Placebo transcutaneous electrical nerve stimulation (TENS) unitDevice
Patients will be randomized to active TENS unit, placebo TENS unit, or no TENS unit
| Study group | Role | What they receive |
|---|---|---|
| Active TENS Unit | Active comparator | Not described Receives: Device: Transcutaneous electrical nerve stimulation (TENS) unit |
| Placebo TENS Unit | Placebo comparator | Not described Receives: Device: Placebo transcutaneous electrical nerve stimulation (TENS) unit |
| No TENS Unit | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative narcotic consumption
Total postoperative narcotic consumption (measured in morphine equivalents)
Measured: First 60 hours post-operatively
Secondary outcomes (4)
Duration of hospitalization
Length of stay in hospital
Measured: From date of cesarean delivery until discharge from hospital, assessed up to 1 month
Pain assessed by numeric analog scale (NAS) (0-10; 0: no pain at all, 10: worst imaginable pain)
Pain scoring
Measured: On post-operative days 1, 2, 3, and day of discharge, assessed up to 1 month
Satisfaction with pain control assessed by NAS (0-10; 0: very dissatisfied, 10: very satisfied)
Pain control satisfaction
Measured: On post-operative days 1, 2, 3, and day of discharge, assessed up to 1 month
Adverse reactions to TENS unit
Adverse reactions to TENS unit
Measured: From date of randomization until date of discharge, assessed up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start29 Jan 2020
- Primary completionMay 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Transcutaneous Electric Nerve StimulationStudies of the same condition, open and under way.
- 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
- Participants are randomized to one of three groups in parallel for the duration of the study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hawaii Pacific Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelly Yamasato, MD, Hawaii Pacific Health
- Investigators
- Kelly Yamasato, Principal investigator, Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04399707
- Sponsor's protocol ID
- 2019-035
- Status last verified
- May 2020
- First submitted
- 18 Feb 2020
- Last updated
- 26 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Bateman BT, Franklin JM, Bykov K, Avorn J, Shrank WH, Brennan TA, Landon JE, Rathmell JP, Huybrechts KF, Fischer MA, Choudhry NK. Persistent opioid use following cesarean delivery: patterns and predictors among opioid-naive women. Am J Obstet Gynecol. 2016 Sep;215(3):353.e1-353.e18. doi: 10.1016/j.ajog.2016.03.016. Epub 2016 Mar 17.
PubMed 26996986Desantana JM, Sluka KA, Lauretti GR. High and low frequency TENS reduce postoperative pain intensity after laparoscopic tubal ligation: a randomized controlled trial. Clin J Pain. 2009 Jan;25(1):12-9. doi: 10.1097/AJP.0b013e31817d1070.
PubMed 19158541Bjordal JM, Johnson MI, Ljunggreen AE. Transcutaneous electrical nerve stimulation (TENS) can reduce postoperative analgesic consumption. A meta-analysis with assessment of optimal treatment parameters for postoperative pain. Eur J Pain. 2003;7(2):181-8. doi: 10.1016/S1090-3801(02)00098-8.
PubMed 12600800Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.
PubMed 26827847Dowswell T, Bedwell C, Lavender T, Neilson JP. Transcutaneous electrical nerve stimulation (TENS) for pain relief in labour. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD007214. doi: 10.1002/14651858.CD007214.pub2.
PubMed 19370680Kurata NB, Ghatnekar RJ, Mercer E, Chin JM, Kaneshiro B, Yamasato KS. Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Birth Pain Control: A Randomized Controlled Trial. Obstet Gynecol. 2022 Aug 1;140(2):174-180. doi: 10.1097/AOG.0000000000004798. Epub 2022 Jul 6.
PubMed 35852266
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Pain Control
- ClinicalTrials.gov ID
- NCT04399707
- Acronym / sponsor ID
- 2019-035
- Keywords
- TENS, Transcutaneous electric nerve stimulation, Cesarean analgesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Hawaii Pacific HealthUniversity, hospital or other
- Study start
- 29 Jan 2020 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 22 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose of study is to evaluate the efficacy of transcutaneous electrical nerve stimulation (TENS) for post-operative pain control after a cesarean delivery compared to placebo and no TENS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants are randomized to one of three groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Active TENS Unit | Active comparator | Device: Transcutaneous electrical nerve stimulation (TENS) unit |
| Placebo TENS Unit | Placebo comparator | Device: Placebo transcutaneous electrical nerve stimulation (TENS) unit |
| No TENS Unit | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women undergoing scheduled or non-urgent cesarean section
Key exclusion criteria (12 listed)
- Non-English speaking
- Subjects with a history of chronic pain or chronic opioid use
- Pre-operative use of opioids for more than 1 week in the preceding 6 months
- Previous exposure to the TENS unit
- Women with an allergy or contraindication to narcotics/NSAIDs/acetaminophen
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) unitPatients will be randomized to active TENS unit, placebo TENS unit, or no TENS unit | Device | Active TENS Unit |
| Placebo transcutaneous electrical nerve stimulation (TENS) unitPatients will be randomized to active TENS unit, placebo TENS unit, or no TENS unit | Device | Placebo TENS Unit |
Primary outcome
Post-operative narcotic consumption
Time frame: First 60 hours post-operatively
Total postoperative narcotic consumption (measured in morphine equivalents)
4 secondary outcomes
Duration of hospitalization
Time frame: From date of cesarean delivery until discharge from hospital, assessed up to 1 month
Pain assessed by numeric analog scale (NAS) (0-10; 0: no pain at all, 10: worst imaginable pain)
Time frame: On post-operative days 1, 2, 3, and day of discharge, assessed up to 1 month
Satisfaction with pain control assessed by NAS (0-10; 0: very dissatisfied, 10: very satisfied)
Time frame: On post-operative days 1, 2, 3, and day of discharge, assessed up to 1 month
Adverse reactions to TENS unit
Time frame: From date of randomization until date of discharge, assessed up to 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2020.
- Background: PubMed 26996986Bateman BT, Franklin JM, Bykov K, Avorn J, Shrank WH, Brennan TA, Landon JE, Rathmell JP, Huybrechts KF, Fischer MA, Choudhry NK. Persistent opioid use following cesarean delivery: patterns and predictors among opioid-naive women. Am J Obstet Gynecol. 2016 Sep;215(3):353.e1-353.e18. doi: 10.1016/j.ajog.2016.03.016. Epub 2016 Mar 17.
- Background: PubMed 19158541Desantana JM, Sluka KA, Lauretti GR. High and low frequency TENS reduce postoperative pain intensity after laparoscopic tubal ligation: a randomized controlled trial. Clin J Pain. 2009 Jan;25(1):12-9. doi: 10.1097/AJP.0b013e31817d1070.
- Background: PubMed 12600800Bjordal JM, Johnson MI, Ljunggreen AE. Transcutaneous electrical nerve stimulation (TENS) can reduce postoperative analgesic consumption. A meta-analysis with assessment of optimal treatment parameters for postoperative pain. Eur J Pain. 2003;7(2):181-8. doi: 10.1016/S1090-3801(02)00098-8.
- Background: PubMed 26827847Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.
- Background: PubMed 19370680Dowswell T, Bedwell C, Lavender T, Neilson JP. Transcutaneous electrical nerve stimulation (TENS) for pain relief in labour. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD007214. doi: 10.1002/14651858.CD007214.pub2.
- Derived from this study: PubMed 35852266Kurata NB, Ghatnekar RJ, Mercer E, Chin JM, Kaneshiro B, Yamasato KS. Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Birth Pain Control: A Randomized Controlled Trial. Obstet Gynecol. 2022 Aug 1;140(2):174-180. doi: 10.1097/AOG.0000000000004798. Epub 2022 Jul 6.
- 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.
Kelly Yamasato contact
Kelly Yamasato principal investigator
Physician
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) unit in people with Transcutaneous Electric Nerve Stimulation and Analgesia, run by Hawaii Pacific Health 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 1 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 26 May 2020. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Kurata ((808)577-3344, nkurata@hawaii.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative narcotic consumption (time frame: First 60 hours post-operatively). 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 NCT04399707, which also lists 6 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 26 May 2020.