PainNCT01897311
Effect of Modulation of TENS in Pain After Cesarean Section
A study testing transcutaneous electrical nerve stimulation in people with Pain, run by Universidade Federal do Piauí at 1 site in Brazil.
Trial summary
The aim of the study was to evaluate the analgesic effect of transcutaneous electrical nerve stimulation High (100 Hz) and low (4 Hz) frequency in postpartum pain after cesarean section. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Pain
- What is being tested?
- transcutaneous electrical nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2011to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- aged 18 years
- present pain at the site of surgical incision less than three according to Category Numerical Scale (NRS)
- literate oriented as to time and space
- with spinal anesthesia before surgery
- incision pfannenstiel type with absence of genitourinary pathology
- primiparous or multiparous
Who cannot join
- patients with abnormal sensitivity to clinical examination
- demyelinating diseases
- spinal cord injury
- hemorrhage
- infection
- fever
- anesthetic complications
- hypertension, mammary, intolerance, irritation or strong discomfort at the injection site caused by TENS
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Santa Casa de Misericordia Hospital and State Hospital Dirceu Arco Verde
Parnaíba, Piauí, 64204-100
About this study
Official title: Hypoalgesic Effect of TENS Modulation in Post-Cesarean Pain: A Clinical Trial Controlled and Randomized.
The aim of the study was to evaluate the analgesic effect of transcutaneous electrical nerve stimulation High (100 Hz) and low (4 Hz) frequency in postpartum pain after cesarean section.
Read the detailed description
Mothers were randomly divided into three groups (G100, G4 and placebo (GP) - appliance off) and evaluated by NRS (numeric rating scale) before, immediately after application of TENS, and every 20 minutes until he was one hour after the application of electroanalgesia, to verify its effectiveness over time.
- Conditions
- Pain
- Being tested
- transcutaneous electrical nerve stimulation
- Keywords
- cesarean section, pain, transcutaneous electrical nerve stimulation, postpartum period
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous electrical nerve stimulationDevice
| Study group | Role | What they receive |
|---|---|---|
| grupo TENS com frequência de 100 Hz | Experimental | TENS application of high frequency (100 Hz, 100 μs) Receives: Device: transcutaneous electrical nerve stimulation |
| grupo TENS com frequência de 4 Hz | Experimental | Application of low-frequency TENS (4 Hz, 100 μs) Receives: Device: transcutaneous electrical nerve stimulation |
| Placebo with TENS off | Placebo comparator | TENS application when off Receives: Device: transcutaneous electrical nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of pain after cesarean
Measured: after TENS application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startAug 2011
- Primary completionMay 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Piauí
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janaina Mayer de Oliveira Nunes, Universidade Federal do Piauí
- Investigators
- Janaina Mayer de Oliveira Nunes, Principal investigator, University Federal Piauí
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01897311
- Sponsor's protocol ID
- 0295.0.045.000-11
- Status last verified
- Jul 2013
- First submitted
- 24 May 2013
- Last updated
- 21 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Zimpel SA, Torloni MR, Porfirio GJ, Flumignan RL, da Silva EM. Complementary and alternative therapies for post-caesarean pain. Cochrane Database Syst Rev. 2020 Sep 1;9(9):CD011216. doi: 10.1002/14651858.CD011216.pub2.
PubMed 32871021
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoalgesic Effect of TENS Modulation in Post-Cesarean Pain: A Clinical Trial Controlled and Randomized.
- ClinicalTrials.gov ID
- NCT01897311
- Acronym / sponsor ID
- 0295.0.045.000-11
- Conditions
- Pain
- Keywords
- cesarean section, pain, transcutaneous electrical nerve stimulation, postpartum period
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Universidade Federal do PiauíUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 11 Jul 2013 (estimated)
- 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.
The aim of the study was to evaluate the analgesic effect of transcutaneous electrical nerve stimulation High (100 Hz) and low (4 Hz) frequency in postpartum pain after cesarean section.
Detailed description
Mothers were randomly divided into three groups (G100, G4 and placebo (GP) - appliance off) and evaluated by NRS (numeric rating scale) before, immediately after application of TENS, and every 20 minutes until he was one hour after the application of electroanalgesia, to verify its effectiveness over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| grupo TENS com frequência de 100 Hz | Experimental | Device: transcutaneous electrical nerve stimulationTENS application of high frequency (100 Hz, 100 μs) |
| grupo TENS com frequência de 4 Hz | Experimental | Device: transcutaneous electrical nerve stimulationApplication of low-frequency TENS (4 Hz, 100 μs) |
| Placebo with TENS off | Placebo comparator | Device: transcutaneous electrical nerve stimulationTENS application when off |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- aged 18 years
- present pain at the site of surgical incision less than three according to Category Numerical Scale (NRS)
- literate oriented as to time and space
- with spinal anesthesia before surgery
- incision pfannenstiel type with absence of genitourinary pathology
Key exclusion criteria (8 listed)
- patients with abnormal sensitivity to clinical examination
- demyelinating diseases
- spinal cord injury
- hemorrhage
- infection
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 | Device | Placebo with TENS off, grupo TENS com frequência de 100 Hz, grupo TENS com frequência de 4 Hz |
Primary outcome
Intensity of pain after cesarean
Time frame: after TENS application
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
- Derived from this study: PubMed 32871021Zimpel SA, Torloni MR, Porfirio GJ, Flumignan RL, da Silva EM. Complementary and alternative therapies for post-caesarean pain. Cochrane Database Syst Rev. 2020 Sep 1;9(9):CD011216. doi: 10.1002/14651858.CD011216.pub2.
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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.
Janaina Mayer de Oliveira Nunes principal investigator
University Federal Piauí
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 in people with Pain, run by Universidade Federal do Piauí at 1 site in Brazil.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 21 Apr 2017. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intensity of pain after cesarean (time frame: after TENS application). 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 NCT01897311, which also lists 1 linked publication.
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 21 Apr 2017.