- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01897311
Effect of Modulation of TENS in Pain After Cesarean Section
April 20, 2017 updated by: Janaina Mayer de Oliveira Nunes, Universidade Federal do Piauí
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Piauí
-
Parnaíba, Piauí, Brazil, 64204-100
- Santa Casa de Misericordia Hospital and State Hospital Dirceu Arco Verde
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 42 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: grupo TENS com frequência de 100 Hz
TENS application of high frequency (100 Hz, 100 μs)
|
|
Experimental: grupo TENS com frequência de 4 Hz
Application of low-frequency TENS (4 Hz, 100 μs)
|
|
Placebo Comparator: Placebo with TENS off
TENS application when off
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Intensity of pain after cesarean
Time Frame: after TENS application
|
after TENS application
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Janaina Mayer de Oliveira Nunes, University Federal Piauí
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (Actual)
May 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
May 24, 2013
First Submitted That Met QC Criteria
July 10, 2013
First Posted (Estimate)
July 11, 2013
Study Record Updates
Last Update Posted (Actual)
April 21, 2017
Last Update Submitted That Met QC Criteria
April 20, 2017
Last Verified
July 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- 0295.0.045.000-11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
Clinical Trials on transcutaneous electrical nerve stimulation
-
Karolinska University HospitalActive, not recruitingHip Fractures | Hip Osteoarthritis | Orthopedic Disorder | Post Operative PainSweden
-
University of L'AquilaCompleted
-
University of Colorado, BoulderUniversity of Colorado, Denver; Colorado State UniversityWithdrawn
-
ADIR AssociationCompletedChronic Obstructive Pulmonary DiseaseFrance
-
Assistance Publique - Hôpitaux de ParisCompletedTendinopathy | Cervical Radiculopathy | Post-herpetic Neuralgia | Chronic Back Pain | Limbs Arthrosis | Non Arthrosic Limbs Arthralgia | Chronic Lomboradiculalgia | Post-surgical Peripheral Neuropathic Pain | Post Trauma Neuropathic Pain | Complex Regional Pain Syndrome Type I or IIFrance
-
University of Nove de JulhoRecruiting
-
University Hospital, ToulouseMinistry of Health, FranceTerminatedPeripheral Artery DiseaseFrance
-
Institut Cancerologie de l'OuestTerminated
-
Secretaria Municipal de Saúde de RolanteCentro Universitario La SalleUnknown
-
Hawra Al-DandanRecruitingOveractive Bladder SyndromeSaudi Arabia