Application of Electrical Neurostimulation Transcutaneous in Patients With Primary Dysmenorrhea.

NCT02205970 | Completed

• 2 other identifiers: UFSaoCarlos0001/14036/2010
• Study Type: interventional
• Target: 124
• Locations: 0 countries
• Sites: N/A

Brief Summary

The present study aims to verify the analgesic potential of a new methodological proposal for application for transcutaneous electrical nerve stimulation (TENS interactive) using patients with primary dysmenorrhoea and compare it with placebo in a randomized double blind study with convenience sample.

Conditions

Primary Dysmenorrhea

Keywords

TENS; Dysmenorrhea; analgesia; interactive

Outcome Measures

Primary Outcomes (1)

• measure the pain threshold, used to Visual Analogue Scale (VAS)before and after application

  To assess pain intensity, will be used to Visual Analogue Scale (VAS), Assessments with EVA are performed before and after treatment of interactive TENS (proposed method). All selected volunteers were subjected to an application of TENS (active or sham) in a single menstrual cycle.

  participants will be monitored for 24 hours

Secondary Outcomes (1)

• duration of analgesia after application

  1 week

Study Arms (2)

TENS active

ACTIVE COMPARATOR

TENS (interactive): frequency (90 and 150 pps) and pulse duration (300 and 400μs)

Device: TENS

TENS sham

SHAM COMPARATOR

Placebo lasting 35 minutes.

Device: TENS (sham)

Interventions

TENS DEVICE

In the active group there was only one application with interactive TENS (n = 42) with the final parameters of frequency between 90 and 150pps and pulse duration between 300 and 400μs and intensity level of tolerance, lasting 35 minutes.

Also known as: TENS - eletric pulse generator

TENS active

TENS (sham) DEVICE

In the placebo group, there was a simulated single application, following the same procedures as the active TENS group, also for 35 minutes.

TENS sham

Eligibility Criteria

• Age: 18 Years - 36 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Primary dysmenorrhoea
• Moderate to severe pain

You may not qualify if:

• Secondary dysmenorrhea
• Users of intrauterine device
• Cognitive impairment
• Failure to appear for treatment
• Pacemaker use
• Illicit drug use
• Epilepsy
• Skin problems
• Use of pain medication before the application of TENS

Sponsors & Collaborators

• Universidade Federal de Sao Carlos: lead

MeSH Terms

Conditions

Dysmenorrhea; Agnosia

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Fábio M. Camilo, teacher

  Fundação de Educação e Cultura de Santa Fé do Sul

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: one arm study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Methodological Proposal of Application of Electrical Neurostimulation Transcutaneous (Comparative Study between Proposed Method of Application Versus Traditional method in patients with Primary Dysmenorrhea).

Study Record Dates

• First Submitted: July 28, 2014
• First Posted: August 1, 2014
• Study Start: August 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: October 23, 2017

Record last verified: 2017-10