NCT01455285

Brief Summary

Hypothesis: What is the best modulation of pulse frequency in transcutaneous electrical nerve stimulation in dysmenorrhea? Purpose: To determine the effect of hypoalgesia frequency modulation pulse by transcutaneous electrical nerve (TENS) in dysmenorrhea. Methods: A controlled clinical study and prospective developed at the School of Physiotherapy Clinic / UFPI. Forty students were randomized into four distinct groups of the modulation frequency TENS: group 1 - 100 Hz, 100μs, group 2 - 4 Hz, 100μs, group 3 - placebo (apparatus off), group 4 - placebo induced (2 Hz, 40μs). All were initially evaluated by a questionnaire developed for the study, the visual analogue scale (VAS) (before, after 20, 30, 40, 50, 60 minutes) and the McGill Pain Questionnaire (before and after 20 minutes). The total duration of TENS application was 20 minutes and all protocols were performed in a single session. The analysis of variance (One-way ANOVA) followed by the Tukey procedure was applied to identify differences between experimental groups for each variable analyzed. The level of significance was p\< 0,05.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 19, 2011

Completed
Last Updated

October 19, 2011

Status Verified

May 1, 2011

First QC Date

October 11, 2011

Last Update Submit

October 18, 2011

Conditions

Keywords

dysmenorrheatranscutaneous electrical nerve stimulation (TENSanalgesiapain visual analog scaleMcGill pain questionnaire

Interventions

Eligibility Criteria

Age16 Years - 33 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • be the first or second day of menstruation
  • dysmenorrhea present at the time of application of TENS
  • not having undergone any procedure analgesic six hours before the application of TENS

You may not qualify if:

  • not to mention dysmenorrhea at the time of evaluation
  • pregnant women
  • were using some method of hormonal contraception on an ongoing basis
  • had sensory deficits or cognitive and cases of contraindication to TENS application.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Physiotherapy Clinic UFPI / Campus Minister Reis Velloso

Parnaíba, Piauí, 64202-020, Brazil

Location

Related Publications (1)

  • Proctor ML, Smith CA, Farquhar CM, Stones RW. Transcutaneous electrical nerve stimulation and acupuncture for primary dysmenorrhoea. Cochrane Database Syst Rev. 2002;2002(1):CD002123. doi: 10.1002/14651858.CD002123.

MeSH Terms

Conditions

DysmenorrheaAgnosia

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 11, 2011

First Posted

October 19, 2011

Last Updated

October 19, 2011

Record last verified: 2011-05

Locations