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Effectiveness of the Transcutaneous Electrical Nerve Stimulation in Dysmenorrhea

Primary Purpose

Dysmenorrhea

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
transcutaneous electrical nerve stimulation
Sponsored by
Universidade Federal do Piauí
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysmenorrhea focused on measuring dysmenorrhea, transcutaneous electrical nerve stimulation (TENS, analgesia, pain visual analog scale, McGill pain questionnaire

Eligibility Criteria

16 Years - 33 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • School of Physiotherapy Clinic UFPI / Campus Minister Reis Velloso

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 11, 2011
Last Updated
October 18, 2011
Sponsor
Universidade Federal do Piauí
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1. Study Identification

Unique Protocol Identification Number
NCT01455285
Brief Title
Effectiveness of the Transcutaneous Electrical Nerve Stimulation in Dysmenorrhea
Official Title
Investigation of the Effectiveness of Different Modulations of Pulse Frequency Transcutaneous Electrical Nerve Stimulation in Dysmenorrhea
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Universidade Federal do Piauí

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmenorrhea
Keywords
dysmenorrhea, transcutaneous electrical nerve stimulation (TENS, analgesia, pain visual analog scale, McGill pain questionnaire

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
transcutaneous electrical nerve stimulation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
33 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Facility Information:
Facility Name
School of Physiotherapy Clinic UFPI / Campus Minister Reis Velloso
City
Parnaíba
State/Province
Piauí
ZIP/Postal Code
64202-020
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
11869624
Citation
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.
Results Reference
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Effectiveness of the Transcutaneous Electrical Nerve Stimulation in Dysmenorrhea

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