Effectiveness of the Transcutaneous Electrical Nerve Stimulation in Dysmenorrhea

Dysmenorrhea Clinical Trial

Official title:

Investigation of the Effectiveness of Different Modulations of Pulse Frequency Transcutaneous Electrical Nerve Stimulation in Dysmenorrhea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01455285
• Other study ID #: 0377.0.045.000-10
• Status: Completed
• Phase: N/A
• First received: October 11, 2011
• Last updated: October 18, 2011

Study information

• Verified date: May 2011
• Source: Universidade Federal do Piauí
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 33 Years

Eligibility

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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysmenorrhea

Intervention

Device:
• transcutaneous electrical nerve stimulation

Locations

Country	Name	City	State
Brazil	School of Physiotherapy Clinic UFPI / Campus Minister Reis Velloso	Parnaíba	Piauí

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Piauí

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Proctor ML, Smith CA, Farquhar CM, Stones RW. Transcutaneous electrical nerve stimulation and acupuncture for primary dysmenorrhoea. Cochrane Database Syst Rev. 2002;(1):CD002123. Review. — View Citation