Treatment of Dysmenorrhoea With the OVA TENS Apparatus

This study has been completed.
Sponsor:
Collaborator:
Vitacon AS, Vegamot 8, 7048 Trondheim, Norway
Information provided by:
The Hospital of Vestfold
ClinicalTrials.gov Identifier:
NCT00225836
First received: September 22, 2005
Last updated: January 12, 2007
Last verified: January 2007
  Purpose

Dysmenorrhoea (menstrual pain) is a common complaint among women, leading to use of analgesics, reduced quality of life, and interference with daily activities such as going to work or school.

Transcutaneous electrical nerve stimulation (TENS) is a well established method for treatment of pain. Several clinical studies have shown TENS treatment to be effective against dysmenorrhoea. A TENS apparatus specifically developed for the treatment of dysmenorrhoea has now become commercially available (OVA), but is has not been tested in clinical studies.

This study will be done to evaluate the clinical utility of treatment with OVA in women with primary dysmenorrhoea.


Condition Intervention
Dysmenorrhoea
Device: OVA (TENS apparatus)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Dysmenorrhoea With the OVA TENS Apparatus

Further study details as provided by The Hospital of Vestfold:

Primary Outcome Measures:
  • Change in VAS pain score

Estimated Enrollment: 20
Study Start Date: September 2005
Estimated Study Completion Date: May 2006
Detailed Description:

Study aims: To compare perception of dysmenorrhoea with and without use of OVA.

Design: Prospective, clinical study lasting four months. The women will use the OVA apparatus during every other menstruation.

Inclusion: 20 female volunteers with primary dysmenorrhoea.

Exclusion: Pregnancy, either ongoing or planned during the study period. Secondary dysmenorrhoea.

Consent: The participants will receive verbal and written information and will sign a consent form.

Randomisation: The participants are randomised to start with either active treatment or observation by drawing a closed, opaque envelope containing the forms for registration of perception of pain.

Registering pain: The participants will mark their perceived degree of dysmenorrhoea daily on 10 cm visual analogue scale (VAS) during each menstruation.

Filling in forms: During each of the four menstruations throughout the study period the participants will respond daily to the questions on the form and note degree of pain on the VAS. At the end of each menstruation they will mail the current form in a stamped and addressed envelope to the study coordinator.

Statistics: We assume that a difference of 2 VAS-points is required for an effect to be of clinical interest. One-sided t-test for paired data will be used in the analysis.

Power calculation using the statistics program SSD v7.0 has shown that 16 participants is required to demonstrate a difference of 2 points at level of significance p=0.01, 90% power and assumed standard deviation of 2.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Primary dysmenorrhoea

Exclusion Criteria:

  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00225836

Locations
Norway
Dept of Ob/Gyn, The Hospital of Vestfold
Tonsberg, Norway, N-3103
Sponsors and Collaborators
The Hospital of Vestfold
Vitacon AS, Vegamot 8, 7048 Trondheim, Norway
Investigators
Principal Investigator: Hjalmar A Schiotz, MD, PhD Consultant Gynecologist, The Hospital of Vestfold, Tonsberg, Norway
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00225836     History of Changes
Other Study ID Numbers: OVA study
Study First Received: September 22, 2005
Last Updated: January 12, 2007
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by The Hospital of Vestfold:
Dysmenorrhoea
Women
Pain
TENS

Additional relevant MeSH terms:
Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 01, 2014