Clinical Trial: Treatment of Dysmenorrhoea With the OVA TENS Apparatus
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Treatment of Dysmenorrhoea With the OVA TENS Apparatus
Brief Summary:
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.
Detailed Summary:
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
Sponsor: The Hospital of Vestfold
Current Primary Outcome: Change in VAS pain score
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: The Hospital of Vestfold
Dates:
Date Received: September 22, 2005
Date Started: September 2005
Date Completion: May 2006
Last Updated: January 12, 2007
Last Verified: January 2007
