Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2005-09-30
2006-05-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Interventions
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OVA (TENS apparatus)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
FEMALE
Yes
Sponsors
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Vitacon AS, Vegamot 8, 7048 Trondheim, Norway
UNKNOWN
The Hospital of Vestfold
OTHER
Principal Investigators
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Hjalmar A Schiotz, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Consultant Gynecologist, The Hospital of Vestfold, Tonsberg, Norway
Locations
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Dept of Ob/Gyn, The Hospital of Vestfold
Tønsberg, , Norway
Countries
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Other Identifiers
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OVA study
Identifier Type: -
Identifier Source: org_study_id
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