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Treatment of Dysmenorrhoea With the OVA TENS Apparatus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00225836
Recruitment Status : Completed
First Posted : September 26, 2005
Last Update Posted : January 17, 2007
Vitacon AS, Vegamot 8, 7048 Trondheim, Norway
Information provided by:
The Hospital of Vestfold

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.

Condition or disease Intervention/treatment Phase
Dysmenorrhoea Device: OVA (TENS apparatus) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Dysmenorrhoea With the OVA TENS Apparatus
Study Start Date : September 2005
Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Period Pain

Primary Outcome Measures :
  1. Change in VAS pain score

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Primary dysmenorrhoea

Exclusion Criteria:

  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00225836

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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
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Principal Investigator: Hjalmar A Schiotz, MD, PhD Consultant Gynecologist, The Hospital of Vestfold, Tonsberg, Norway

Layout table for additonal information Identifier: NCT00225836    
Other Study ID Numbers: OVA study
First Posted: September 26, 2005    Key Record Dates
Last Update Posted: January 17, 2007
Last Verified: January 2007
Keywords provided by The Hospital of Vestfold:
Additional relevant MeSH terms:
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Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Neurologic Manifestations
Signs and Symptoms