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Treatment of Dysmenorrhoea With the OVA TENS Apparatus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00225836
First Posted: September 26, 2005
Last Update Posted: October 12, 2017
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.
Collaborator:
Vitacon AS, Vegamot 8, 7048 Trondheim, Norway
Information provided by:
The Hospital of Vestfold
  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
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Dysmenorrhoea With the OVA TENS Apparatus

Resource links provided by NLM:


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

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Primary dysmenorrhoea

Exclusion Criteria:

  • Pregnancy
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00225836     History of Changes
Other Study ID Numbers: OVA study
First Submitted: September 22, 2005
First Posted: September 26, 2005
Last Update Posted: October 12, 2017
Last Verified: January 2007

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

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