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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00225836
Other study ID # OVA study
Secondary ID
Status Completed
Phase N/A
First received September 22, 2005
Last updated January 12, 2007
Start date September 2005
Est. completion date May 2006

Study information

Verified date January 2007
Source The Hospital of Vestfold
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date May 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- Primary dysmenorrhoea

Exclusion Criteria:

- Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Device:
OVA (TENS apparatus)


Locations

Country Name City State
Norway Dept of Ob/Gyn, The Hospital of Vestfold Tonsberg

Sponsors (2)

Lead Sponsor Collaborator
The Hospital of Vestfold Vitacon AS, Vegamot 8, 7048 Trondheim, Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in VAS pain score
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02636972 - The Progression From Dysmenorrhoea to Chronic Pelvic Pain N/A
Completed NCT04618172 - Effects of Exercise on the Symptoms of Premenstrual Syndrome and Dysmenorrhoea and Blood Flow of Genital Tract N/A