DysmenorrhoeaNCT00225836
Treatment of Dysmenorrhoea With the OVA TENS Apparatus
A study testing OVA (TENS apparatus) in people with Dysmenorrhoea, run by The Hospital of Vestfold at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dysmenorrhoea
- What is being tested?
- OVA (TENS apparatus)
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2005to May 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Primary dysmenorrhoea
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Dysmenorrhoea
- Being tested
- OVA (TENS apparatus)
- Keywords
- Dysmenorrhoea, Women, Pain, TENS
- Medical subject headings
- Dysmenorrhea, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OVA (TENS apparatus)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in VAS pain score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2005 (estimated)
- Study startSep 2005
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysmenorrhoeaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- The Hospital of Vestfold
- Sponsor type
- University, hospital or other
- Collaborators
- Vitacon AS, Vegamot 8, 7048 Trondheim, Norway
- Investigators
- Hjalmar A Schiotz, MD, PhD, Principal investigator, Consultant Gynecologist, The Hospital of Vestfold, Tonsberg, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00225836
- Sponsor's protocol ID
- OVA study
- Status last verified
- Jan 2007
- First submitted
- 22 Sep 2005
- Last updated
- 17 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Dysmenorrhoea With the OVA TENS Apparatus
- ClinicalTrials.gov ID
- NCT00225836
- Acronym / sponsor ID
- OVA study
- Conditions
- Dysmenorrhoea
- Keywords
- Dysmenorrhoea, Women, Pain, TENS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- The Hospital of VestfoldUniversity, hospital or other
- Collaborators
- Vitacon AS, Vegamot 8, 7048 Trondheim, Norway
- Study start
- Sep 2005
- Study completion
- May 2006
- First posted
- 26 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Primary dysmenorrhoea
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OVA (TENS apparatus) | Device | – |
Primary outcome
Change in VAS pain score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hjalmar A Schiotz, MD, PhD principal investigator
Consultant Gynecologist, The Hospital of Vestfold, Tonsberg, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OVA (TENS apparatus) in people with Dysmenorrhoea, run by The Hospital of Vestfold at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in VAS pain score. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2007.