DysmenorrheaPhase 3NCT01662934
A Randomized, Sham Device Controlled, Single Blinded Trial of Portable Transcutaneous Electrical Nerve Stimulation and Heat Therapy Machine in Women With Dysmenorrhea
A Phase 3 study testing I RUNE in people with Dysmenorrhea, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The hypothesis is that a transcutaneous electrical nerve stimulation and heat therapy machine could reduce dysmenorrhea in women with primary or secondary dysmenorrhea. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- I RUNE
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2012to Apr 2013
- Phase
- Phase 3
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>19
- Premenopausal
- Moderate or severe dysmenorrhea, mainly in low abdomen area
Who cannot join
- Pregnant
- Surgery history on lower abdomen
- Recent history of cancer
- TENS device use is contraindicated
- Ibuprofen use is contraindicated
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyenggi Do, 463707
About this study
The hypothesis is that a transcutaneous electrical nerve stimulation and heat therapy machine could reduce dysmenorrhea in women with primary or secondary dysmenorrhea.
Read the detailed description
Inclusion/Exclusion: Described in Eligibility section. Outcome measures: Change of VAS score before and after use of TENS and heat therapy machine.
- Conditions
- Dysmenorrhea
- Being tested
- I RUNE, sham
- Keywords
- dysmenorrhea, transcutaneous electrical nerve stimulation, heat therapy
- Medical subject headings
- Dysmenorrhea, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I RUNEDevice
Also called Transcutaneous electrical nerve stimulation and heat therapy machine
shamDevice
Also called sham device
| Study group | Role | What they receive |
|---|---|---|
| Sham | Sham comparator | Using not functioning device Receives: Device: sham |
| Experimental | Experimental | Using functioning device Receives: Device: I RUNE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of VAS before and after application of machine
Measure the change% of VAS between before application of machine (T0) and 20 minutes after application of machine (T20) in every episode of dysmenorrhea during 1 menstrual cycle The mean of change% of VAS is primary outcome measure
Measured: Immediately before application of machine and 20minutes after application of machine
Secondary outcomes (1)
BPI score
Brief Pain Inventory score
Measured: 2nd day of menstrual cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionApr 2013 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01662934
- Sponsor's protocol ID
- SNUBH_GO_004
- Status last verified
- Mar 2013
- First submitted
- 7 Aug 2012
- Last updated
- 15 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lee B, Hong SH, Kim K, Kang WC, No JH, Lee JR, Jee BC, Yang EJ, Cha EJ, Kim YB. Efficacy of the device combining high-frequency transcutaneous electrical nerve stimulation and thermotherapy for relieving primary dysmenorrhea: a randomized, single-blind, placebo-controlled trial. Eur J Obstet Gynecol Reprod Biol. 2015 Nov;194:58-63. doi: 10.1016/j.ejogrb.2015.08.020. Epub 2015 Aug 22.
PubMed 26340453
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Sham Device Controlled, Single Blinded Trial of Portable Transcutaneous Electrical Nerve Stimulation and Heat Therapy Machine in Women With Dysmenorrhea
- ClinicalTrials.gov ID
- NCT01662934
- Acronym / sponsor ID
- SNUBH_GO_004
- Conditions
- Dysmenorrhea
- Keywords
- dysmenorrhea, transcutaneous electrical nerve stimulation, heat therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 13 Aug 2012 (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.
The hypothesis is that a transcutaneous electrical nerve stimulation and heat therapy machine could reduce dysmenorrhea in women with primary or secondary dysmenorrhea.
Detailed description
Inclusion/Exclusion: Described in Eligibility section. Outcome measures: Change of VAS score before and after use of TENS and heat therapy machine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham | Sham comparator | Device: shamUsing not functioning device |
| Experimental | Experimental | Device: I RUNEUsing functioning device |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age>19
- Premenopausal
- Moderate or severe dysmenorrhea, mainly in low abdomen area
Key exclusion criteria (5 listed)
- Pregnant
- Surgery history on lower abdomen
- Recent history of cancer
- TENS device use is contraindicated
- Ibuprofen use is contraindicated
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 |
|---|---|---|
| I RUNEAlso: Transcutaneous electrical nerve stimulation and heat therapy machine | Device | Experimental |
| shamAlso: sham device | Device | Sham |
Primary outcome
Change of VAS before and after application of machine
Time frame: Immediately before application of machine and 20minutes after application of machine
Measure the change% of VAS between before application of machine (T0) and 20 minutes after application of machine (T20) in every episode of dysmenorrhea during 1 menstrual cycle The mean of change% of VAS is primary outcome measure
1 secondary outcome
BPI score
Time frame: 2nd day of menstrual cycle
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2013.
- Derived from this study: PubMed 26340453Lee B, Hong SH, Kim K, Kang WC, No JH, Lee JR, Jee BC, Yang EJ, Cha EJ, Kim YB. Efficacy of the device combining high-frequency transcutaneous electrical nerve stimulation and thermotherapy for relieving primary dysmenorrhea: a randomized, single-blind, placebo-controlled trial. Eur J Obstet Gynecol Reprod Biol. 2015 Nov;194:58-63. doi: 10.1016/j.ejogrb.2015.08.020. Epub 2015 Aug 22.
Related trials for Dysmenorrhea
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
Active, not recruiting
Mindfulness-Based Education For Women With Polycystic Ovary Syndrome
Polycystic Ovary Syndrome (PCOS), Menstrual Symptoms
Not yet recruiting
The Effect of a Ginger Formula on Menstrual Health vs a Placebo
Painful Menstruation
Active, not recruitingPhase 2
A Phase 2 Trial to Investigate Efficacy and Safety of Vipoglanstat in Women With Endometriosis
Endometriosis
Not yet recruiting
Transcutaneous Cervical Vagus Nerve Stimulation for Primary Dysmenorrhea
Primary Dysmenorrhea (PD), Menstrual Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing I RUNE in people with Dysmenorrhea, run by Seoul National University Hospital at 1 site in South Korea.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 15 Mar 2013. 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 South Korea. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 of VAS before and after application of machine (time frame: Immediately before application of machine and 20minutes after application of machine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01662934, which also lists 1 linked publication.
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 15 Mar 2013.