A Randomized, Sham Device Controlled, Single Blinded Trial of Portable Transcutaneous Electrical Nerve Stimulation and Heat Therapy Machine in Women With Dysmenorrhea
1 other identifier
interventional
118
1 country
1
Brief Summary
The hypothesis is that a transcutaneous electrical nerve stimulation and heat therapy machine could reduce dysmenorrhea in women with primary or secondary dysmenorrhea.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2012
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 7, 2012
CompletedFirst Posted
Study publicly available on registry
August 13, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedMarch 15, 2013
March 1, 2013
8 months
August 7, 2012
March 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Immediately before application of machine and 20minutes after application of machine
Secondary Outcomes (1)
BPI score
2nd day of menstrual cycle
Study Arms (2)
Sham
SHAM COMPARATORUsing not functioning device
Experimental
EXPERIMENTALUsing functioning device
Interventions
Eligibility Criteria
You may qualify if:
- Age\>19
- Premenopausal
- Moderate or severe dysmenorrhea, mainly in low abdomen area
You may not qualify if:
- Pregnant
- Surgery history on lower abdomen
- Recent history of cancer
- TENS device use is contraindicated
- Ibuprofen use is contraindicated
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam-si, Gyenggi Do, 463707, South Korea
Related Publications (1)
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.
PMID: 26340453DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2012
First Posted
August 13, 2012
Study Start
August 1, 2012
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
March 15, 2013
Record last verified: 2013-03