A Randomized, Sham Device Controlled, Single Blinded Trial of Portable Transcutaneous Electrical Nerve Stimulation and Heat Therapy Machine in Women With Dysmenorrhea

Seoul National University

Status and phase: Unknown; Phase 3

Conditions: Dysmenorrhea

Treatments: Device: sham; Device: I RUNE

Study type: Interventional

Funder types: Other

Identifiers

NCT01662934

SNUBH_GO_004

Details and patient eligibility

About

The hypothesis is that a transcutaneous electrical nerve stimulation and heat therapy machine could reduce dysmenorrhea in women with primary or secondary dysmenorrhea.

Full description

Inclusion/Exclusion: Described in Eligibility section. Outcome measures: Change of VAS score before and after use of TENS and heat therapy machine.

Enrollment: 118 estimated patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion

• Age>19
• Premenopausal
• Moderate or severe dysmenorrhea, mainly in low abdomen area

Exclusion

• Pregnant
• Surgery history on lower abdomen
• Recent history of cancer
• TENS device use is contraindicated
• Ibuprofen use is contraindicated

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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118 participants in 2 patient groups

Sham

Sham Comparator group

Description:

Using not functioning device

Treatment:

Device: sham

Experimental

Experimental group

Description:

Using functioning device

Treatment:

Device: I RUNE