Clinical trial NCT03148223: Auriculotherapy in the Treatment of Dysmenorrhea
Official title: Effect of Auriculotherapy in the Treatment of Dysmenorrhea: Protocol of a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Dysmenorrhea
Keywords: Dysmenorrhea
acupuncture
auriculotherapy
Lead sponsor: University of Sorocaba
Sponsor class: OTHER
First posted: 2017-05-10
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to determine if auriculotherapy is effective in the treatment of dysmenorrhoea. This intervention consists of fixation of yellow mustard seeds at specific points of the auricular pavilion (or area), with opaque tape. Half of the participants will have specific ear pinch points stimulated by mustard seeds fixed with opaque plaster, while the other half will have only the adhesive plasters fixed, without the seeds for stimulation.

Detailed description: Primary dysmenorrhoea is responsible for the most part of dissatisfactions in the female class, in the face of discomforts which are caused monthly. For this, the income index of this woman in the work environment tends to reduce, thus harming the development of every sector to which she responds. The expected effects, after the intervention, will be positive, favoring a considerable improvement of the symptoms reported by the women. We chose auriculotherapy because it is a non-medicated, noninvasive intervention that is inexpensive.

Eligibility criteria: Inclusion Criteria:

* To be eligible to participate in this study, the individual must meet the following criteria:

  * Free and informed consent form, duly signed and dated
  * Consent to voluntarily participate in all study procedures and availability for the duration of the study
  * Female subjects
  * Age above of 18 years old
  * Enjoy good general health
  * Have active menstrual cycle
  * Complaint about dysmenorrhea

Exclusion Criteria:

* An individual who meets any of the following criteria will be excluded from participation in this study:

  * Clinical diagnosis of endometriosis
  * Myomas
  * Pelvic inflammatory disease
  * Adenomyosis
  * In the active phase for treatment of cancer (chemotherapy or radiotherapy)
  * Women who are already in menopause
  * Pregnancy

Primary outcomes:
measure: Measurement on pain perception
timeFrame: 12 weeks
Secondary outcomes:
measure: Welfare
timeFrame: 12 weeks
measure: Number of participants with adverse events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Sorocaba
country: Brazil
facility: Universidade de Sorocaba - Campus Cidade Universitária
state: São Paulo
Study officials:
affiliation: Universidade de Sorocaba
name: Luciane Cruz Lopes
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Dawood MY. Primary dysmenorrhea: advances in pathogenesis and management. Obstet Gynecol. 2006 Aug;108(2):428-41. doi: 10.1097/01.AOG.0000230214.26638.0c.
citation: Latthe P, Latthe M, Say L, Gulmezoglu M, Khan KS. WHO systematic review of prevalence of chronic pelvic pain: a neglected reproductive health morbidity. BMC Public Health. 2006 Jul 6;6:177. doi: 10.1186/1471-2458-6-177.
citation: Weissman AM, Hartz AJ, Hansen MD, Johnson SR. The natural history of primary dysmenorrhoea: a longitudinal study. BJOG. 2004 Apr;111(4):345-52. doi: 10.1111/j.1471-0528.2004.00090.x.
citation: Proctor M, Farquhar C. Diagnosis and management of dysmenorrhoea. BMJ. 2006 May 13;332(7550):1134-8. doi: 10.1136/bmj.332.7550.1134. No abstract available.
citation: Altman DG, Bland JM. How to randomise. BMJ. 1999 Sep 11;319(7211):703-4. doi: 10.1136/bmj.319.7211.703. No abstract available.
citation: Smith CA, Armour M, Zhu X, Li X, Lu ZY, Song J. Acupuncture for dysmenorrhoea. Cochrane Database Syst Rev. 2016 Apr 18;4(4):CD007854. doi: 10.1002/14651858.CD007854.pub3.
citation: Song JS, Liu YQ, Liu CZ, Xie JP, Ma LX, Wang LP, Zheng YY, Ma ZB, Yang H, Chen X, Shi GX, Li SL, Zhao JP, Han JX, Wang YX, Liu JP, Zhu J. [Cumulative analgesic effects of EA stimulation of sanyinjiao (SP 6) in primary dysmenorrhea patients: a multicenter randomized controlled clinical trial]. Zhen Ci Yan Jiu. 2013 Oct;38(5):393-8. Chinese.