Auriculotherapy in the Treatment of Dysmenorrhea

Primary Dysmenorrhea Clinical Trial

Official title:

Effect of Auriculotherapy in the Treatment of Dysmenorrhea: Protocol of a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03148223
• Other study ID #: 45269015.3.0000.5500
• Status: Completed
• Phase: N/A
• Start date: May 15, 2017
• Est. completion date: October 15, 2018

Study information

• Verified date: October 2018
• Source: University of Sorocaba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: October 15, 2018
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhea

Intervention

Device:
• auriculotherapy
The participants will be submitted to a session per week with duration of 20 minutes, for three consecutive months, to fix the adhesives. The points selected for stimulation, according to Chinese atrial mapping, are: uterus, endocrine, ovary, pituitary, shen men, sympathetic, and liver. Participants will be advised to remain with the stickers fixed to the auricle for six days.

Locations

Country	Name	City	State
Brazil	Universidade de Sorocaba - Campus Cidade Universitária	Sorocaba	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sorocaba

Country where clinical trial is conducted

Brazil, 

References & Publications (8)

Altman DG, Bland JM. How to randomise. BMJ. 1999 Sep 11;319(7211):703-4. Review. — View Citation

Chan AW, Hróbjartsson A, Haahr MT, Gøtzsche PC, Altman DG. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA. 2004 May 26;291(20):2457-65. — View Citation

Dawood MY. Primary dysmenorrhea: advances in pathogenesis and management. Obstet Gynecol. 2006 Aug;108(2):428-41. Review. — View Citation

Latthe P, Latthe M, Say L, Gülmezoglu 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. Review. — View Citation

Proctor M, Farquhar C. Diagnosis and management of dysmenorrhoea. BMJ. 2006 May 13;332(7550):1134-8. Review. — View Citation

Smith CA, Armour M, Zhu X, Li X, Lu ZY, Song J. Acupuncture for dysmenorrhoea. Cochrane Database Syst Rev. 2016 Apr 18;4:CD007854. doi: 10.1002/14651858.CD007854.pub3. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement on pain perception	The numerical visual scale of pain 0-10 (0 = no pain, 10 = worst possible pain), applied at the beginning of the intervention period and reapplied to each menstrual period during the 12 weeks of follow-up will be used.	12 weeks
Secondary	Welfare	The quality of life questionnaire (Short-Form Health Survey SF36) will be applied at the beginning of the intervention period and reapplied at the end of the 12 weeks of intervention.	12 weeks
Secondary	Number of participants with adverse events	Adverse events will be collected spontaneously by the active survey, at all visits of participants.	12 weeks