Auriculotherapy in the Treatment of Dysmenorrhea
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention Auriculotherapy with application of mustard seeds fixed with adhesive tape at specific points in the auricle during one session per week lasting 20 minutes for 3 consecutive months. |
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.
Other Names:
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| Placebo Comparator: Control Auriculotherapy with tape-only fixation in the auricle, without mustard seeds, following the same stitch protocol used with the intervention group, during a session per week lasting 20 minutes, for three consecutive months. |
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Measurement on pain perception [12 weeks]
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.
Secondary Outcome Measures
- Welfare [12 weeks]
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.
- Number of participants with adverse events [12 weeks]
Adverse events will be collected spontaneously by the active survey, at all visits of participants.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
To be eligible to participate in this study, the individual must meet the following criteria:
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Free and informed consent form, duly signed and dated
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Consent to voluntarily participate in all study procedures and availability for the duration of the study
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Female subjects
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Age above of 18 years old
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Enjoy good general health
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Have active menstrual cycle
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Complaint about dysmenorrhea
Exclusion Criteria:
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An individual who meets any of the following criteria will be excluded from participation in this study:
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Clinical diagnosis of endometriosis
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Myomas
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Pelvic inflammatory disease
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Adenomyosis
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In the active phase for treatment of cancer (chemotherapy or radiotherapy)
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Women who are already in menopause
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Pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universidade de Sorocaba - Campus Cidade Universitária | Sorocaba | São Paulo | Brazil | 18023-000 |
Sponsors and Collaborators
- University of Sorocaba
Investigators
- Principal Investigator: Luciane Cruz Lopes, Universidade de Sorocaba
Study Documents (Full-Text)
None provided.More Information
Publications
- Altman DG, Bland JM. How to randomise. BMJ. 1999 Sep 11;319(7211):703-4. Review.
- 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.
- Dawood MY. Primary dysmenorrhea: advances in pathogenesis and management. Obstet Gynecol. 2006 Aug;108(2):428-41. Review.
- 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.
- Proctor M, Farquhar C. Diagnosis and management of dysmenorrhoea. BMJ. 2006 May 13;332(7550):1134-8. Review.
- 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.
- 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.
- Weissman AM, Hartz AJ, Hansen MD, Johnson SR. The natural history of primary dysmenorrhoea: a longitudinal study. BJOG. 2004 Apr;111(4):345-52.
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