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Auriculotherapy in the Treatment of Dysmenorrhea

Primary Purpose

Primary Dysmenorrhea

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

auriculotherapy

About this trial

This is an interventional treatment trial for Primary Dysmenorrhea focused on measuring Dysmenorrhea, acupuncture, auriculotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Universidade de Sorocaba - Campus Cidade Universitária

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Number of participants with adverse events

Adverse events will be collected spontaneously by the active survey, at all visits of participants.

Full Information

NCT ID

NCT03148223

First Posted

May 8, 2017

Last Updated

October 19, 2018

Sponsor

University of Sorocaba

1. Study Identification

Unique Protocol Identification Number

NCT03148223

Brief Title

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

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

May 15, 2017 (Actual)

Primary Completion Date

August 30, 2018 (Actual)

Study Completion Date

October 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Sorocaba

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Dysmenorrhea

Keywords

Dysmenorrhea, acupuncture, auriculotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

Participants will not be informed which group they belong to, intervention or control. Who will apply the treatment will not be blind, since during the treatment it will know if the points to be stimulated must contain seeds of mustard or just plaster, but will not have previous knowledge of the members of the groups. The evaluator, who is responsible for applying the pre- and post-treatment evaluation instruments, will be blind and not aware of the research intervention. The data analyst will also be early for the intervention group.

Allocation

Randomized

Enrollment

74 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

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.

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

auriculotherapy

Other Intervention Name(s)

acupuncture

Intervention Description

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.

Primary Outcome Measure Information:

Title

Measurement on pain perception

Description

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Welfare

Description

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.

Time Frame

12 weeks

Title

Number of participants with adverse events

Description

Adverse events will be collected spontaneously by the active survey, at all visits of participants.

Time Frame

12 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Luciane Cruz Lopes

Organizational Affiliation

Universidade de Sorocaba

Official's Role

Principal Investigator

Facility Information:

Facility Name

Universidade de Sorocaba - Campus Cidade Universitária

City

Sorocaba

State/Province

São Paulo

ZIP/Postal Code

18023-000

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

We intend to share the data six months after the conclusion of the study

IPD Sharing Time Frame

Data will be available since the study were published.

IPD Sharing Access Criteria

Data access requests should be made via an application form detailing the specific requirements and the proposed research and publication plan. Any request access will be controlled to types of data analyses, process for requesting data/documents. We will discuss with the team of researcher the "quality of request".

IPD Sharing URL

http://www.uniso.br

Citations:

PubMed Identifier

15161896

Citation

Chan AW, Hrobjartsson A, Haahr MT, Gotzsche 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. doi: 10.1001/jama.291.20.2457.

Results Reference

background

PubMed Identifier

16880317

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.

Results Reference

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PubMed Identifier

16824213

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.

Results Reference

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PubMed Identifier

15008771

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.

Results Reference

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PubMed Identifier

16690671

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.

Results Reference

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PubMed Identifier

10480833

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.

Results Reference

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PubMed Identifier

27087494

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.

Results Reference

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PubMed Identifier

24308187

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.

Results Reference

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Auriculotherapy in the Treatment of Dysmenorrhea

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