Auriculotherapy in the Treatment of Dysmenorrhea

NCT03148223 | Completed DMC

• 1 other identifier: 45269015.3.0000.5500
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Dysmenorrhea

Keywords

Dysmenorrhea; acupuncture; auriculotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Welfare

  12 weeks

• Number of participants with adverse events

  12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Interventions

auriculotherapy DEVICE

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.

Also known as: acupuncture

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sorocaba: lead

Study Sites (1)

Universidade de Sorocaba - Campus Cidade Universitária

Sorocaba, São Paulo, 18023-000, Brazil

Location

Related Publications (8)

• 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.

  PMID: 15161896 BACKGROUND

• 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.

  PMID: 16880317 BACKGROUND

• 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.

  PMID: 16824213 BACKGROUND

• 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.

  PMID: 15008771 BACKGROUND

• 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.

  PMID: 16690671 BACKGROUND

• 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.

  PMID: 10480833 BACKGROUND

• 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.

  PMID: 27087494 BACKGROUND

• 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.

  PMID: 24308187 BACKGROUND

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Auriculotherapy; Acupuncture Therapy

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Luciane Cruz Lopes

  Universidade de Sorocaba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Responsible researcher

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 10, 2017
• Study Start: May 15, 2017
• Primary Completion: August 30, 2018
• Study Completion: October 15, 2018
• Last Updated: October 23, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available since the study were published.
• 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".

Locations

BR (1)