The Efficacy of Two Types of Acupuncture on Autonomic Nervous Activity and Quality of Life in Women With Dysmenorrhea.

NCT04178226 | Unknown

• 1 other identifier: TCHIRB-10712112
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Integrative medicine raises public's attention due to either mainstream or traditional medicine has its limitation. The topic "dysmenorrhea", with prevalence up to 50%, troubled many females with symptom as depression, reduced the quality of life; and even withdraw from daily activity. Clinically, gynecologists apply analgesic such as Non-steroidal Anti-inflammatory Drugs, and oral contraceptive pills or progestin as conventional therapy. As NSAIDs cause gastrointestinal discomfort, while hormone therapy leads to other concerns; some women now adopt acupuncture as an alternative therapy for its safety. Furthermore, laser acupuncture has been practiced in recent years for it integrates the meridian theory and laser therapy; hence there are also some positive research in academic field.Whether laser or traditional acupuncture is more effective is still under debate. Additionally, investigators had published that the theory of yin/yang (meridian) is compatible with autonomic nerve theory. As many women with dysmenorrhea suffered from insomnia, anxiety, convulsion of the uterine muscle, which are related to autonomic nerve dysfunction, investigators are intrigued to know whether the effect of acupuncture is related to adjusting autonomic nerve system. Investigators intend to investigate the efficacy of laser and manual acupuncture in dysmenorrhea, and whether their mechanism is germane to hormone alternation or autonomic nervous system adjustment. The points in this proposal are 1.evaluate the efficacy of manual/laser acupuncture in dysmenorrhea in respects of symptoms and quality of life 2. compare whether these types acupuncture will alter the prostaglandin or hormone and the relationship between with the efficacy. 3. evaluate whether the mechanism of manual and laser acupuncture is relevant to alternating the autonomic nerve activity and if not correspond to Yin-Yang theory.

Conditions

Dysmenorrhea

Keywords

acupuncture; laser acupuncture; Autonomic nerve activity; dysmenorrhea; prostaglandin; quality of life

Outcome Measures

Primary Outcomes (2)

• The serum prostaglandin E2 level change.

  serum test

  baseline, after 3 months treatments, after 1 month wash out, after another 3 months treatments

• The autonomic nerve activity change.

  Heart rate variance equipment

  baseline, before and after every month treatment for 3 months, after 1 month wash out, before and after every month treatment for 3 months.ts

Secondary Outcomes (1)

• The quality of life change.

  baseline, after every month treatment for 3 months, after 1 month wash out, after every month treatment for 3 months.ts

Study Arms (3)

Control

NO INTERVENTION

conventional therapy (NSAIDs and OCP)

Manual Acupuncture

EXPERIMENTAL

manual acupuncture therpy

Other: Manual Acupuncture

Laser Acupuncture

EXPERIMENTAL

laser acupuncture therapy

Device: Laser Acupuncture

Interventions

Manual Acupuncture OTHER

The acupoints choose are (RN6) (RN4) (SP6) (PC6) (SP10) (SP4)

Manual Acupuncture

Laser Acupuncture DEVICE

The acupoints choose are (RN6) (RN4) (SP6) (PC6) (SP10) (SP4)

Laser Acupuncture

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Women within reproductive age (15 to 49 years);
• Participants who complain about dysmenorrhea with at least grade II level.
• Self-reported lower abdominal and pelvic, medial anterior thigh pain or low back pain associated with the onset of menses and lasting in 72 hours.
• Some accompanied symptoms as dizziness and syncope, cramping, nausea, vomiting, diarrhea, headaches, and fatigue present compatible with the menses cycle were also included.

You may not qualify if:

• Dysmenorrhea resulting from the use of an intra-uterine device (IUD);
• Mild or infrequent dysmenorrhea.
• Dysmenorrhea with possible underlying tumor or malignancy

Sponsors & Collaborators

• Taipei City Hospital: lead

Study Sites (1)

Taipei City Hospital

Taipei, 111, Taiwan

RECRUITING

Related Publications (20)

• Iacovides S, Avidon I, Bentley A, Baker FC. Reduced quality of life when experiencing menstrual pain in women with primary dysmenorrhea. Acta Obstet Gynecol Scand. 2014 Feb;93(2):213-7. doi: 10.1111/aogs.12287. Epub 2013 Nov 25.

  PMID: 24266425 BACKGROUND

• Bernardi M, Lazzeri L, Perelli F, Reis FM, Petraglia F. Dysmenorrhea and related disorders. F1000Res. 2017 Sep 5;6:1645. doi: 10.12688/f1000research.11682.1. eCollection 2017.

  PMID: 28944048 BACKGROUND

• Hasegawa N. [Dysmenorrhea and the autonomic nervous system]. Sanfujinka No Jissai. 1968 Jun;17(6):492-8. No abstract available. Japanese.

  PMID: 5755245 BACKGROUND

• Osayande AS, Mehulic S. Diagnosis and initial management of dysmenorrhea. Am Fam Physician. 2014 Mar 1;89(5):341-6.

  PMID: 24695505 BACKGROUND

• Smith CA, Zhu X, He L, Song J. Acupuncture for primary dysmenorrhoea. Cochrane Database Syst Rev. 2011 Jan 19;(1):CD007854. doi: 10.1002/14651858.CD007854.pub2.

  PMID: 21249697 RESULT

• Taguchi R. Acupuncture anesthesia and analgesia for clinical acute pain in Japan. Evid Based Complement Alternat Med. 2008 Jun;5(2):153-8. doi: 10.1093/ecam/nem056.

  PMID: 18604250 RESULT

• McDonald JL, Cripps AW, Smith PK. Mediators, Receptors, and Signalling Pathways in the Anti-Inflammatory and Antihyperalgesic Effects of Acupuncture. Evid Based Complement Alternat Med. 2015;2015:975632. doi: 10.1155/2015/975632. Epub 2015 Aug 3.

  PMID: 26339274 RESULT

• Stener-Victorin E, Waldenstrom U, Andersson SA, Wikland M. Reduction of blood flow impedance in the uterine arteries of infertile women with electro-acupuncture. Hum Reprod. 1996 Jun;11(6):1314-7. doi: 10.1093/oxfordjournals.humrep.a019378.

  PMID: 8671446 RESULT

• Witt CM, Reinhold T, Brinkhaus B, Roll S, Jena S, Willich SN. Acupuncture in patients with dysmenorrhea: a randomized study on clinical effectiveness and cost-effectiveness in usual care. Am J Obstet Gynecol. 2008 Feb;198(2):166.e1-8. doi: 10.1016/j.ajog.2007.07.041.

  PMID: 18226614 RESULT

• Kempf D, Berger D, Ausfeld-Hafter B. [Laser needle acupuncture in women with dysmenorrhoea: a randomised controlled double blind pilot trial]. Forsch Komplementmed. 2009 Feb;16(1):6-12. doi: 10.1159/000193294. Epub 2009 Feb 4. German.

  PMID: 19295224 RESULT

• Shu Q, Wang H, Litscher D, Wu S, Chen L, Gaischek I, Wang L, He W, Zhou H, Litscher G, Liang F. Acupuncture and Moxibustion have Different Effects on Fatigue by Regulating the Autonomic Nervous System: A Pilot Controlled Clinical Trial. Sci Rep. 2016 Nov 25;6:37846. doi: 10.1038/srep37846.

  PMID: 27886247 RESULT

• Wu JH, Chen HY, Chang YJ, Wu HC, Chang WD, Chu YJ, Jiang JA. Study of autonomic nervous activity of night shift workers treated with laser acupuncture. Photomed Laser Surg. 2009 Apr;27(2):273-9. doi: 10.1089/pho.2007.2235.

  PMID: 18785846 RESULT

• Wong YM. Effect of Laser Acupuncture on Heart Rate Variability of Nonpatients and Patients with Spinal Cord Injury. J Acupunct Meridian Stud. 2017 Jan;10(1):53-54. doi: 10.1016/j.jams.2016.11.004. Epub 2016 Nov 29.

  PMID: 28254104 RESULT

• Chien LW, Chen FC, Hu HY, Liu CF. Correlation of electrical conductance in meridian and autonomic nervous activity after auricular acupressure in middle-aged women. J Altern Complement Med. 2014 Aug;20(8):635-41. doi: 10.1089/acm.2012.0900. Epub 2014 May 27.

  PMID: 24865945 RESULT

• Litscher G. Bioengineering assessment of acupuncture, Part 6: monitoring--neurophysiology. Crit Rev Biomed Eng. 2007;35(1-2):1-36. doi: 10.1615/critrevbiomedeng.v35.i1-2.10.

  PMID: 17956221 RESULT

• Schmidt K. [Should acupuncture be reimbursable? Yin and yang in significant conflict]. MMW Fortschr Med. 2000 Aug 24;142(33-34):52. No abstract available. German.

  PMID: 10998908 RESULT

• Larroy C. Comparing visual-analog and numeric scales for assessing menstrual pain. Behav Med. 2002 Winter;27(4):179-81. doi: 10.1080/08964280209596043.

  PMID: 12165972 RESULT

• Gandek B, Ware JE, Aaronson NK, Apolone G, Bjorner JB, Brazier JE, Bullinger M, Kaasa S, Leplege A, Prieto L, Sullivan M. Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol. 1998 Nov;51(11):1171-8. doi: 10.1016/s0895-4356(98)00109-7.

  PMID: 9817135 RESULT

• Chien TJ, Chang YI, Liao LL, Hsu YN, Huang CW. Comparative Efficacy of Low-Level Laser Acupuncture and Electroacupuncture in Women With Dysmenorrhea and Autonomic Imbalance: A Pilot Randomized-Controlled Trial. Pain Res Manag. 2025 Oct 23;2025:3494216. doi: 10.1155/prm/3494216. eCollection 2025.

  PMID: 41179650 DERIVED

• Chien TJ, Huang YS, Liao LL, Chu CC, Pai JH. Head-to-Head Comparison of Electroacupuncture and Laser Acupuncture Effects on Autonomic Regulation and Clinical Effects in Dysmenorrhea: A Randomized Crossover Clinical Trial. J Integr Complement Med. 2024 Jun;30(6):560-575. doi: 10.1089/jicm.2023.0183. Epub 2024 Feb 16.

  PMID: 38364185 DERIVED

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

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

Study Officials

• Tsai-Ju Chien, PhD

  Taipei City Hospital

  STUDY CHAIR

Central Study Contacts

Tsai-Ju Chien, PhD

CONTACT

+886979305521; silence021@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 1. Control group 2. Acupuncture group 3. Laser acupuncture group Patients in acupuncture/ laser acupuncture group will be crossover to another group after 3 courses of treatment.

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: November 26, 2019
• Study Start: August 15, 2019
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: May 25, 2021

Record last verified: 2021-05

Locations

TW (1)