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The Comparison of Efficacy of Manual Acupuncture and Laser Acupuncture on Autonomic Nervous Activity and Quality of Life in Women With Dysmenorrhea.

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ClinicalTrials.gov Identifier: NCT04178226
Recruitment Status : Recruiting
First Posted : November 26, 2019
Last Update Posted : November 26, 2019
Sponsor:
Information provided by (Responsible Party):
Taipei City Hospital

Brief Summary:

Integrative medicine raises public's attention due to either mainstream or traditional medicine has its limitation. Therefore, more and more people are willing to adopt integrative in dealing with uncontrollable symptom or disease.

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.

Generally speaking, primary dysmenorrhea is a menstrual pain in the absence of pelvic pathology while secondary dysmenorrhea is caused by organic dysfunction such as endometriosis, uterus malformation, inflammation, etc. 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. According to the theory of Traditional Chinese Medicine, acupuncture regulates meridians' energy whereas the western medicine reveals that the mechanism of pain-control of acupuncture is relevant to neurophysiologic and neuroendocrine adjustment.

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. The acceptability of laser acupuncture is much higher than traditional acupuncture for its non-invasiveness and could also be practiced by both TCM and western medicine physicians in clinics.

Nevertheless, 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.

(Aim) 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. 4. Determine whether acupuncture will have maintained effect.

(Method) A three-years, three arms, randomized, controlled, cross-over study will be performed to compare the control group, manual and laser acupuncture group. Primary outcome measurements include HRV parameters, and serum prostaglandins, estrogen, progesterone in different phases; second outcome measurements are VAS, VMSS (dysmenorrhea symptom) score analysis and SF12 quality of life assessment in three phases. Investigators expect this multidiscipline study could encourage more talk between in TCM and mainstream medicine and coordinate the different viewpoints. The study will provide physicians with the evidence about manual and laser acupuncture in dysmenorrhea.


Condition or disease Intervention/treatment Phase
Dysmenorrhea Procedure: Manual Acupuncture Device: Laser Acupuncture Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
  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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Comparison of Efficacy of Manual Acupuncture and Laser Acupuncture on Autonomic Nervous Activity and Quality of Life in Women With Dysmenorrhea.
Actual Study Start Date : August 15, 2019
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
conventional therapy (NSAIDs and OCP)
Experimental: Manual Acupuncture
manual acupuncture therpy
Procedure: Manual Acupuncture
The acupoints choose are (RN6) (RN4) (SP6) (PC6) (SP10) (SP4)
Other Name: Laser acupuncture

Experimental: Laser Acupuncture
laser acupuncture therapy
Device: Laser Acupuncture
Laser Acupuncture




Primary Outcome Measures :
  1. The serum prostaglandin E2 level change. [ Time Frame: baseline, after 3 months treatments, after 1 month wash out, after another 3 months treatments ]
    serum test

  2. The autonomic nerve activity change. [ Time Frame: 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 ]
    Heart rate variance equipment


Secondary Outcome Measures :
  1. The quality of life change. [ Time Frame: baseline, after every month treatment for 3 months, after 1 month wash out, after every month treatment for 3 months.ts ]
    SF-12 quality of life questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women within reproductive age (15 to 49 years);
  2. Participants who complain about dysmenorrhea with at least grade II level.
  3. 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.
  4. Some accompanied symptoms as dizziness and syncope, cramping, nausea, vomiting, diarrhea, headaches, and fatigue present compatible with the menses cycle were also included.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04178226


Contacts
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Contact: Tsai-Ju Chien, PhD +886979305521 silence021@gmail.com

Locations
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Taiwan
Taipei City Hospital Recruiting
Taipei, Taiwan, 111
Contact: Yi-Shuo Huang, BS    +886979308958    DAT72@tpech.gov.tw   
Sponsors and Collaborators
Taipei City Hospital
Investigators
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Study Chair: Tsai-Ju Chien, PhD Taipei City Hospital

Publications of Results:

Other Publications:
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Responsible Party: Taipei City Hospital
ClinicalTrials.gov Identifier: NCT04178226     History of Changes
Other Study ID Numbers: TCHIRB-10712112
First Posted: November 26, 2019    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taipei City Hospital:
acupuncture
laser acupuncture
Autonomic nerve activity
dysmenorrhea
prostaglandin
quality of life
Additional relevant MeSH terms:
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Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms