Effect of MA Versus TENS for Primary Dysmenorrhea

NCT03977519 | Unknown

• 1 other identifier: 2018-176-KY
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The trial aims to evaluate the effect of manual acupuncture versus transcutaneous electric nerve stimulation in treating primary dysmenorrhea.

Conditions

Primary Dysmenorrhea

Keywords

primary dysmenorrhea; manual acupuncture; transcutaneous electric nerve stimulation; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• The proportion of patients with at least 50% reduction in mean pain intensity from baseline.

  The pain intensity was measured by the Numerical Rating Scale (NRS), which is a valid measure of pain intensity with scores from 0 (no pain) to 10 (worst possible pain).Participants will be asked to rate their mean pain intensity on the days with pain during the third menstruation by selecting a single number from 0 to 10.The primary outcome is the proportion of patients with at least 50% reduction in mean pain intensity from baseline.

  Baseline；At the end of menstrual period of Cycle 3(each menstrual period is about 3-7 days,each cycle is about 28 days)

Secondary Outcomes (5)

• Change of mean pain intensity from baseline measured by NRS.

  Baseline；At the end of menstrual period of Cycle 1,Cycle 2,Cycle 3 and Cycle 6(each menstrual period is about 3-7 days,each cycle is about 28 days)

• Change of the most severe pain intensity measured by NRS.

  Baseline；At the end of menstrual period of Cycle 1,Cycle 2,Cycle 3 and Cycle 6(each menstrual period is about 3-7 days,each cycle is about 28 days)

• Change of Cox Menstrual Symptom Scale(CMSS)

  Baseline；At the end of menstrual period of Cycle 1,Cycle 2,Cycle 3 and Cycle 6(each menstrual period is about 3-7 days,each cycle is about 28 days)

• Change of sick leave from baseline

  Baseline；At the end of menstrual period of Cycle 1,Cycle 2,Cycle 3 and Cycle 6(each menstrual period is about 3-7 days,each cycle is about 28 days)

• Change of pain duration from baseline

  Baseline；At the end of menstrual period of Cycle 1,Cycle 2,Cycle 3 and Cycle 6(each menstrual period is about 3-7 days,each cycle is about 28 days)

Other Outcomes (2)

• Pain medication intake

  At the end of menstrual period of Cycle 1,Cycle 2,Cycle 3 and Cycle 6(each menstrual period is about 3-7 days,each cycle is about 28 days)

• Patients' satisfaction towards treatment.

  At the end of menstrual period of Cycle 3 and Cycle 6(each menstrual period is about 3-7 days,each cycle is about 28 days)

Study Arms (2)

MA group

EXPERIMENTAL

Huatuo Brand needles (0.30×25mm,0.30×40mm or 0.30×75mm) will be used at EX-B8,BL32,SP8,and SP6.

Procedure: MA

TENS group

ACTIVE COMPARATOR

Huatuo Brand electrode patch (50mm×50mm) and the SDZ-V EA apparatus (Suzhou Medical Appliance) will be used to stimulate the area along the lower borders of the ribs and the upper borders of the hip crests on both sides.The parameters of the electric acupuncture apparatus：Continuous wave,the frequency is 100Hz, the current intensity is 2.5mA-5mA.

Procedure: TENS

Interventions

MA PROCEDURE

Huatuo Brand needles (0.30×25mm,0.30×40mm or 0.30×75mm) will be used.Participants will receive manual acupuncture for 30 minutes each time.After acupuncture,we will twist the needles every 10 minutes for about 30 seconds.The patients will be treated in their first day of dysmenorrhea, once a day for three consecutive days. And the treatments will last for three consecutive menstrual cycles.

MA group

TENS PROCEDURE

Huatuo Brand electrode patch (50mm×50mm) and the SDZ-V EA apparatus (Suzhou Medical Appliance) will be used.Participants will receive transcutaneous electric nerve stimulation for 30 minutes each time.They will be treated in their first day of dysmenorrhea, once a day for three consecutive days. And the treatments will last for three consecutive menstrual cycles.

TENS group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female;
• Aged of 18 to 40 years;
• Conforming to the criteria for the diagnosis of primary dysmenorrhea in the guideline developed by Society of Obstetricians and Gynaecologists of Canada（SOGC）in 2017.
• With normal menstrual cycle(28±7 days) and normal menstrual period（3-7days）；
• Menstrual mean pain score ≥4 on the numerical rating scale (NRS)；
• To sign the informed consent and participate in the study voluntarily.

You may not qualify if:

• Secondary dysmenorrhea;
• Pregnant patients,lactating patients or patients preparing pregnancy.
• Subjects with serious heart, liver, kidney damage or cognitive impairment, aphasia, mental disorders, or the inability to cooperate with the examination and treatment;
• Subjects with coagulation dysfunction or anticoagulants such as warfarin and heparin have been used all the time;
• Subjects installed with the cardiac pacemaker;
• Those who have received relevant acupuncture, transcutaneous electric nerve stimulation and other treatment (except pain medication) the last three months;
• Patients who may be allergic to electrodes.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100053, China

RECRUITING

Related Publications (4)

• Burnett M, Lemyre M. No. 345-Primary Dysmenorrhea Consensus Guideline. J Obstet Gynaecol Can. 2017 Jul;39(7):585-595. doi: 10.1016/j.jogc.2016.12.023.

  PMID: 28625286 BACKGROUND

• Blodt S, Pach D, Eisenhart-Rothe SV, Lotz F, Roll S, Icke K, Witt CM. Effectiveness of app-based self-acupressure for women with menstrual pain compared to usual care: a randomized pragmatic trial. Am J Obstet Gynecol. 2018 Feb;218(2):227.e1-227.e9. doi: 10.1016/j.ajog.2017.11.570. Epub 2017 Nov 15.

  PMID: 29155036 BACKGROUND

• Woo HL, Ji HR, Pak YK, Lee H, Heo SJ, Lee JM, Park KS. The efficacy and safety of acupuncture in women with primary dysmenorrhea: A systematic review and meta-analysis. Medicine (Baltimore). 2018 Jun;97(23):e11007. doi: 10.1097/MD.0000000000011007.

  PMID: 29879061 BACKGROUND

• Proctor ML, Smith CA, Farquhar CM, Stones RW. Transcutaneous electrical nerve stimulation and acupuncture for primary dysmenorrhoea. Cochrane Database Syst Rev. 2002;2002(1):CD002123. doi: 10.1002/14651858.CD002123.

  PMID: 11869624 BACKGROUND

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Jingxue Yuan

  Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingxue Yuan

CONTACT

+86-18810969209; yuanjingxue@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate of acupuncture department

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: June 6, 2019
• Study Start: July 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: May 1, 2021
• Last Updated: July 30, 2019

Record last verified: 2019-06

Locations

CN (1)