Electroacupuncture for Dysmenorrhea Secondary to Adenomyosis

Effect of Electroacupuncture for Dysmenorrhea Secondary to Adenomyosis: an Exploratory Pilot Study

The aim of this study is to preliminarily evaluate the is to assess the effects and safety of electroacupuncture for moderate to severe dysmenorrhea secondary to adenomyosis.

Study Overview

• Status: Not yet recruiting
• Conditions: Dysmenorrhea; Adenomyosis; Electroacupuncture
• Intervention / Treatment: Device: Electroacupuncture; Device: Sham Electroacupuncture

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhishun Liu; Phone Number: +861088002331; Email: zhishunjournal@163.com
• Study Contact Backup: Name: Min Yang; Phone Number: +8618810268077; Email: yangmin2019@yeah.net

Study Locations

• China
  • Beijing, China
    • Guang'anmen Hospital, China Academy of Chinese Medical Sciences
    • Contact: Min Yang; Phone Number: +8618810268077; Email: yangmin2019@yeah.net
    • Contact: Zhishun Liu, PhD; Phone Number: +861088002331; Email: zhishunjournal@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Meeting the diagnosis criteria of dysmenorrhea secondary to adenomyosis.
• Female patients aged between 18 and 50.
• Dysmenorrhea lasting for 3 consecutive menstrual cycles or more.
• At least three consecutive menstrual cycles with an interval of 24 to 38 days, differing by less than 7 days, and menstrual periods lasting 2 to 8 days before screening.
• At least 2 days of worst pain score ≥4 on Numerical Rating Scale during the screening period.
• Having not used medications, other than rescue medicine, or therapies for dysmenorrhea secondary to adenomyosis for at least 1 month before randomization, and consenting not to use throughout the process of the research.
• Volunteering to participate the trial and signing written informed consent.

Exclusion Criteria:

• Diagnosed with Endometriosis or having a history of endometriosis-related surgery
• Currently taking hormonal medications, including: a.use of GnRH agonists within 6 months before the screening period; b. use of progestins or danazol and other long-acting hormones within 3 months before the screening period; c. use of oral contraceptive-like short-acting hormones within one month before the screening period;
• Having clinically significant gynecologic condition such as clinically significant endometrial pathology, persistent complex ovarian cyst larger than 3 cm or simple ovarian cyst larger than 5 cm, or single fibroid 4 cm or larger or more than 4 fibroids measuring at least 2 cm or symptomatic submucosal fibroid of any size.
• having an IUD.
• HB < 90G/L.
• Having any other chronic pain syndrome that required chronic analgesic or other chronic therapy.
• Having a current history of undiagnosed abnormal genital bleeding.
• Malignant tumors (including the reproductive system and other systems).
• Combined with severe diseases in the cardiac, respiratory, renal, liver, and hematopoietic systems, psychiatric disorder and/or cognitive disorders.
• Pregnant, breast feeding, planning a pregnancy within the next 7 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electroacupuncture, Then Sham Electroacupuncture; Fifteen participants will first receive electroacupuncture for two consecutive menstrual cycles. After a washout period of one menstrual cycle, they then will receive sham electroacupuncture for another two consecutive menstrual cycles.	Device: Electroacupuncture; Hwato brand disposable acupuncture needles (size 0.30 × 40 mm and 0.30 × 75 mm) and SDZ-V electroacupuncture apparatus will be used. Acupoints of Ciliao (BL32), Shiqizhui (EX-B8), and Sanyinjiao (SP6) will be used for participants. The needles will be inserted to 60-70mm in BL32 and 25-30mm in EX-B8 and SP6. Needle manipulation will be conducted (except for BL32) to achieve deqi sensation. Then paired electrodes from the electroacupuncture apparatus will be attached transversely to the needle handles at bilateral BL32 and SP6. The electroacupuncture stimulation will last for 30 minutes with a continuous wave of 5Hz and a current intensity of 1 to 5mA. Current intensity was adjusted according to the patients' individual tolerance.Treatment will start within one week before the onset of menstruation and stop before the end of menstruation, three sessions per menstrual cycle in total (ideally every two to three days and at least one session during menstruation period).; Device: Sham Electroacupuncture; Hwato brand disposable acupuncture needles (size 0.25 × 40 mm and 0.30 × 25 mm) and SDZ-V electroacupuncture apparatus will be used. Sham acupoints of BL32, EX-B8 and SP6 will be used for every participants. The needles will be inserted to 2-3mm in sham acupoints. Procedures, electrode placements, and other treatment settings were the same as in the electroacupuncture group but with no electricity output or needle manipulation for de qi.
Sham Comparator: Sham Electroacupuncture, Then Electroacupuncture; Fifteen participants will receive sham electroacupuncture for two consecutive menstrual cycles. After a washout period of one menstrual cycle, they then will receive electroacupuncture for another two consecutive menstrual cycles.	Device: Electroacupuncture; Hwato brand disposable acupuncture needles (size 0.30 × 40 mm and 0.30 × 75 mm) and SDZ-V electroacupuncture apparatus will be used. Acupoints of Ciliao (BL32), Shiqizhui (EX-B8), and Sanyinjiao (SP6) will be used for participants. The needles will be inserted to 60-70mm in BL32 and 25-30mm in EX-B8 and SP6. Needle manipulation will be conducted (except for BL32) to achieve deqi sensation. Then paired electrodes from the electroacupuncture apparatus will be attached transversely to the needle handles at bilateral BL32 and SP6. The electroacupuncture stimulation will last for 30 minutes with a continuous wave of 5Hz and a current intensity of 1 to 5mA. Current intensity was adjusted according to the patients' individual tolerance.Treatment will start within one week before the onset of menstruation and stop before the end of menstruation, three sessions per menstrual cycle in total (ideally every two to three days and at least one session during menstruation period).; Device: Sham Electroacupuncture; Hwato brand disposable acupuncture needles (size 0.25 × 40 mm and 0.30 × 25 mm) and SDZ-V electroacupuncture apparatus will be used. Sham acupoints of BL32, EX-B8 and SP6 will be used for every participants. The needles will be inserted to 2-3mm in sham acupoints. Procedures, electrode placements, and other treatment settings were the same as in the electroacupuncture group but with no electricity output or needle manipulation for de qi.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change from baseline in the numerical rating scale (NRS) score on the worst pain	Participants will rate their worst pain during menstruation period of each menstrual cycle on a 0-10 NRS scale, where 0 refers to no pain and 10 refers to the worst pain imaginable. The highest worst pain score of the each cycle will be taken as final NRS score on the worst pain.	The menstruation period of Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5 and Cycle 6 (each cycle is 24-38 days)]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change from baseline in the numerical rating scale (NRS) score on the average pain	Participants will rate their average pain during menstruation period of each menstrual cycle on a 0-10 NRS scale, where 0 refers to no pain and 10 refers to the worst pain imaginable. The final NRS score on average pain is defined as the mean of the average pain scores of each cycle.	The menstruation period of Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 and Cycle 7 (each cycle is 24-38 days)]
The change from baseline in the numerical rating scale (NRS) score on the worst pain.	Participants will rate their worst pain during menstruation period of each menstrual cycle on a 0-10 NRS scale, where 0 refers to no pain and 10 refers to the worst pain imaginable. The highest worst pain score of the each cycle will be taken as final NRS score on the worst pain.	The menstruation period of Cycle 1, Cycle 4 and Cycle 7 (each cycle is 24-38 days)]
Proportion of participants with at least 30% reduction of numerical rating scale (NRS) score on average pain.	Participants will rate their average pain during menstruation period of each menstrual cycle on a 0-10 NRS scale, where 0 refers to no pain and 10 refers to the worst pain imaginable. The final NRS score on average pain is defined as the mean of the average pain scores of each cycle.	The menstruation period of Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 and Cycle 7 (each cycle is 24-38 days)]
Proportion of participants with at least 30% reduction of numerical rating scale (NRS) score on the worst pain.	Participants will rate their worst pain during menstruation period of each menstrual cycle on a 0-10 NRS scale, where 0 refers to no pain and 10 refers to the worst pain imaginable. The highest worst pain score of the each cycle will be taken as final NRS score on the worst pain.	The menstruation period of Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 and Cycle 7 (each cycle is 24-38 days)]
The change from baseline in the Pictorial Blood Loss Assessment Chart (PBAC) score.	After using each piece of sanitary napkin from the beginning to the end of each menstrual period, participants record it in a diary card according to the Pictorial Blood Loss Assessment Chart (PBAC) score. To ensure accuracy, participants are instructed to use sanitary napkins of the same size. The PBAC includes two parts of scoring records: the size of blood stain area in a sanitary napkin and lost blood clots.	The menstruation period of Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 and Cycle 7 (each cycle is 24-38 days)]
The change from baseline in the the Cox Menstrual Symptom Scale (CMSS).	The Cox Menstrual Symptom Scale (CMSS) consists of 18 items related to dysmenorrhea symptoms, such as lower abdominal pain, nausea, and headache, and each item is scored on a 5-point scale to measure severity and duration. Higher score corresponds to more severe dysmenorrhea symptoms.	The menstruation period of Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 and Cycle 7 (each cycle is 24-38 days)]
The change from baseline in the Short Form Endometriosis Health Profile Questionnaire (EHP-5).	The Short Form Endometriosis Health Profile Questionnaire (EHP-5) is also commonly used to assess quality of life in patients with adenomyosis. The Questionnaire consists of 12 questions answered by a score of 1-5 points, the higher the score, the lower the quality of life.	The last week of Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 and Cycle 7 (each cycle is 24-38 days)]
The change from baseline in the total and sub scores of Hospital Anxiety and Depression Scale (HADS).	Hospital Anxiety and Depression Scale (HADS) consists of 14 items, divided into two 7 item subscales to reeect a state of generalized anxiety and the depression. The respondent rates each item on a 4-point scale ranging from 0 (absence) to 3 (extreme presence).	The last week of Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 and Cycle 7 (each cycle is 24-38 days)]

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with positive expectance assessment	Participants will be asked what do you think the condition of dysmenorrhea will be in two menstrual cycles?	Before the first treatment session of electroacupuncture and sham electroacupuncture.
Blinding assessment	Participants will be ask "do you think you have received traditional electroacupuncture in the past two cycles?"	Within 5 minutes after the last treatment in Cycle 3 and Cycle 6 (each cycle is 24-38 days).
Adherence assessment	Adherence will be assessment via counting treatment sessions. Those complete over 80% treatment sessions will be defined as of good adherence.	The menstruation period of Cycle 2, Cycle 3, Cycle 5 and Cycle 6 (each cycle is 24-38 days).
The change from baseline in the dose of rescue medicine.	The dose of rescue medicine that participants use to relieve dysmenorrhea-related pain.	The menstruation period of Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 and Cycle 7 (each cycle is 24-38 days)]

Collaborators and Investigators

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Investigators: Principal Investigator: Zhishun Liu, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: April 2, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Estimated): April 15, 2024

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Dysmenorrhea; Adenomyosis; Electroacupuncture
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Uterine Diseases; Menstruation Disturbances; Pelvic Pain; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Dysmenorrhea; Adenomyosis
• Other Study ID Numbers: 2024-011-KY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Deidentified participant data and data dictionary will be available with the publication until six months after publication.

A formal request should be sent to zhishunjournal@163.com with a methodologically sound proposal.

Researchers whose proposal has been approved will sign a data access agreement.

• IPD Sharing Time Frame: The data will be available with the publication until six months after publication.

IPD Sharing Access Criteria

A formal request should be sent to zhishunjournal@163.com with a methodologically sound proposal. Researchers whose proposal has been approved.

Researchers whose proposal has been approved will sign a data access agreement.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No