Electroacupuncture for Dysmenorrhea Secondary to Adenomyosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorGuang'anmen Hospital of China Academy of Chinese Medical Sciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Electroacupuncture
DeviceHwato 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).
Sham Electroacupuncture
DeviceHwato 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Electroacupuncture, Then Sham ElectroacupunctureExperimental treatment 2 interventions
Group B: Sham Electroacupuncture, Then ElectroacupunctureSham comparator 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
The menstruation period of Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5 and Cycle 6 (each cycle is 24-38 days)]Secondary outcomes
1
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.
Time frame
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)]2
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.
Time frame
The menstruation period of Cycle 1, Cycle 4 and Cycle 7 (each cycle is 24-38 days)]3
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.
Time frame
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)]4
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.
Time frame
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)]Other outcomes
1
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?
Time frame
Before the first treatment session of electroacupuncture and sham electroacupuncture.2
Blinding assessment
Participants will be ask "do you think you have received traditional electroacupuncture in the past two cycles?"
Time frame
Within 5 minutes after the last treatment in Cycle 3 and Cycle 6 (each cycle is 24-38 days).3
Adherence assessment
Adherence will be assessment via counting treatment sessions. Those complete over 80% treatment sessions will be defined as of good adherence.
Time frame
The menstruation period of Cycle 2, Cycle 3, Cycle 5 and Cycle 6 (each cycle is 24-38 days).4
The change from baseline in the dose of rescue medicine.
The dose of rescue medicine that participants use to relieve dysmenorrhea-related pain.
Time frame
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)]Sponsors and contacts
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Source ClinicalTrials.gov