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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
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).
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.
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, China
RECRUITINGThe 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)]
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)]
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)]
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)]
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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)]
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.
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)]
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.
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)]
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.
Time frame: 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).
Time frame: 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)]