Dysmenorrhea Primary Clinical Trial
Official title:
Extracorporeal Shock Wave Therapy in the Treatment of Primary Dysmenorrhea:a Randomized Controlled-placebo Trial
Primary dysmenorrhea (PD) is a common female disease during menstruating. Although nonsteroidal anti-inflammatory drug is an effective treatment, there are concerns about side effects. Alternative therapies, including acupuncture and moxibustion, are commonly used for PD. Nevertheless, traditional Chinese medicine takes longer period than Western medicine to release PD. Extracorporeal shock wave therapy (ESWT) originally for the treatment of musculoskeletal diseases has characteristics of fast curative effect and no wound. Currently there is no report about clinical use of ESWT for the treatment of PD. Our study is to determine whether ESWT is effective in the treatment of PD based on meridian theory of traditional Chinese medicine. The investigators hypothesis that ESWT during PD is more effective than ESWT before PD or abdominal hot paste during PD without ESWT.
This randomized sham-controlled trial is to determine whether ESWT is effective in the
treatment of PD. Patients are randomly divided into 3 groups: 1. ESWT treatment during PD
(n=15); 2. ESWT treatment before PD(n=15); 3. abdominal hot paste during PD without
ESWT(n=15).
Exclusion criteria: secondary PD, concomitant chronic disease (epilepsy, gastrointestinal,
cardiovascular and renal diseases), taken oral contraceptives or vitamin/ mineral supplements
in the past 3 months, taking part in other clinical trials.
Medical history will be recorded before the treatment. A questionnaire will be filled by the
participant. Blood samples will be collected before and after the treatment. Participants
will be followed up closely by a professional nurse. Participants in group 1 will receive
ESWT treatment on day1 and day 3 of each menstrual cycle. Participants in group 2 will
receive twice ESWT treatment one week before the estimated first day of the menstrual cycle.
Participants in group 3 will receive hot compress paste on their belly 2 inches under the
navel whenever they feel painful during the menstrual cycle. Patients with PD are treated for
three menstrual cycles and followed by three menstrual cycles. Evaluation time point will be
one-menstrual cycle baseline, third-menstrual cycle treatment, and third-menstrual cycle
follow-up period. The investigators will inform participants to keep warm, avoid cold drink
and have a healthy lifestyle via telephone communication each week during the trial.
The plasma concentrations of prostaglandin F2a metabolite, PGE2, visual analogue scale (VAS),
and pictorial blood loss assessment chart (PBLA), total pain relief over 4 consecutive hours
(TOPAR4), Self-Rating Anxiety Scale (SAS) and other questionnaires about menstrual pain will
be recorded and evaluated before and after treatment.
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