Evaluation of the safety and efficacy of semiconductor laser irradiation at Guanyuan point in the treatment of primary dysmenorrhea: a randomized, double-blind, placebo-controlled trial
- Conditions
- Primary dysmenorrhea
- Registration Number
- ITMCTR2100004822
- Lead Sponsor
- anjing Drum Tower Hospital The Affiliated Hospital Of Nanjing University Medical School
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- Not specified
1. Diagnosed as primary dysmenorrhea according to the primary dysmenorrhea management guidelines issued by the Society of Obstetricians and Gynecologists of Canadian in 2017;
2. Females aged 18 to 30 years who have not given birth;
3. Menstrual cycle regularity: 28±7 days;
4. Periodic pain during menstruation for 6 months and above;
5. The average pain score of the Visual Analogue Scale (VAS) of the last 3 menstrual cycles is >=4 points;
6. Volunteer to participate in the trial and sign an informed consent form.
1. Patients with secondary dysmenorrhea caused by gynecological diseases such as endometriosis, pelvic inflammatory disease, adenomyosis or other diseases confirmed by gynecological examination and B-ultrasound;
2. Oral contraceptives or drugs that act on the central nervous system within 1 month before treatment, or have received relevant physical therapy;
3. Are participating in or have participated in other drugs or other types of clinical trials within the past 1 month;
4. There are abnormalities such as ulceration and infection in the skin of the irradiation site;
5. Suffering from severe mental or other diseases, unable to correctly score the pain or unable to objectively describe the symptoms;
6. History of phototherapy allergy;
7. Women who are pregnant, breastfeeding or planning to become pregnant;
8. There are objections to the treatment of this trial or the inability to receive regular follow-ups.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method visual analogue scale;
- Secondary Outcome Measures
Name Time Method Self-rating anxiety scale;Epoxidase dysmenorrhea symptom scale score;Self-rating depression scale;Time and degree of lower abdomen pain;