Acupuncture for Chronic Pelvic Pain

  • STATUS
    Recruiting
  • End date
    Dec 12, 2024
  • participants needed
    216
  • sponsor
    Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Updated on 12 April 2022

Summary

The aim of the study is to assess the effects and safety of acupuncture for moderate to severe chronic pelvic pain in women.

Details
Condition Acupuncture, Chronic Pelvic Pain, Woman
Treatment Acupuncture, Sham acupuncture
Clinical Study IdentifierNCT05223517
SponsorGuang'anmen Hospital of China Academy of Chinese Medical Sciences
Last Modified on12 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Female patients aged between 18 and 50
Chronic pelvic pain (with or without dysmenorrhoea or dyspareunia) of at least 6 months duration
Having not used medications, other than rescue medicine, or therapies for chronic pelvic pain for at least 4 weeks before randomization, and consenting not to use throughout the process of the research
Completing Weekly Pain Diary for at least three week during the four-week run-in period, and at least two of the worst pain scoring ≥4 on the Numeric Rating Scale
Volunteering to participate the trial and signing written informed consent

Exclusion Criteria

Cyclical chronic pelvic pain, such as only with dysmenorrhea
Endometriosis
Adenomyosis
Complex ovarian cyst
Accessory cyst >5cm
Uterine fibroids >5cm
Malignant disease
Anterior sacral neurectomy or uterine sacral nerve ablation before or scheduled in the next 6 month
Irritable bowel syndrome
Symptomatic urinary tract infection
Acute pelvic inflammation
Uncontrolled vaginitis
Lactation period, pregnancy, or fetation planned in the next 6 months
Sever disorders in heart, lung, brain, liver, kidney and hematopoietic system, or obvious psychiatric or cognitive dysfunction
Poor adherence
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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