Effect of Acupuncture for Chronic Pelvic Pain in Women: a Randomized Clinical Trial

Guang'anmen Hospital of China Academy of Chinese Medical Sciences1 site in 1 country216 target enrollmentMarch 6, 2022

ConditionsAcupuncture, Chronic Pelvic Pain, Woman

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Acupuncture, Chronic Pelvic Pain, Woman
Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Enrollment: 216
Locations: 1
Primary Endpoint: Proportion of participants with at least 50% reduction of numerical rating scale (NRS) score on average pain.
Status: Recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

March 6, 2022

End Date

December 2024

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Responsible Party

Principal Investigator

Yuanjie Sun

Principal Investigator

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Eligibility Criteria

Inclusion Criteria

•Female patients aged between 18 and
•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.

Outcomes

Primary Outcomes

Proportion of participants with at least 50% reduction of numerical rating scale (NRS) score on average pain.

Time Frame: Weeks 5-8

Participants will rate their average chronic pelvic pain each week 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 the four weeks.

Secondary Outcomes

Proportion of participants with at least 50% reduction of numerical rating scale (NRS) score on average pain.(Weeks 1-4, 9-12, 13-16, 17-20.)
Proportion of participants with at least 50% reduction of numerical rating scale (NRS) score on the worst pain.(Weeks 1-4, 5-8, 9-12, 13-16, 17-20.)
The change from baseline in the numerical rating scale (NRS) score on average pain.(Weeks 1-4, 5-8, 9-12, 13-16, 17-20.)
The change from baseline in the numerical rating scale (NRS) score on the worst pain.(Weeks 1-4, 5-8, 9-12, 13-16, 17-20.)
Proportion of participants with at least 30% reduction of numerical rating scale (NRS) score on average pain.(Weeks 1-4, 5-8, 9-12, 13-16, 17-20.)
Proportion of participants with at least 30% reduction of numerical rating scale (NRS) score on the worst pain.(Weeks 1-4, 5-8, 9-12, 13-16, 17-20.)
The change from baseline in the interferes score of Brief Pain Inventory (BPI) short form.(Weeks 4, 8, 12, 16, 20)
The proportion of participants rates their overall improvement as "very much improved" or "much improved" based on the Patient Global Impression-Change (PGI-C) .(Weeks 8 and 20)
The change from baseline in the Female Sexual Function Index (FSFI) score.(Weeks 8 and 20)
The change from baseline in the total and sub scores of Hospital Anxiety and Depression Scale (HADS).(Weeks 4, 8 and 20)
The change from baseline in the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) questionnaire.(Weeks 4, 8 and 20)