Clinical trial NCT05223517: Acupuncture for Chronic Pelvic Pain
Official title: Effect of Acupuncture for Chronic Pelvic Pain in Women: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acupuncture, Chronic Pelvic Pain, Woman
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 216
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of participants with at least 50% reduction of numerical rating scale (NRS) score on average pain.
timeFrame: Weeks 5-8
Secondary outcomes:
measure: Proportion of participants with at least 50% reduction of numerical rating scale (NRS) score on average pain.
timeFrame: Weeks 1-4, 9-12, 13-16, 17-20.
measure: Proportion of participants with at least 50% reduction of numerical rating scale (NRS) score on the worst pain.
timeFrame: Weeks 1-4, 5-8, 9-12, 13-16, 17-20.
measure: The change from baseline in the numerical rating scale (NRS) score on average pain.
timeFrame: Weeks 1-4, 5-8, 9-12, 13-16, 17-20.
measure: The change from baseline in the numerical rating scale (NRS) score on the worst pain.
timeFrame: Weeks 1-4, 5-8, 9-12, 13-16, 17-20.
measure: Proportion of participants with at least 30% reduction of numerical rating scale (NRS) score on average pain.
timeFrame: Weeks 1-4, 5-8, 9-12, 13-16, 17-20.
measure: Proportion of participants with at least 30% reduction of numerical rating scale (NRS) score on the worst pain.
timeFrame: Weeks 1-4, 5-8, 9-12, 13-16, 17-20.
measure: The change from baseline in the interferes score of Brief Pain Inventory (BPI) short form.
timeFrame: Weeks 4, 8, 12, 16, 20
measure: The proportion of participants rates their overall improvement as "very much improved" or "much improved" based on the Patient Global Impression-Change (PGI-C) .
timeFrame: Weeks 8 and 20
measure: The change from baseline in the Female Sexual Function Index (FSFI) score.
timeFrame: Weeks 8 and 20
measure: The change from baseline in the total and sub scores of Hospital Anxiety and Depression Scale (HADS).
timeFrame: Weeks 4, 8 and 20
measure: The change from baseline in the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) questionnaire.
timeFrame: Weeks 4, 8 and 20
Other outcomes:
measure: Expectance assessment
timeFrame: Baseline
measure: Assessment of belief in acupuncture
timeFrame: Baseline, week 4, week 8
measure: Blinding assessment
timeFrame: Within 5 minutes after either treatment in week 8
measure: Adherence assessment
timeFrame: Weeks 1-8
measure: Proportion of participants using rescue medicine.
timeFrame: Through study completion, an average of 3 years
measure: Proportion of participants using concomitant medicine or therapy that might impact chronic pelvic pain.
timeFrame: Through study completion, an average of 3 years
Locations:
city: Beijing
country: China
facility: China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
References: