Clinical trial NCT04553562: Acupuncture for Female With Non-cyclic Chronic Pelvic Pain
Official title: Efficacy of Acupuncture for Female With Non-cyclic Chronic Pelvic Pain: a Three-armed Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pelvic Pain
Keywords: Acupuncture
Sham acupuncture
Randomized controlled trial
Non-cyclic chronic pelvic pain
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2020-09-17
Enrollment: 150
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: Chronic pelvic pain (CPP) is one of the common symptoms of women at childbearing age. The aim of this study is to assess the efficacy of acupuncture for female with non-cyclic chronic pelvic pain. A three-arm randomized controlled trial (RCT) using acupuncture, sham acupuncture and waiting list with a total sample of 150 will be conducted.

Detailed description: Chronic pelvic pain (CPP) is a persistent pain in pelvis, anterior abdominal wall, lower back, or buttocks lasting at least six months. According to a WHO epidemiological study, the worldwide prevalence rate of CPP in childbearing age women was 2.1%-24%. At present, nearly 55% of the patients had unclear etiology, and there is no universally accepted diagnosis, evaluation and treatment. CPP is often associated with gynecological and non gynecological diseases, including endometriosis, abdominal visceral adhesion, myofascial pain and dysfunction, irritable bowel syndrome and interstitial cystitis/bladder pain syndrome. CPP are also accompanied by psychological and physiological dysfunction, the most common is depression and anxiety, which seriously affects the quality of life of patients.

Acupuncture may have effect on non-cyclic CPP in female, however, there is a lack of evidence of effectiveness of acupuncture. A multi-center randomized three-armed controlled trial will be conducted. The aim of this study is assess the efficacy and safety of acupuncture for female patients with non-cyclic CPP.

Eligibility criteria: Inclusion Criteria:

* Meet the diagnostic criteria of non-cyclic CPP.
* Age 18 to 50 years.
* Have moderate to severe pain in pelvis, anterior abdominal wall, lower back, or buttocks lasting at least six months.
* The mean degree of pelvic pain in the past week rated by Visual Analogue Scale is ≥40 scores.
* Sign informed consent and participate in the study voluntarily.

Exclusion Criteria:

* Have endometriosis (including adenomyosis), ovarian cyst (larger than 3cm), hysteromyoma (larger than 3cm), severe pelvic adhesion, pelvic malignant tumor (relevant examination must be within the last 6 months).
* Have acute pelvic/urinary tract infection.
* Have pain after pelvic surgery.
* Have recurrent gastrointestinal or bladder diseases such as irritable bowel syndrome, interstitial cystitis / bladder pain syndrome, etc.
* During pregnancy or in lactation or have a pregnancy plan within 8 months.
* Have heart, lung, liver, kidney, mental disorders or cognitive dysfunction.
* Have acupuncture treatment in recent 3 months.

Primary outcomes:
measure: The change from baseline of the mean score in the past week of the Visual Analogue Scale
timeFrame: Week 6, 18 and 30
Secondary outcomes:
measure: The change from baseline of the Brief Pain Inventory score
timeFrame: Week 6, 18 and 30
measure: The change from baseline of the pain severity score of the Brief Pain Inventory
timeFrame: Week 6, 18 and 30
measure: The change from baseline of the pain interference score of the Brief Pain Inventory
timeFrame: Week 6, 18 and 30
measure: The proportion of patients with decrease of 0.6 score or more from baseline of the pain interference score of the Brief Pain Inventory
timeFrame: Week 6, 18 and 30
measure: The proportion of patients with decrease of 20% or more from baseline of the pain severity score of the Brief Pain Inventory
timeFrame: Week 6, 18 and 30
measure: The change from baseline of the Pain Catastrophising Questionnaire score
timeFrame: Week 6, 18 and 30
measure: The change from baseline of the Hospital Anxiety and Depression Scale score
timeFrame: Week 6, 18 and 30
measure: The change from baseline of the World Health Organisation Quality of life - Bref Questionnaire score
timeFrame: Week 6, 18 and 30
measure: The proportions of participants in each response category of the Patient global impression of change
timeFrame: Week 6, 18 and 30
measure: The proportion of subjects using rescue medications and the duration of medication use
timeFrame: Week 6, 18 and 30
Other outcomes:
measure: Blinding assessment
timeFrame: Week 6
measure: Safety assessment
timeFrame: Week 0 to 30
measure: Expectation of improvement assessment
timeFrame: Baseline
measure: Trust evaluation of acupuncture therapy
timeFrame: Baseline and week 6
Locations:
Study officials:
affiliation: Guang'an men hospital, China Academy of Chinese Medical Sciences
name: Zhishun Liu, PhD
role: STUDY_CHAIR
References: