Acupuncture for Female With Non-cyclic Chronic Pelvic Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Acupuncture for Female With Non-cyclic Chronic Pelvic Pain: a Three-armed Randomized Controlled Trial

Conditions
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Chronic Pelvic Pain

Intervention / Treatment
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* Device: Acupuncture
* Device: Sham acupuncture


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture group<br>For acupuncture group, sterile adhesive pads will be placed after skin disinfection on the acupoints. Guanyuan (CV4)，Qihai (CV6)，bilateral Sanyinjiao (SP6), Yinbao (LR9), Qixue (KI13) and Fujie (SP14) will be inserted through the pads. The participants will be treated three times a week, on alternate days, for 6 successive weeks; 18 sessions for each patient in total. | Device: Acupuncture<br>* Sterile adhesive pads will be placed after skin disinfection on the acupoints. Guanyuan (CV4)，Qihai (CV6)，bilateral Sanyinjiao (SP6), Yinbao (LR9), Qixue (KI13) and Fujie (SP14) will be inserted through the pads by the needles (0.30mm in diameter, 40 mm in length, Hwato Brand, Suzhou Medical Appliance Factory, China) to a depth of 25-30mm. Yintang (GV4) will be inserted through the pads by the needle (0.30mm in diameter, 25mm in length, Hwato Brand, Suzhou Medical Appliance Factory, China) to a depth of 10-15mm. The needles at all points will be lightly lifting, thrusting, and twirling every 10 minutes during each session with the sensation of sourness, achiness, heaviness and numbness (deqi). The participants will be treated three times a week, on alternate days (ideally), for 6 successive weeks; 18 sessions for each patient in total.<br>|
| Sham Comparator: Sham acupuncture group<br>For the sham acupuncture group, aterile adhesive pads will be placed after skin disinfection on the acupoints and needles with a blunt tip will be inserted at the same acupoints in the acupuncture group without penetrating the skin.No manipulation of needles will be conducted. The participants will be treated three times a week, on alternate days (ideally), for 6 successive weeks; 18 sessions for each patient in total. | Device: Sham acupuncture<br>* Sterile adhesive pads will be placed after skin disinfection on the acupoints. Needles (0.30 mm in diameter, 25 mm in length) with a blunt tip will be inserted at the Guanyuan (CV4)，Qihai (CV6)，bilateral Sanyinjiao (SP6), Yinbao (LR9), Qixue (KI13) and Fujie (SP14) without penetrating the skin. The participants will be treated three times a week, on alternate days (ideally), for 6 successive weeks; 18 sessions for each patient in total.<br>|
| No Intervention: Waiting list group<br>For the waiting list group, patients will receive no treatment in the first 6 weeks and will receive the same treatment used in the acupuncture group according to patients' preference. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline of the mean score in the past week of the Visual Analogue Scale | The scores of the Visual Analogue Scale range from 0 to 10，higher scores mean a worse outcome. | Week 6, 18 and 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline of the Brief Pain Inventory score | The Brief Pain Inventory score uses 0-10 numeric scales for item rating with 0 being no pain and 10 being pain as bad as you can imagine. The pain severity score is calculated from the four items about pain intensity with a range from 0 to 40. The pain interference score corresponds to the item on pain interference with a range from 0 to 70. Higher scores of the Brief Pain Inventory mean a worse outcome. | Week 6, 18 and 30 | 
| The change from baseline of the pain severity score of the Brief Pain Inventory | The pain severity score of the Brief Pain Inventory is calculated from the four items about pain intensity. Each item is rated from no pain to pain as bad as you can imagine, and contributes with the same weight to the final score, ranging from 0 to 40. The pain interference score corresponds to the item on pain interference. Higher scores of the The pain severity score mean a worse outcome. | Week 6, 18 and 30 | 
| The change from baseline of the pain interference score of the Brief Pain Inventory | The pain interference score of the Brief Pain Inventory corresponds to the item on pain interference. The seven subitems are rated from does not interfere to completely interferes, and contributes with the same weight to the final score, ranging from 0 to 70. Higher scores of the pain interference score mean a worse outcome. | Week 6, 18 and 30 | 
| The proportion of patients with decrease of 0.6 score or more from baseline of the pain interference score of the Brief Pain Inventory | The pain interference score of the Brief Pain Inventory corresponds to the item on pain interference. The seven subitems are rated from does not interfere to completely interferes, and contributes with the same weight to the final score, ranging from 0 to 70. Higher scores of the pain interference score mean a worse outcome. | Week 6, 18 and 30 | 
| The proportion of patients with decrease of 20% or more from baseline of the pain severity score of the Brief Pain Inventory | The pain severity score of the Brief Pain Inventory is calculated from the four items about pain intensity. Each item is rated from no pain to pain as bad as you can imagine, and contributes with the same weight to the final score, ranging from 0 to 40. The pain interference score corresponds to the item on pain interference. Higher scores of the The pain severity score mean a worse outcome. | Week 6, 18 and 30 | 
| The change from baseline of the Pain Catastrophising Questionnaire score | The Pain Catastrophising Questionnaire is a validated scale with 13 items, each scored from 0 (not at all) to 4 (all the time) with a total score range of 0-52, across three domains: rumination (0-16); magnifications (0-12); and helplessness (0-24).Higher scores of the Pain Catastrophising Questionnaire mean a worse outcome. | Week 6, 18 and 30 | 
| The change from baseline of the Hospital Anxiety and Depression Scale score | the score of the Hospital Anxiety and Depression Scale ranges from 0 to 42. Higher scores mean a worse outcome. | Week 6, 18 and 30 | 
| The change from baseline of the World Health Organisation Quality of life - Bref Questionnaire score | Domain scores for the World Health Organisation Quality of life-Bref Questionnaire score are calculated by taking the mean of all items included in each domain and multiplying by a factor of four. These scores are then transformed to a 0-100 scale.Higher scores denote higher quality of life. | Week 6, 18 and 30 | 
| The proportions of participants in each response category of the Patient global impression of change | Patient global impression of change consists of 7 response categories with a range of 1-7: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. Higher scores mean a worse outcome. | Week 6, 18 and 30 | 
| The proportion of subjects using rescue medications and the duration of medication use | The use of medications during this trial. However, medication use is allowed for intolerable symptoms as long as it is recorded accordingly, including the name, the dosage, and the duration of the medication use. | Week 6, 18 and 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, Sham acupuncture, Randomized controlled trial, Non-cyclic chronic pelvic pain