Back to resultsAcupuncture for Female With Non-cyclic Chronic Pelvic Pain
Primary Purpose
Chronic Pelvic Pain
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acupuncture
Sham acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pelvic Pain focused on measuring Acupuncture, Sham acupuncture, Randomized controlled trial, Non-cyclic chronic pelvic pain
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
No Intervention
Arm Label
Acupuncture group
Sham acupuncture group
Waiting list group
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04553562
First Posted
September 6, 2020
Last Updated
November 20, 2021
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04553562
Brief Title
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
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2021 (Anticipated)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pelvic Pain
Keywords
Acupuncture, Sham acupuncture, Randomized controlled trial, Non-cyclic chronic pelvic pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Participants in the acupuncture and sham acupuncture will be blinded.
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture group
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham acupuncture group
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Waiting list group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Acupuncture
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change from baseline of the mean score in the past week of the Visual Analogue Scale
Description
The scores of the Visual Analogue Scale range from 0 to 10，higher scores mean a worse outcome.
Time Frame
Week 6, 18 and 30
Secondary Outcome Measure Information:
Title
The change from baseline of the Brief Pain Inventory score
Description
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.
Time Frame
Week 6, 18 and 30
Title
The change from baseline of the pain severity score of the Brief Pain Inventory
Description
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.
Time Frame
Week 6, 18 and 30
Title
The change from baseline of the pain interference score of the Brief Pain Inventory
Description
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.
Time Frame
Week 6, 18 and 30
Title
The proportion of patients with decrease of 0.6 score or more from baseline of the pain interference score of the Brief Pain Inventory
Description
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.
Time Frame
Week 6, 18 and 30
Title
The proportion of patients with decrease of 20% or more from baseline of the pain severity score of the Brief Pain Inventory
Description
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.
Time Frame
Week 6, 18 and 30
Title
The change from baseline of the Pain Catastrophising Questionnaire score
Description
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.
Time Frame
Week 6, 18 and 30
Title
The change from baseline of the Hospital Anxiety and Depression Scale score
Description
the score of the Hospital Anxiety and Depression Scale ranges from 0 to 42. Higher scores mean a worse outcome.
Time Frame
Week 6, 18 and 30
Title
The change from baseline of the World Health Organisation Quality of life - Bref Questionnaire score
Description
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.
Time Frame
Week 6, 18 and 30
Title
The proportions of participants in each response category of the Patient global impression of change
Description
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.
Time Frame
Week 6, 18 and 30
Title
The proportion of subjects using rescue medications and the duration of medication use
Description
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.
Time Frame
Week 6, 18 and 30
Other Pre-specified Outcome Measures:
Title
Blinding assessment
Description
To test the success of blinding, participants in the acupuncture group and the SA group will be asked to reply to the following question at the 6th week of treatment (sessions 18): "Do you think you have received traditional acupuncture in the past weeks?" The participants will be able to choose one of the following options as the answer: "Yes", "No" or "Unclear".
Time Frame
Week 6
Title
Safety assessment
Description
We will handle and document the adverse events (AEs) using the standard operating procedures for monitoring and reporting all AEs. According to their potential association with the treatment, AEs will be categorized as treatment-related or non-treatment-related within 24 hours after their occurrence. Treatment-related AEs include pain, haematoma, localized infection, broken needle, fainting, nausea, headache, dizziness, insomnia, vomiting, or palpitations during or after treatment. In addition, adverse events that are irrelevant to the treatment will be recorded during the study period.
Time Frame
Week 0 to 30
Title
Expectation of improvement assessment
Description
Patients choosing "improved" in the expectation assessment will be asked: "To what extent do you think your pelvic pain will be helped after acupuncture treatment?" Participants will choose the answer from the following options: a great degree, a moderate degree, a small degree, unclear.
Time Frame
Baseline
Title
Trust evaluation of acupuncture therapy
Description
Patients choosing "improved" in the expectation assessment will be asked: "To what extent do you think your pelvic pain will be helped after acupuncture treatment?" Participants will choose the answer from the following options: a great degree, a moderate degree, a small degree, unclear.
Time Frame
Baseline and week 6
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhishun Liu, PhD
Phone
86-010-88002331
Email
liuzhishun@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Zhou, PhD
Phone
86-010-15650729586
Email
zjinbj@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhishun Liu, PhD
Organizational Affiliation
Guang'an men hospital, China Academy of Chinese Medical Sciences
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Acupuncture for Female With Non-cyclic Chronic Pelvic Pain
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