Chronic Pelvic PainNCT04553562
Acupuncture for Female With Non-cyclic Chronic Pelvic Pain
A study testing Acupuncture in people with Chronic Pelvic Pain, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Chronic Pelvic Pain
- What is being tested?
- Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy of Acupuncture for Female With Non-cyclic Chronic Pelvic Pain: a Three-armed Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Chronic Pelvic Pain
- Being tested
- Acupuncture, Sham acupuncture
- Keywords
- Acupuncture, Sham acupuncture, Randomized controlled trial, Non-cyclic chronic pelvic pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
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.
Sham acupunctureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture group | Experimental | 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. Receives: Device: Acupuncture |
| Sham acupuncture group | Sham comparator | 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. Receives: Device: Sham acupuncture |
| Waiting list group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 6, 18 and 30
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 6, 18 and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start1 Dec 2021 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pelvic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Zhishun Liu, PhD, Study chair, Guang'an men hospital, China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553562
- Sponsor's protocol ID
- 2019-248-KY
- Status last verified
- Nov 2021
- First submitted
- 6 Sep 2020
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Acupuncture for Female With Non-cyclic Chronic Pelvic Pain: a Three-armed Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04553562
- Acronym / sponsor ID
- 2019-248-KY
- Conditions
- Chronic Pelvic Pain
- Keywords
- Acupuncture, Sham acupuncture, Randomized controlled trial, Non-cyclic chronic pelvic pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 17 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupuncture group | Experimental | Device: AcupunctureFor 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. |
| Sham acupuncture group | Sham comparator | Device: Sham acupunctureFor 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. |
| Waiting list group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureSterile 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. | Device | Acupuncture group |
| Sham acupunctureSterile 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. | Device | Sham acupuncture group |
Primary outcome
The change from baseline of the mean score in the past week of the Visual Analogue Scale
Time frame: Week 6, 18 and 30
The scores of the Visual Analogue Scale range from 0 to 10，higher scores mean a worse outcome.
10 secondary outcomes
The change from baseline of the Brief Pain Inventory score
Time frame: Week 6, 18 and 30
The change from baseline of the pain severity score of the Brief Pain Inventory
Time frame: Week 6, 18 and 30
The change from baseline of the pain interference score of the Brief Pain Inventory
Time frame: 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
Time frame: 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
Time frame: Week 6, 18 and 30
The change from baseline of the Pain Catastrophising Questionnaire score
Time frame: Week 6, 18 and 30
The change from baseline of the Hospital Anxiety and Depression Scale score
Time frame: Week 6, 18 and 30
The change from baseline of the World Health Organisation Quality of life - Bref Questionnaire score
Time frame: Week 6, 18 and 30
The proportions of participants in each response category of the Patient global impression of change
Time frame: Week 6, 18 and 30
The proportion of subjects using rescue medications and the duration of medication use
Time frame: Week 6, 18 and 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhishun Liu, PhD study chair
Guang'an men hospital, China Academy of Chinese Medical Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Chronic Pelvic Pain, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhishun Liu, PhD (86-010-88002331, liuzhishun@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change from baseline of the mean score in the past week of the Visual Analogue Scale (time frame: Week 6, 18 and 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2021.