Acupuncture, Chronic Pelvic Pain, WomanNCT05223517
Acupuncture for Chronic Pelvic Pain
A study testing Acupuncture in people with Acupuncture, Chronic Pelvic Pain, Woman, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
The aim of the study is to assess the effects and safety of acupuncture for moderate to severe chronic pelvic pain in women. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Acupuncture, Chronic Pelvic Pain, Woman
- 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
- 216 participants
- Where
- 1 siteChina
- Study dates
- 6 Mar 2022to Dec 2024
- 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
- 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.
Who cannot join
- Cyclical chronic pelvic pain, such as only with dysmenorrhea.
- Endometriosis.
- Adenomyosis.
- Complex ovarian cyst.
- Accessory cyst >5cm.
- Uterine fibroids >5cm.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100053
Yuanjie Sun, PhD, 86 18810337542, puzhisun@163.com
About this study
Official title: Effect of Acupuncture for Chronic Pelvic Pain in Women: a Randomized Clinical Trial
The aim of the study is to assess the effects and safety of acupuncture for moderate to severe chronic pelvic pain in women.
- Conditions
- Acupuncture, Chronic Pelvic Pain, Woman
- Being tested
- Acupuncture, Sham Acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
Hwato brand disposable acupuncture needles (size 0.30 × 40 mm and 0.30 × 75 mm) and adhesive pads will be used. Acupoints of Ciliao, Huiyang, Shenshu, Guanyuan, Shuidao, Sanyinjiao, Zusanli, Taixi, Hegu, and Taichong will be used for every participants. Those with sleep or mood disorders will also use acupoints of Shangyintang, Shenmen and Neiguan. Those with tenderness points on the abdominal wall will also use Ashi points no more than five.
The needles will be inserted to 60-70mm in Ciliao and Huiyang, 6-10 mm in Shenmen and 10-20mm in other acupoints through adhesive pads. Needles will be lifted, thrusted and twirled gently for 3 times (except for Ciliao) to achieve deqi sensation and manipulated every ten minutes during 20-minute maintenance in prone and supine position respectively.
Participants receive acupuncture treatment three times a week in the first four weeks and twice a week in the last four weeks.
Sham AcupunctureDevice
Hwato brand disposable placebo needles (with the handle identical to the needles in the acupuncture group and the body at a size 0.30 × 25 mm) and adhesive pads will be used. Acupoints of Ciliao, Huiyang, Shenshu, Guanyuan, Shuidao, Sanyinjiao, Zusanli, Taixi, Hegu, and Taichong will be used for every participants. Those with sleep or mood disorders will also use acupoints of Shangyintang, Shenmen and Neiguan. Those with tenderness points on the abdominal wall will also use Ashi points no more than five.
The needles will be inserted into adhesive pads without skin penetration. Needles will be lifted, thrusted and twirled gently for 3 times to mimic real acupuncture. No manipulation will be conducted during 20-minute maintenance in prone and supine position respectively.
Participants receive sham acupuncture treatment three times a week in the first four weeks and twice a week in the last four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Acupucnture | Experimental | Not described Receives: Device: Acupuncture |
| Sham Acupuncture | Sham comparator | Not described Receives: Device: Sham Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with at least 50% reduction of numerical rating scale (NRS) score on average pain.
Participants will rate their average chronic pelvic pain each week on a 0-10 NRS scale, where 0 refers to no pain and 10 refers to the worst pain imaginable. The final NRS score on average pain is defined as the mean of the average pain scores of the four weeks.
Measured: Weeks 5-8
Secondary outcomes (11)
Proportion of participants with at least 50% reduction of numerical rating scale (NRS) score on average pain.
Participants will rate their average chronic pelvic pain each week on a 0-10 NRS scale, where 0 refers to no pain and 10 refers to the worst pain imaginable. The final NRS score on average pain is defined as the mean of the average pain scores of the four weeks.
Measured: Weeks 1-4, 9-12, 13-16, 17-20.
Proportion of participants with at least 50% reduction of numerical rating scale (NRS) score on the worst pain.
Participants will rate their worst chronic pelvic pain each week on a 0-10 NRS scale, where 0 refers to no pain and 10 refers to the worst pain imaginable. The highest worst pain score of the four weeks will be taken as final NRS score on the worst pain.
Measured: Weeks 1-4, 5-8, 9-12, 13-16, 17-20.
The change from baseline in the numerical rating scale (NRS) score on average pain.
Participants will rate their average chronic pelvic pain each week on a 0-10 NRS scale, where 0 refers to no pain and 10 refers to the worst pain imaginable. The final NRS score on average pain is defined as the mean of the average pain scores of the four weeks.
Measured: Weeks 1-4, 5-8, 9-12, 13-16, 17-20.
The change from baseline in the numerical rating scale (NRS) score on the worst pain.
Participants will rate their worst chronic pelvic pain each week on a 0-10 NRS scale, where 0 refers to no pain and 10 refers to the worst pain imaginable. The highest worst pain score of the four weeks will be taken as final NRS score on the worst pain.
Measured: Weeks 1-4, 5-8, 9-12, 13-16, 17-20.
Proportion of participants with at least 30% reduction of numerical rating scale (NRS) score on average pain.
Participants will rate their average chronic pelvic pain each week on a 0-10 NRS scale, where 0 refers to no pain and 10 refers to the worst pain imaginable. The final NRS score on average pain is defined as the mean of the average pain scores of the four weeks.
Measured: Weeks 1-4, 5-8, 9-12, 13-16, 17-20.
Proportion of participants with at least 30% reduction of numerical rating scale (NRS) score on the worst pain.
Participants will rate their worst chronic pelvic pain each week on a 0-10 NRS scale, where 0 refers to no pain and 10 refers to the worst pain imaginable. The highest worst pain score of the four weeks will be taken as final NRS score on the worst pain.
Measured: Weeks 1-4, 5-8, 9-12, 13-16, 17-20.
The change from baseline in the interferes score of Brief Pain Inventory (BPI) short form.
The Brief Pain Inventory (BPI) short form assesses the degree to which the chronic pelvic pain interferes with activities over the prior week in terms of general activity, mood, walking ability, normal work (including housework), relations with other people, sleep and enjoyment of life using a 0- to 10-point scale (0 [Does not interfere] to 10 [Completely interferes]).
Measured: Weeks 4, 8, 12, 16, 20
The proportion of participants rates their overall improvement as "very much improved" or "much improved" based on the Patient Global Impression-Change (PGI-C) .
The Patient Global Impression-Change (PGI-C) is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse" or "very much worse".
Measured: Weeks 8 and 20
The change from baseline in the Female Sexual Function Index (FSFI) score.
The Female Sexual Function Index (FSFI) is a 19-item self-report inventory designed to assess female sexual function, which comprises six domains of desire, arousal, lubrication, orgasm, satisfaction, and pain.
Measured: Weeks 8 and 20
The change from baseline in the total and sub scores of Hospital Anxiety and Depression Scale (HADS).
Hospital Anxiety and Depression Scale (HADS) consists of 14 items, divided into two 7 item subscales to reflect a state of generalized anxiety and the depression. The respondent rates each item on a 4-point scale ranging from 0 (absence) to 3 (extreme presence).
Measured: Weeks 4, 8 and 20
The change from baseline in the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) questionnaire.
EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Questionnaire is used to measure health-related quality of life. It consists of five questions about mobility, self-care, usual activities, pain and discomfort, and anxiety and depression, and a visual analogue scale on the general health state during the day.
Measured: Weeks 4, 8 and 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start6 Mar 2022
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acupuncture, Chronic Pelvic Pain, WomanStudies 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, Investigator, Outcomes assessor
- Enrolment
- 216 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, Yuanjie Sun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223517
- Sponsor's protocol ID
- 2021-135-KY-01
- Status last verified
- Mar 2022
- First submitted
- 6 Jan 2022
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participant data and data dictionary will be available with publication until six months after publication. Formal request should be sent to puzhisun@163.com with a methodologically sound proposal. Researchers whose proposal has been approved will sign a data access agreement.
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupuncture for Chronic Pelvic Pain in Women: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05223517
- Acronym / sponsor ID
- 2021-135-KY-01
- Conditions
- Acupuncture, Chronic Pelvic Pain, Woman
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 6 Mar 2022 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 4 Feb 2022 (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.
The aim of the study is to assess the effects and safety of acupuncture for moderate to severe chronic pelvic pain in women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupucnture | Experimental | Device: Acupuncture |
| Sham Acupuncture | Sham comparator | Device: Sham Acupuncture |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- Cyclical chronic pelvic pain, such as only with dysmenorrhea.
- Endometriosis.
- Adenomyosis.
- Complex ovarian cyst.
- Accessory cyst >5cm.
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 |
|---|---|---|
| AcupunctureHwato brand disposable acupuncture needles (size 0.30 × 40 mm and 0.30 × 75 mm) and adhesive pads will be used. Acupoints of Ciliao, Huiyang, Shenshu, Guanyuan, Shuidao, Sanyinjiao, Zusanli, Taixi, Hegu, and Taichong will be used for every participants. Those with sleep or mood disorders will also use acupoints of Shangyintang, Shenmen and Neiguan. Those with tenderness points on the abdominal wall will also use Ashi points no more than five. The needles will be inserted to 60-70mm in Ciliao and Huiyang, 6-10 mm in Shenmen and 10-20mm in other acupoints through adhesive pads. Needles will be lifted, thrusted and twirled gently for 3 times (except for Ciliao) to achieve deqi sensation and manipulated every ten minutes during 20-minute maintenance in prone and supine position respectively. Participants receive acupuncture treatment three times a week in the first four weeks and twice a week in the last four weeks. | Device | Acupucnture |
| Sham AcupunctureHwato brand disposable placebo needles (with the handle identical to the needles in the acupuncture group and the body at a size 0.30 × 25 mm) and adhesive pads will be used. Acupoints of Ciliao, Huiyang, Shenshu, Guanyuan, Shuidao, Sanyinjiao, Zusanli, Taixi, Hegu, and Taichong will be used for every participants. Those with sleep or mood disorders will also use acupoints of Shangyintang, Shenmen and Neiguan. Those with tenderness points on the abdominal wall will also use Ashi points no more than five. The needles will be inserted into adhesive pads without skin penetration. Needles will be lifted, thrusted and twirled gently for 3 times to mimic real acupuncture. No manipulation will be conducted during 20-minute maintenance in prone and supine position respectively. Participants receive sham acupuncture treatment three times a week in the first four weeks and twice a week in the last four weeks. | Device | Sham Acupuncture |
Primary outcome
Proportion of participants with at least 50% reduction of numerical rating scale (NRS) score on average pain.
Time frame: Weeks 5-8
Participants will rate their average chronic pelvic pain each week on a 0-10 NRS scale, where 0 refers to no pain and 10 refers to the worst pain imaginable. The final NRS score on average pain is defined as the mean of the average pain scores of the four weeks.
11 secondary outcomes
Proportion of participants with at least 50% reduction of numerical rating scale (NRS) score on average pain.
Time frame: Weeks 1-4, 9-12, 13-16, 17-20.
Proportion of participants with at least 50% reduction of numerical rating scale (NRS) score on the worst pain.
Time frame: Weeks 1-4, 5-8, 9-12, 13-16, 17-20.
The change from baseline in the numerical rating scale (NRS) score on average pain.
Time frame: Weeks 1-4, 5-8, 9-12, 13-16, 17-20.
The change from baseline in the numerical rating scale (NRS) score on the worst pain.
Time frame: Weeks 1-4, 5-8, 9-12, 13-16, 17-20.
Proportion of participants with at least 30% reduction of numerical rating scale (NRS) score on average pain.
Time frame: Weeks 1-4, 5-8, 9-12, 13-16, 17-20.
Proportion of participants with at least 30% reduction of numerical rating scale (NRS) score on the worst pain.
Time frame: Weeks 1-4, 5-8, 9-12, 13-16, 17-20.
The change from baseline in the interferes score of Brief Pain Inventory (BPI) short form.
Time frame: Weeks 4, 8, 12, 16, 20
The proportion of participants rates their overall improvement as "very much improved" or "much improved" based on the Patient Global Impression-Change (PGI-C) .
Time frame: Weeks 8 and 20
The change from baseline in the Female Sexual Function Index (FSFI) score.
Time frame: Weeks 8 and 20
The change from baseline in the total and sub scores of Hospital Anxiety and Depression Scale (HADS).
Time frame: Weeks 4, 8 and 20
The change from baseline in the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) questionnaire.
Time frame: Weeks 4, 8 and 20
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Individual participant dataSharing planned: Yes. Deidentified participant data and data dictionary will be available with publication until six months after publication. Formal request should be sent to puzhisun@163.com with a methodologically sound proposal. Researchers whose proposal has been approved will sign a data access agreement.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Acupuncture, Chronic Pelvic Pain, Woman, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
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 15 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 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Yuanjie Sun, Medical doctor (86 18810337542, puzhisun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with at least 50% reduction of numerical rating scale (NRS) score on average pain. (time frame: Weeks 5-8). 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 22 Mar 2022; AzTrials last refreshed its copy on 31 Oct 2026.