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Acupuncture for Chronic Pelvic Pain

Primary Purpose

Acupuncture, Chronic Pelvic Pain, Woman

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Acupuncture
Sham Acupuncture
Sponsored by
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acupuncture, Chronic Pelvic Pain, Woman

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Cyclical chronic pelvic pain, such as only with dysmenorrhea.
  • Endometriosis.
  • Adenomyosis.
  • Complex ovarian cyst.
  • Accessory cyst >5cm.
  • Uterine fibroids >5cm.
  • 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.

Sites / Locations

  • China Academy of Chinese Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Acupucnture

Sham Acupuncture

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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]).
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".
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.
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).
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.

Full Information

First Posted
January 6, 2022
Last Updated
March 8, 2022
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05223517
Brief Title
Acupuncture for Chronic Pelvic Pain
Official Title
Effect of Acupuncture for Chronic Pelvic Pain in Women: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 6, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
December 2024 (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
No

5. Study Description

Brief Summary
The aim of the study is to assess the effects and safety of acupuncture for moderate to severe chronic pelvic pain in women.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acupuncture, Chronic Pelvic Pain, Woman

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupucnture
Arm Type
Experimental
Arm Title
Sham Acupuncture
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Acupuncture
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham Acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of participants with at least 50% reduction of numerical rating scale (NRS) score on average pain.
Description
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.
Time Frame
Weeks 5-8
Secondary Outcome Measure Information:
Title
Proportion of participants with at least 50% reduction of numerical rating scale (NRS) score on average pain.
Description
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.
Time Frame
Weeks 1-4, 9-12, 13-16, 17-20.
Title
Proportion of participants with at least 50% reduction of numerical rating scale (NRS) score on the worst pain.
Description
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.
Time Frame
Weeks 1-4, 5-8, 9-12, 13-16, 17-20.
Title
The change from baseline in the numerical rating scale (NRS) score on average pain.
Description
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.
Time Frame
Weeks 1-4, 5-8, 9-12, 13-16, 17-20.
Title
The change from baseline in the numerical rating scale (NRS) score on the worst pain.
Description
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.
Time Frame
Weeks 1-4, 5-8, 9-12, 13-16, 17-20.
Title
Proportion of participants with at least 30% reduction of numerical rating scale (NRS) score on average pain.
Description
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.
Time Frame
Weeks 1-4, 5-8, 9-12, 13-16, 17-20.
Title
Proportion of participants with at least 30% reduction of numerical rating scale (NRS) score on the worst pain.
Description
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.
Time Frame
Weeks 1-4, 5-8, 9-12, 13-16, 17-20.
Title
The change from baseline in the interferes score of Brief Pain Inventory (BPI) short form.
Description
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]).
Time Frame
Weeks 4, 8, 12, 16, 20
Title
The proportion of participants rates their overall improvement as "very much improved" or "much improved" based on the Patient Global Impression-Change (PGI-C) .
Description
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".
Time Frame
Weeks 8 and 20
Title
The change from baseline in the Female Sexual Function Index (FSFI) score.
Description
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.
Time Frame
Weeks 8 and 20
Title
The change from baseline in the total and sub scores of Hospital Anxiety and Depression Scale (HADS).
Description
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).
Time Frame
Weeks 4, 8 and 20
Title
The change from baseline in the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) questionnaire.
Description
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.
Time Frame
Weeks 4, 8 and 20
Other Pre-specified Outcome Measures:
Title
Expectance assessment
Description
Participants will be asked what do you think the condition of chronic pelvic pain will be in two month?
Time Frame
Baseline
Title
Assessment of belief in acupuncture
Description
Participants will be asked do you think acupuncture will help to treat your chronic pelvic pain.
Time Frame
Baseline, week 4, week 8
Title
Blinding assessment
Description
Participants will be ask do you think you have received traditional acupuncture in the past 8 weeks.
Time Frame
Within 5 minutes after either treatment in week 8
Title
Adherence assessment
Description
Adherence will be assessment via counting treatment sessions. Those complete over 80% treatment sessions will be defined as of good adherence.
Time Frame
Weeks 1-8
Title
Proportion of participants using rescue medicine.
Time Frame
Through study completion, an average of 3 years
Title
Proportion of participants using concomitant medicine or therapy that might impact chronic pelvic pain.
Time Frame
Through study completion, an average of 3 years

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: 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. Exclusion Criteria: Cyclical chronic pelvic pain, such as only with dysmenorrhea. Endometriosis. Adenomyosis. Complex ovarian cyst. Accessory cyst >5cm. Uterine fibroids >5cm. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuanjie Sun, Medical doctor
Phone
86 18810337542
Email
puzhisun@163.com
Facility Information:
Facility Name
China Academy of Chinese Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuanjie Sun, PhD
Phone
86 18810337542
Email
puzhisun@163.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
The data will be available with publication until until six months after publication.
IPD Sharing Access Criteria
Formal request should be sent to puzhisun@163.com with a methodologically sound proposal. Researchers whose proposal has been approved. Researchers whose proposal has been approved will sign a data access agreement.

Learn more about this trial

Acupuncture for Chronic Pelvic Pain

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