Acupuncture for Chronic Pelvic Pain

NCT05223517 | Unknown

• 1 other identifier: 2021-135-KY-01
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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.

Conditions

Acupuncture, Chronic Pelvic Pain, Woman

Outcome Measures

Primary Outcomes (1)

• 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.

  Weeks 5-8

Secondary Outcomes (11)

• Proportion of participants with at least 50% reduction of numerical rating scale (NRS) score on average pain.

  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.

  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.

  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.

  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.

  Weeks 1-4, 5-8, 9-12, 13-16, 17-20.

Other Outcomes (6)

• Expectance assessment

  Baseline

• Assessment of belief in acupuncture

  Baseline, week 4, week 8

• Blinding assessment

  Within 5 minutes after either treatment in week 8

Study Arms (2)

Acupucnture

EXPERIMENTAL

Device: Acupuncture

Sham Acupuncture

SHAM COMPARATOR

Device: Sham Acupuncture

Interventions

Acupuncture DEVICE

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.

Acupucnture

Sham Acupuncture DEVICE

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.

Sham Acupuncture

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Central Study Contacts

Yuanjie Sun, Medical doctor

CONTACT

86 18810337542; puzhisun@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: February 4, 2022
• Study Start: March 6, 2022
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be available with publication until until six months after publication.
• 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.

Locations

CN (1)