Acupuncture for Chronic Pelvic Pain
- Conditions
- Acupuncture, Chronic Pelvic Pain, Woman
- Interventions
- Device: Sham AcupunctureDevice: Acupuncture
- Registration Number
- NCT05223517
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 216
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham Acupuncture Sham Acupuncture - Acupucnture Acupuncture -
- Primary Outcome Measures
Name Time Method Proportion of participants with at least 50% reduction of numerical rating scale (NRS) score on average pain. 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.
- Secondary Outcome Measures
Name Time Method 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. 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. Weeks 1-4, 5-8, 9-12, 13-16, 17-20. 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 the worst pain. Weeks 1-4, 5-8, 9-12, 13-16, 17-20. 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. Weeks 1-4, 5-8, 9-12, 13-16, 17-20. 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 average pain. Weeks 1-4, 5-8, 9-12, 13-16, 17-20. 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. Weeks 1-4, 5-8, 9-12, 13-16, 17-20. 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. Weeks 4, 8, 12, 16, 20 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) . Weeks 8 and 20 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. Weeks 8 and 20 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). Weeks 4, 8 and 20 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. Weeks 4, 8 and 20 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.
Trial Locations
- Locations (1)
China Academy of Chinese Medical Sciences
🇨🇳Beijing, Beijing, China