Acupuncture for Female With Non-cyclic Chronic Pelvic Pain

Chronic Pelvic Pain Clinical Trial

Official title:

Efficacy of Acupuncture for Female With Non-cyclic Chronic Pelvic Pain: a Three-armed Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04553562
• Other study ID #: 2019-248-KY
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2021
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Zhishun Liu, PhD
• Phone: 86-010-88002331
• Email: liuzhishun[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. A three-arm randomized controlled trial (RCT) using acupuncture, sham acupuncture and waiting list with a total sample of 150 will be conducted.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Chronic Pelvic Pain
• Pelvic Pain

Intervention

Device:
• Acupuncture
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 acupuncture
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blinding assessment	To test the success of blinding, participants in the acupuncture group and the SA group will be asked to reply to the following question at the 6th week of treatment (sessions 18): "Do you think you have received traditional acupuncture in the past weeks?" The participants will be able to choose one of the following options as the answer: "Yes", "No" or "Unclear".	Week 6
Other	Safety assessment	We will handle and document the adverse events (AEs) using the standard operating procedures for monitoring and reporting all AEs. According to their potential association with the treatment, AEs will be categorized as treatment-related or non-treatment-related within 24 hours after their occurrence. Treatment-related AEs include pain, haematoma, localized infection, broken needle, fainting, nausea, headache, dizziness, insomnia, vomiting, or palpitations during or after treatment. In addition, adverse events that are irrelevant to the treatment will be recorded during the study period.	Week 0 to 30
Other	Expectation of improvement assessment	Patients choosing "improved" in the expectation assessment will be asked: "To what extent do you think your pelvic pain will be helped after acupuncture treatment?" Participants will choose the answer from the following options: a great degree, a moderate degree, a small degree, unclear.	Baseline
Other	Trust evaluation of acupuncture therapy	Patients choosing "improved" in the expectation assessment will be asked: "To what extent do you think your pelvic pain will be helped after acupuncture treatment?" Participants will choose the answer from the following options: a great degree, a moderate degree, a small degree, unclear.	Baseline and week 6
Primary	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.	Week 6, 18 and 30
Secondary	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.	Week 6, 18 and 30
Secondary	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.	Week 6, 18 and 30
Secondary	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.	Week 6, 18 and 30
Secondary	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.	Week 6, 18 and 30
Secondary	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.	Week 6, 18 and 30
Secondary	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.	Week 6, 18 and 30
Secondary	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.	Week 6, 18 and 30
Secondary	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.	Week 6, 18 and 30
Secondary	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.	Week 6, 18 and 30
Secondary	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.	Week 6, 18 and 30