Clinical efficacy and mechanism of acupuncture in the treatment of osteoarthralgia caused by aromatase inhibitors in breast cancer
- Conditions
- Osteoarthralgia due to aromatase inhibitors in breast cancer
- Registration Number
- ITMCTR2200006739
- Lead Sponsor
- Beijing Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
(1) Patients with histopathological confirmed (stage I-III) primary breast cancer, immunohistochemistry showing estrogen receptor and/or progesterone receptor positive; (2) be between 35 and 75 years old; (3) No metastasis to other locations occurred after breast cancer surgery, and systemic symptoms have recovered from the side effects of surgery and the reaction of radiotherapy and chemotherapy; (4) Have been taking aromatase inhibitors for more than 30 days and plan to continue to use them for at least 1 year; (5) Single or multiple bone and joint pain symptoms, and the most severe pain item (BPI-WP) score in the Abbreviated Pain Scale (BPI) is greater than 3 points; (6) Those who voluntarily sign the informed consent form.
(1) Currently receiving other topical analgesics; (2) Those suffering from autoimmune diseases and other non-AIs-induced joint pain; (3) Combining severe primary diseases such as liver, kidney, hematopoietic system, opioid Analgesics, sedative-hypnotics and alcohol abuse history; (4) patients with severe acupuncture intolerance; (5) pregnant and lactating women; (6) patients diagnosed with metastatic breast cancer; (7) ) received acupuncture and closed treatment in the last 3 months; (8) patients who were unable to participate in the follow-up and were unable to participate in the six-month follow-up; (9) are currently participating in other clinical trials related to AIA.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in scores for the Brief Pain Scale (BPI) Most Severe Pain Item (BPI-WP) after 6 weeks of treatment; Mechanistic inflammatory indicators: changes in the content of pro-inflammatory cytokines (IL-1ß, IL-6, TNF-a) after 6 weeks of treatment.;
- Secondary Outcome Measures
Name Time Method Pain indicators; Quality of life indicators;