Pain management in patients with metastatic bone cancer based on the theory of 'wrist-ankle acupuncture': study protocol for a randomized controlled trial

Phase 1

Recruiting

• Conditions: metastatic bone cancer

• Registration Number: ITMCTR2100004466
• Lead Sponsor: Affiliated Hospital of Chengdu University of TCM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) Patients with bone metastases from malignant tumors with a clear diagnosis, with an expected survival period of more than 1 month;
(2) According to the 2015 National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Adult Cancer Pain, the etiology of cancer pain: directly caused by the tumor, including the pain caused by the primary tumor and/or metastatic tumor; tumor-related Pain; pain caused by tumor treatment;
(3) Bone pain related to tumor bone metastasis: including pain mainly in the pelvis, clavicle, spine, ribs and limbs, etc. and cancer pain NRS (Pain Numerical Rating Method) >= 4 points;
(4) Between the ages of 30 and 75 years;
(5) Kamofsky Performance Status( KPS)>= 30;
(6) Normal language skills, ability to judge their own pain and general conditions, good compliance, and ability to evaluate pain cooperatively.

Exclusion Criteria

(1) Combined with pain caused by non-bone metastatic cancer;
(2) Patients with severe pain before treatment, NRS >= 9 points, and a large amount of morphine that still cannot relieve the pain;
(3) Patients with severe heart, liver, kidney, and hematopoietic insufficiency;
(4) Patients who have recently received radiotherapy;
(5) Poor compliance, uncooperativeness, fainting or fear or resistance to acupuncture treatment;
(6) Women who are pregnant or breastfeeding, or those who have mental retardation or who have hearing, mental, cognitive, or consciousness disorders, and those who have difficulty in judging pain by themselves;
(7) Other clinical trials are under study.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain treatment effect score;

Secondary Outcome Measures

Name	Time	Method
Safety evaluation;Pain treatment related time evaluation ;Quality of life assessment ;Equivalent morphine dosage;