A randomized controlled trial for acupuncture combined with conventional therapy in the treatment of pain caused by prostate cancer: Study protocol clinical trial (SPIRIT compliant)

针灸联合常规疗法治疗前列腺癌疼痛的随机对照试验:临床试验研究方案(符合SPIRIT标准)

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Abstract

INTRODUCTION: Prostate cancer refers to an epithelial malignant tumor that occurs in the prostate area. In recent years, with the improvement of people's living standards, the incidence of prostate cancer has gradually increased, which has greatly affected people's life and health and quality of life. Acupuncture has its unique advantages in treating cancer pain. We will evaluate the efficacy and safety of acupuncture and moxibustion in the treatment of pain caused by prostate cancer using a clinical randomized parallel control method. METHODS/DESIGN: This pragmatic randomized controlled trial will recruit 120 patients who are diagnosed with prostate cancer. Simple randomization to conventional drug treatment with a 1:1 allocation ratio will be used. Based on the patient's pain location and the primary lesion, the acupuncture needle insertion position was determined according to the principle of local selection of acupoints. All participants will continue to receive conventional drug treatment. DISCUSSION: This trial may provide evidence regarding the clinical effectiveness, safety, and cost-effectiveness of acupuncture for pain caused by prostate cancer. TRIAL REGISTRATION: ClinicalTrials.gov, ChiCTR2000029801, Registered on 14 February 2020.

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