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临床试验/NCT07340307
NCT07340307招募中不适用

Application of Wrist-Ankle Acupuncture in Patients With Different Types of Pain Following Perianal Surgery: A Prospective Cohort Study

The Affiliated Hospital of Putian University1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2025年10月25日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
58
试验地点
1
主要终点
Postoperative pain intensity

研究概览

简要总结

This study is a prospective clinical observation designed to evaluate the analgesic effect of wrist-ankle acupuncture in patients with different types of pain after perianal surgery, as well as its applicability. A total of 60 eligible postoperative patients were enrolled, with inclusion criteria including age 18-75 years, postoperative Visual Analog Scale (VAS) score ≥4, clear consciousness, and signed informed consent. Exclusion criteria included pregnancy, history of needle fainting, skin lesions at the wrist or ankle, severe systemic diseases, inability to cooperate with follow-up, or participation in other clinical trials. Patients were divided into two groups according to the nature of pain: Group A (sphincter spasm pain, n=30) and Group B (acute incisional pain, n=30). All patients received routine postoperative care (including intravenous flurbiprofen infusion, traditional Chinese medicine soaking, and pain education), and wrist-ankle acupuncture was administered when pain intensity (Verbal Rating Scale, VRS) reached ≥4. The acupuncture method involved superficial subcutaneous insertion in zones 1 and 6 of both lower limbs using disposable sterile needles (0.25 mm × 25 mm). Needles were retained for 0.5-1 hour, once daily, with the treatment course adjusted based on symptom relief. If the VAS score remained ≥4 at 30 minutes post-treatment, adjunctive analgesic medication was administered as prescribed. Observation indicators included postoperative VRS scores, reduction in VAS scores at 5 and 30 minutes after wrist-ankle acupuncture treatment, frequency of analgesic medication use within the first 3 postoperative days, and the Clinical Postoperative Urinary Retention (POUR) score at 24 hours post-surgery. By comparing data between the two groups, the analgesic effect of wrist-ankle acupuncture was analyzed, and the influence of postoperative pain on the occurrence of urinary retention was explored.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged between 18 and 75 years;
  • Patients who underwent perianal surgery;
  • Visual Analog Scale (VAS) score ≥4;
  • Clear consciousness with the ability to articulate their sensations;
  • Voluntary participation with signed informed consent.

排除标准

  • Pregnant or lactating patients;
  • Patients with a history of needle fainting or needle phobia;
  • Patients with incomplete skin integrity at the wrist or ankle;
  • Patients with comorbid systemic diseases, such as cardiac insufficiency or coagulation disorders;
  • Patients unable to cooperate with follow-up;
  • Patients currently participating in other clinical trials that may influence the outcomes of this study.

结局指标

主要结局

Postoperative pain intensity

时间窗: During the hospitalization period

Pain assessment was conducted using the Visual Analog Scale (VAS). A 10-cm horizontal line was drawn on paper, with one end marked as "0" indicating "no pain" and the opposite end marked as "10" indicating "severe pain." The intermediate sections represented varying degrees of pain intensity. Patients were instructed to mark a point on the line based on their subjective perception of pain. Assessments were performed at 24 hours postoperatively, as well as at 5 minutes and 30 minutes after the administration of wrist-ankle acupuncture therapy. The reduction in Visual Analogue Scale(VAS) scores was recorded accordingly.

次要结局

  • Analgesic Medication Frequency(During the hospitalization period)
  • Clinical Postoperative Urinary Retention (POUR) Score(7days postoperativelyacupuncture administration.)

研究者

发起方
The Affiliated Hospital of Putian University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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