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临床试验/NCT07837596
NCT07837596已完成不适用

YAŞ KUPA UYGULAMASININ AKUT AĞRI ŞİKAYETİ İLE BAŞVURAN HASTALARDA ANALJEZİK ETKİNLİĞİNİN ARAŞTIRILMASI

Ataturk University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年3月7日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Pain intensity measured by the Visual Analogue Scale (VAS)

研究概览

简要总结

This prospective randomized controlled trial evaluated the effectiveness and safety of adjunctive wet cupping therapy combined with standard pharmacological treatment in adults presenting to the emergency department with acute non-specific low back pain. A total of 80 adult patients were randomly assigned to receive either wet cupping therapy plus intravenous dexketoprofen or intravenous dexketoprofen alone. Pain intensity was assessed using the Visual Analogue Scale (VAS) at baseline and at 10, 20, and 30 minutes after treatment, as well as at 24 hours. Secondary outcomes included the need for rescue analgesia, analgesic consumption during the first 24 hours after discharge, patient satisfaction, and treatment-related adverse events. The study was designed to determine whether adding wet cupping therapy to standard pharmacological treatment provides additional pain relief and improves short-term clinical outcomes in patients with acute non-specific low back pain.

详细描述

This prospective, single-center, parallel-group, randomized controlled superiority trial was conducted in the Emergency Department of a tertiary-care university hospital between March and June 2022. The study was designed to evaluate whether adjunctive wet cupping therapy provides additional short-term analgesic benefit when

Adult patients aged 18 to 70 years presenting to the emergency department with acute non-specific low back pain were screened for eligibility. Patients were eligible if they voluntarily agreed to participate and had a baseline pain intensity of at least 4 on the Visual Analogue Scale (VAS). Patients were excluded if their low back pain was related to trauma, chronic low back pain, or a specific underlying pathological condition. Additional exclusion criteria included skin infection at the intended wet cupping site, pregnancy or breastfeeding, known bleeding disorders, use of anticoagulant or antithrombotic medications, clinically significant anemia or hematological disease, abnormal coagulation parameters or platelet counts, allergy to the study medication, hemodynamic instability, or inability to provide

A total of 80 participants were planned for enrolment and were randomly allocated in a 1:1 ratio to either the intervention group or the control group. The intervention group received a single session of wet cupping therapy in addition to standard pharmacological treatment, while the control group received standard pharmacological treatment alone. All participants received 50 mg intravenous dexketoprofen trometamol diluted in 100 mL normal saline and administered over approximately 5 minutes immediately after enrolment. Participants whose pain remained clinically significant, defined as a VAS score greater than 4 at 30 minutes after treatment, received rescue analgesia with intravenous fentanyl at a dose of 1 mcg/kg diluted in 100 mL isotonic saline and administered over approximately 5 minutes.

Wet cupping therapy was performed concurrently with standard pharmacological treatment by trained healthcare personnel under sterile conditions. The intended treatment sites were three predefined anatomical locations: one point in the posterior cervicothoracic region corresponding to the DU14 acupuncture point and two bilateral paraspinal points corresponding to the BL25 region. The patient was positioned upright and the treatment sites were disinfected with 10% povidone-iodine solution. Dry cupping was initially applied for approximately 4-5 minutes using No. 7 cups to create negative pressure. Following removal of the cups, superficial skin incisions approximately 1 mm in depth and 1-3 mm in length were made u

The primary outcome was pain intensity measured using a 10-cm Visual Analogue Scale, with 0 representing no pain and 10 representing the worst imaginable pain. Pain intensity was assessed before treatment and at 10, 20, and 30 minutes after completion of the intervention, as well as at 24 hours after treatment. Secondary outcomes included the requirement for rescue analgesia within the first 30 minutes after treatment, total analgesic consumption during the first 24 hours after discharge, patient satisfaction, and

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults aged 18 to 70 years presenting to the Emergency Department with acute non-specific low back pain
  • •Voluntary agreement to participate
  • •Baseline Visual Analogue Scale (VAS) pain score of ≥4
  • •Ability to provide reliable informed consent

排除标准

  • •Low back pain secondary to trauma, chronic low back pain, or a specific underlying pathological condition
  • •Skin infection at the intended wet cupping site
  • •Pregnancy or breastfeeding
  • •Known bleeding disorders
  • •Use of anticoagulant or antithrombotic medications
  • •Clinically significant anemia or hematological disease
  • •Abnormal coagulation parameters or platelet counts
  • •Allergy to the study medication
  • •Hemodynamic instability
  • •Inability to provide reliable informed consent because of impaired orientation or cooperation

研究组 & 干预措施

Wet Cupping Therapy Group

Experimental

Participants in this group received a single session of wet cupping therapy in addition to standard pharmacological treatment with intravenous dexketoprofen.

干预措施: Wet Cupping Therapy (Behavioral)

Wet Cupping Therapy Group

Experimental

Participants in this group received a single session of wet cupping therapy in addition to standard pharmacological treatment with intravenous dexketoprofen.

干预措施: Dexketoprofen (Drug)

Control Group

Active Comparator

Participants in this group received standard pharmacological treatment with intravenous dexketoprofen alone.

干预措施: Dexketoprofen (Drug)

结局指标

主要结局

Pain intensity measured by the Visual Analogue Scale (VAS)

时间窗: Baseline, 10, 20, and 30 minutes after treatment, and 24 hours after treatment

Pain intensity was assessed using a 10-cm Visual Analogue Scale (VAS), with 0 representing no pain and 10 representing the worst imaginable pain. Pain intensity was measured at baseline (before treatment), and at 10, 20, and 30 minutes after completion of the intervention, as well as at 24 hours after treatment.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Murat Kösedağ

Biochemistry Specialist

Ataturk University

研究点 (1)

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