Acupuncture (Dry-needling) as Treatment of Post-herpetic Neuralgia: A Double-blinded Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Dermal pain [LEVEL OF PAIN]
研究概览
简要总结
The aim of this study is to perform the first RCT investigating the possible effect of superficial dry-needling (SDN) - a special kind of acupuncture used for PHN. The participants will be divided into two groups. Group A, the intervention group will receive SDN in the area of pain. Group B, the control group will receive a sham procedure.
详细描述
The aim of this study is to investigate the possible effect of SDN on PHN. The study population consists of patients with chronic pain after herpes zoster.
The study is a controlled double-blinded randomized study. The participants will be divided into two groups, group A, the intervention group, will receive SDN in the area of pain. Group B, the control group will receive a sham procedure. The procedure will take place at the out-patient clinic at Odense University Hospital. The plan is to include 40 patients (20 in each group).
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants will not be aware of the treatment given. The randomization will take place right before the procedure begins. The treatment will be given to the skin covering the spine and the patients will be placed in the supine position. They will therefore not know whether or not they are receiving the actual acupuncture or the sham procedure.
The investigator will not be present at the procedures and will not have access to patients records and data until after the trial is complete.
The outcomes are measured using validated questionnaires. They will be assessed by the investigator at the time of project completion.
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 50-75 years.
- •Pain in the dermatomal area of the previous outbreak of HZ.
- •Pain located to a dermatome originating from the thoracic or lumbar spine.
- •At least six months since the outbreak.
- •Understands the purpose of the study and is able to give consent.
排除标准
- •A psychiatric illness affecting participation in the study.
- •Active cancer
- •Pregnancy
结局指标
主要结局
Dermal pain [LEVEL OF PAIN]
时间窗: 1 month
Questionnaire. Visual Analogue Scale (VAS). Patients will be asked to report on their average and maximum level of pain on a scale from 0-10.
次要结局
- Neuropathic pain [LEVEL OF PAIN](1 month)
- Quality of life [QUALITY OF LIFE/ SATISFACTION](1 month)
研究者
Martin Sollie
Principal investigator, M.D, Dept. of Plastic and Reconstructive Surgery Affiliation: Odense University Hospital Collaborators:
Odense University Hospital