ACTRN12608000503325尚未招募未知
A Proof of Concept Study of the Effect of Low Intensity Laser Therapy (LILT) in the Management of Wound Pain
Royal District Nursing Service (RDNS) Helen Macpherson Smith Institute of Community Health0 个研究点目标入组 60 人开始时间: 2008年9月30日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 120 Years(—)
- 性别
- All
入选标准
- •1-The client has a chronic wound on entire leg (of a maximum size of 10cms in diameter and depth of 2cm) which may be of a diabetic origin, pressure ulcer, venous, arterial and mixed aetiology ulcers
- •2.The wound is older than six weeks from its inception.
- •3.Wound healing is by secondary intention; Wound healing is delayed and occurs by a process of granulation, contraction and epithelialisation (Carville, 2001)”
- •Unresolved Pain
- •The client reports unresolved pain:
- •4.The client has pain associated with a chronic wound that has not responded to standard pain management.
- •4.1. Pain is measured on a pain scale of 0-10 with 0 indicating the absence of pain and 10 indicating the worst pain the client can imagine. Clients are eligible if they report pain as being 1 or more on this scale.
- •4.2. Pain is to be evaluated as unresolved if any level of pain (1 or greater on the pain scale) persists after they have received pain management.
- •5. The pain must be located within the wound (plus or minus pain in areas other than the wound i.e. the leg or associated with the wound i.e. when walking the wound is painful).
- •6. The pain is experienced at times other than during dressing changes.
排除标准
- •1.The client has been diagnosed with and/or is receiving treatment for a malignancy
- •2.The client’s health professional or appropriate wound specialist does not support the inclusion of the client in the Randomised Control Trial.
- •3.Client is on a fee for service program inappropriate for inclusion in the study.
- •4.The client has any planned absences over the coming three months.
- •5. Client does not agree to attend the Care and Assessment Centre three times weekly (two times weekly for control group) for six weeks and for 2 weekly review at 8, 10 and 12 weeks.
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