Treatment of Postmastectomy Pain Syndrome With Fat Grafting: A Double-blinded Randomized Controlled 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
- Pain on visual analog scale (VAS) 0-10
研究概览
简要总结
This study evaluates the possible beneficial effect of fat grafting for post mastectomy pain syndrome. Half of patients will receive fat grafting and the other half of patients will receive sham.
详细描述
Several studies have suggested that fat grafting can alleviate pain in post mastectomy pain syndrome. These studies however have either been in the form of case series or unblinded studies with great risk of bias.
It is believed that fat grafting with its content of adipose-derived stem cells can modulate the scar tissue upon grafting and hereby decrease pain.
In this study patients will be randomized to either fat grafting or a sham procedure where they undergo the same liposuction but no fat grafting, only injection of saline instead of fat.
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, Care Provider, Outcomes Assessor)
盲法说明
During general anesthesia, patients are randomized to either fat grafting or sham grafting with only saline. All patients undergo the same liposuction. Participants are blinded, care providers postoperatively are blinded. The surgeon performing the procedure is not blinded. The outcome assessors 3 and 6 months postoperatively are blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Treated for breast cancer
- •Pain in the breast cancer treated area on the breast or axilla.
- •Pain present at least 4 days a week with an intensity above 3 on VAS.
- •Duration longer than 3 months
- •Recurrence free for minimum 6 months
- •Understand the nature of the study and can give informed consent
排除标准
- •Psychiatric condition that can affect participation.
- •Recurrence of breast cancer at any time.
- •Other indication for fat grafting other than pain treatment.
- •Breast reconstruction with flap
结局指标
主要结局
Pain on visual analog scale (VAS) 0-10
时间窗: 6 months
Pain on visual analog scale (VAS) 0-10
次要结局
- Neuropathic Pain Symptom Inventory(3 and 6 months)
- Use of pain medication(3 and 6 months)
- Pain on visual analog scale (VAS) 0-10(3 months)
研究者
Martin Sollie
Doctor
Odense University Hospital