A Prospective Randomized Clinical Trial to Investigate the Effect of Mechanical Stimulation on Mastectomy Scars
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Vancouver Scare Scale (VSS) to study scar appearance
研究概览
简要总结
The purpose of this study is to investigate the efficacy of mechanical stimulation on mastectomy scars in:
(i) alleviating scar appearance - pigmentation, vascularity, pliability and thickness, (ii) reducing shoulder morbidities, (iii) improving arm functions, and (iv) enhancing quality of life, in women with breast cancer after mastectomy.
详细描述
Background:
Breast cancer is common among women. After surgical interventions like mastectomies, women with breast cancer may suffer physical, emotional and psychosocial complications. Evidence suggests that comprehensive physiotherapy program, including patient education, manual techniques, therapeutic exercises and compression bandaging, is effective in managing the above complications. Scarring was frequently overlooked in past studies. Besides cosmetic issues, a post mastectomy scar may cause adverse physical, functional, and psychological outcomes. The effects of mechanical stimulation on mastectomy scars have not been well investigated yet.
Objectives:
To investigate the efficacy of mechanical stimulation in:
(i) alleviating scar appearance - pigmentation, vascularity, pliability and thickness, (ii) reducing shoulder morbidities, (iii) improving arm functions, and (iv) enhancing quality of life, in women with breast cancer after mastectomy.
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
- Single (Outcomes Assessor)
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
- •Women aged 18 years old or above with mastectomy performed in recent 6 weeks;
- •Able to attend physiotherapy treatment and follow-ups during the study period.
排除标准
- •Altered mental state for cooperation and informed consent;
- •Signs and symptoms of mastectomy scar infections or inflammations;
- •Unhealed mastectomy wounds;
- •History of lymphoedema;
- •Diagnosed bilateral breast cancers;
- •Unstable medical or cardiovascular conditions;
- •Pre-existing arm impairments/dysfunctions that will affect testing or exercising the affected arm;
- •Receiving radiotherapy during the study period;
- •Known sensitivity to mechanical stimulation;
- •Skin cancer on the treatment area;
- •Unclear cut margins of the cancer;
- •Known metastasis to other areas;
- •HIV positive.
研究组 & 干预措施
Conventional treatment group
Conventional treatment group will receive an educational session before commencement of the program. Twelve sessions of 40-minute remedial exercises, 5-minute warm up and 5-minute cool down exercises will be provided within a 6-week period (i.e., two sessions per week) to all subjects. No mechanical stimulation will be given.
干预措施: Conventional treatment (Other)
Mechanical stimulation group
A 10 minute mechanical stimulation program - 'Mechanical stimulation (LPG system; Cellu M6 Integral I), will be provided after each of the twelve sessions of conventional treatment.
干预措施: Mechanical stimulation (LPG system; Cellu M6 Integral I) (Other)
结局指标
主要结局
Vancouver Scare Scale (VSS) to study scar appearance
时间窗: 6 months
A scar scale to quantify scar appearance by observing the thickness, pliability, pigmentation and vascularity of mastectomy scar. The former two items were rated on ordical scales whereas the later two items in a descriptive manner. Total score ranged from 0 to 13.
Spectrophotometry to measure scar color
时间窗: 6 months
A spectrophotometer (Hunterlab Miniscan Ez4500S, USA) is used to measure level of lightness, redness and yellowness of the mastectomy scar versus adjacent normal skin. Level of redness indicated vascularization and pigmentation represented significance of melanin deposited in a scar.
次要结局
- Shoulder range by goniometry(6 months)
- Quality of life(6 months)
- Arm function(6 months)
- Grip strength by hand-held dynamometer(6 months)
- Numeric pain rating scale (NPS) to study pain over affected breast(6 months)
研究者
Ka Po Andrea LEUNG
Senior Physiotherapist
The Queen Elizabeth Hospital