Effects of Photobiomodulation on Neuropathic Pain and Sensation Post-mastectomy: a
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Cutaneous Testing using protocol by Cruccu and Truini. (Cruccu G, Truini A. A review of Neuropathic Pain: From Guidelines to Clinical Practice. Pain Ther. 2017;6(Suppl 1):35-42. doi:10.1007/s40122-017-0087-0)
研究概览
简要总结
The goal of this case study is to examine the effects of Photobiomodulation (PBM) on neuropathic pain and sensation post-mastectomy in one female participant. Neuropathic pain and somatosensation will be primary measures, along with strength, range of motion testing, and measures of quality of life in response to exposure to PBM for 6 weeks.
详细描述
The goal of this case study is to examine the effects of Photobiomodulation (PBM) on neuropathic pain and sensation post-mastectomy in one female participant.
The main question[s] it aims to answer are:
- Will there be a difference in subjective neuropathic pain reported after application of PBM using red and near-infrared wavelengths?
- If a difference in symptoms is discovered, how many sessions were administered before such difference was noted?
- Will there be an observed difference in sensation assessment after application of PBM using red and near-infrared wavelengths?
- Will there be an observed difference on upper extremity mobility following application of PBM using red and near-infrared wavelengths?
- Will there be a subjective difference in quality-of-life following application of PBM using red and near-infrared wavelengths?
Participants will be asked to participate in:
- Initial sensation, range of motion, strength, pain, and quality of life assessments.
- Observation and demonstration of the PBM application with a study investigator present.
- Application of the PBM device to both sides of the chest over the breast tissue for a total of 30 seconds 3 times a week for 6 weeks in the participant's home environment without a study investigator present.
- Documentation of pain and skin observation/sensation after each treatment session.
- Follow-up assessments of sensation, range of motion, strength, pain, and quality of life at the end of week 6 after all PBM treatments have been conducted.
- Weekly monitoring of pain, and skin observation/sensation during weeks 7-10 in the absence of treatment intervention.
- Follow-up telephone calls by a study investigator during weeks 7-10.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Status-post mastectomy due to clinical diagnosis of breast cancer
- •Physician approval for participation in study
- •Independent with all mobility
- •Independent with cognitive decision-making
排除标准
- •Active Malignancy
- •Active Infection
结局指标
主要结局
Cutaneous Testing using protocol by Cruccu and Truini. (Cruccu G, Truini A. A review of Neuropathic Pain: From Guidelines to Clinical Practice. Pain Ther. 2017;6(Suppl 1):35-42. doi:10.1007/s40122-017-0087-0)
时间窗: Up to 10 weeks
Tactile sensation of light touch (Aβ nerve fibers) will be assessed using a cotton ball, pinprick sensation (Aδ nerve fibers) using a wooden cocktail stick, thermal sensation (Aδ and C nerve fibers) using warm and cold objects, and vibration (Aβ nerve fibers) using a tuning fork.
Semmes Weinstein Monofilament Testing
时间窗: Up to 10 weeks
Light touch sensation assessment using monofilaments of different diameters
Visual Analog Scale for Pain
时间窗: Up to 10 weeks
Pain rating on a 0 to 10 scale
次要结局
- The Quick Dash Outcome Measure(Up to 10 weeks)
- Patient-Reported Outcome Measures Information System (PROMIS) 29 + 2 Profile Measure Profile v2.1(Up to 10 weeks)
- Range of motion assessment(Up to 10 weeks)
- Strength testing (manual muscle testing and dynamometry)(Up to 10 weeks)
研究者
Kim Dao
Assistant Professor
Tufts University