A Placebo-Controlled Trial of Thermal Biofeedback Assisted Relaxation for the Treatment of Diabetic Neuropathy: An Evaluation of Outcomes and Mechanisms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- Subjective Pain
研究概览
简要总结
The purpose of this study is to examine potential treatment options for a condition in diabetics that causes tingling, pain, and numbness in the hands and /or feet, also known as diabetic peripheral neuropathy.
详细描述
Participants attend 6 sessions lasting from 35 minutes to 2 hours (depending on the session). Sessions can be scheduled once or twice per week. Sessions involve a walking task, filling out questionnaires, and having temperature of hands and feet monitored. This study involves no drugs, blood draws, or any other invasive procedures. Participants are urged to continue the treatment of diabetes and diabetic neuropathy as directed by their physician for the duration of their involvement with the study. After 3 months, a packet of questionnaires will be mailed with a stamped addressed envelope to be returned.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical Diagnosis of Diabetic Neuropathy in Hands and/or Feet
- •Must have some sensation left in hands and feet
排除标准
- •Any partial or total amputation of an limb or digit
- •Any previous experience with biofeedback
- •Prior treatment for alcohol abuse
- •Severe Psychopathology
研究组 & 干预措施
Thermal Biofeedback Assisted Relaxation
干预措施: Thermal Biofeedback Assisted Relaxation (Behavioral)
Discussion
干预措施: Discussion with therapist (Behavioral)
结局指标
主要结局
Subjective Pain
时间窗: Change in subjective pain rating from baseline to end of intervention
次要结局
- Perceived Control(Change from mid-intervention (visit 4) to end of intervention)
- Temperature(Change within each session and across sessions from baseline to end of intervention)
研究者
Angela Fidler Pfammatter, PhD
Postdoctoral Fellow
Northwestern University