Pilot Study of Mindfulness Meditation and Transcutaneous Nerve Stimulation (TENS) in Persons Living With HIV-related Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- Change from Baseline Pain Intensity at 7 weeks
研究概览
简要总结
This study is to explore the effects of transcutaneous nerve stimulation (TENS) and mindfulness meditation in persons living with HIV (PLHIV) and painful neuropathy in the feet.
详细描述
The overall goal of this study is to conduct an interventional pilot trial of mindfulness meditation and transcutaneous nerve stimulation (TENS) to mitigate the symptoms and improved function in persons living with HIV (PLHIV) and painful neuropathy in the feet. .
The investigators aim to determine the feasibility and effects of (1) mindfulness meditation or (2) transcutaneous nerve stimulation (TENS) on clinical and functional outcomes in participants with HIV-associated painful distal sensory polyneuropathy in the feet. This aim will be achieved with a randomized control pilot trial with 3 groups: TENS group, Mindfulness Mediation Group, and Usual Treatment (Control) group. The interventions will be performed at home over a period of 6 weeks.
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)
盲法说明
co-investigators involved with measurement for the interventional phase will not know which of the 3 groups a participant was randomized to
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of HIV infection currently treated with antiretroviral therapy (ART)
- •cluster of differentiation 4 cell (CD4 cell) count of at least 200 cells/mm3
- •18-64 years of age
- •able to read and write in English
- •means to travel to a study site
- •presence of peripheral neuropathy symptoms in feet
- •average daily self-reported pain in the feet of at least 3/10 on a 0-10 numerical pain scale
- •pain in the feet present for at least the past 3 months
- •no changes in medications used to manage pain in the past 4 weeks
- •no use of TENS or mindfulness meditation in the prior 6 months
- •availability of a mobile phone to receive text messages over the course of the intervention period
排除标准
- •current opportunistic infection(s)
- •cluster of differentiation 4 cell (CD4 cell) count <200 cells/mm3
- •uncontrolled psychiatric disorder
- •wounds or sores on the feet
- •musculoskeletal or neurological conditions (other than distal sensory neuropathy) that may affect gait
- •pregnancy
研究组 & 干预措施
Mindfulness Meditation
6 weeks of daily mindfulness meditation (guided by audio recordings) performed at home
干预措施: Mindfulness Meditation (Behavioral)
Transcutaneous nerve stimulation (TENS)
6 weeks of daily TENS treatment performed at home
干预措施: Transcutaneous Nerve Stimulation (TENS) (Device)
Usual Care
Usual care (no additional treatment)
结局指标
主要结局
Change from Baseline Pain Intensity at 7 weeks
时间窗: Week 0 and Week 7
Responses to questions on the Brief Pain Inventory Pain Intensity subscale used to generate pain intensity score. Minimum score=0; maximum score=10; higher score=worse outcome.
Change from Baseline Pain Interference at 7 weeks
时间窗: Week 0 and Week 7
Responses to questions on the Brief Pain Inventory Pain Interference subscale used to generate pain interference score. Minimum score=0; maximum score=10; higher score=worse outcome.
Change in Pain Intensity From Baseline to 7 Weeks
时间窗: 7 weeks
Responses to questions on the Brief Pain Inventory Pain Intensity subscale used to generate pain intensity score. Minimum score=0; maximum score=10; higher score=worse outcome. Thus if change is a negative value, that indicates improvement. If the change is a positive value, that indicates worsening.
Change in Pain Interference From Baseline to 7 Weeks
时间窗: 7 weeks
Responses to questions on the Brief Pain Inventory Pain Interference subscale used to generate pain interference score. Minimum score=0; maximum score=10; higher score=worse outcome. Thus if change is a negative value, that indicates improvement. If the change is a positive value, that indicates worsening.
次要结局
- Change from Baseline Pain Pressure Threshold at 7 weeks(Week 0 and Week 7)
- Change from Baseline Walking Endurance at 7 weeks(Week 0 and Week 7)
- Change from Baseline Gait Characteristics at 7 weeks(Week 0 and Week 7)
- Change from Baseline Physical Quality of Life (QOL) at 7 weeks(Week 0 and Week 7)
- Change from Baseline Anxiety at 7 weeks(Week 0 and Week 7)
- Change in Baseline Physical Performance at 7 weeks(Week 0 and Week 7)
- Change from Baseline Whole Body Strength at 7 weeks(Week 0 and Week 7)
- Change from Baseline Catastrophizing Behaviors at 7 weeks(Week 0 and Week 7)
- Change from Baseline Depression at 7 weeks(Week 0 and Week 7)
- Change from Baseline Physical Activity at 7 weeks(Week 0 and Week 7)
- Change from Baseline Mental Quality of Life (QOL) at 7 weeks(Week 0 and Week 7)
- Adherence to Home-based Treatment (TENS and Mindfulness Meditation groups)(week 6)
- Change from Baseline Resilience behaviors at 7 weeks(Week 0 and Week 7)
- Satisfaction with Study Experiences(week 7)
- Change from Baseline Pain Medication Use at 7 weeks(Week 0 and Week 7)
- Change in Walking Velocity From Baseline to 7 Weeks(7 weeks)
- Change in Step Length From Baseline to 7 Weeks(7 weeks)
- Change in Stride Width From Baseline to 7 Weeks(7 weeks)
- Change in Cadence From Baseline to 7 Weeks(7 weeks)
- Change in Walking Endurance From Baseline to 7 Weeks(7 weeks)
- Change in Physical Performance (SPPB Composite Score) From Baseline to 7 Weeks(7 weeks)
- Change in Whole Body Strength From Baseline to 7 Weeks(7 weeks)
- Change in Pain Pressure Threshold at Dorsal Web Space of Foot From Baseline to 7 Weeks(7 weeks)
- Change in Pain Pressure Threshold at Proximal Tibia From Baseline to 7 Weeks(7 weeks)
- Change in Mental Quality of Life (QOL) From Baseline to 7 Weeks(7 weeks)
- Change in Physical Quality of Life (QOL) From Baseline to 7 Weeks(7 weeks)
- Change in Pain-Related Quality of Life From Baseline to 7 Weeks(7 weeks)
- Change in Anxiety From Baseline to 7 Weeks(7 weeks)
- Change in Depression From Baseline to 7 Weeks(7 weeks)
- Change in Pain Catastrophizing From Baseline to 7 Weeks(7 weeks)
- Change in Resilience From Baseline to 7 Weeks(7 weeks)
- Adherence to Home-based Treatment Over 6 Weeks(over 6 weeks)
研究者
David Kietrys
Associate Professor
Rutgers, The State University of New Jersey