Effects of the Nottingham Arthritis App for Arthritis Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- The Pain, Enjoyment of Life and General Activity scale (PEG)
研究概览
简要总结
The aim of this run-in design, feasibility study is to assess outcomes (including opioid-use, pain intensity, emotional function, and general physical function) for an augmented reality illusion therapy in participants with chronic hand joint pain due to arthritis.
详细描述
This is a run-in design, feasibility study that uses the enrolled participants as their own control. After consenting to join the study, for the first 30 days, participants will be on their current Standard of Care (SoC). Then, for the next 30 days, the same group of participants will use the Nottingham digital treatment daily. Pre- and Post-SoC and Treatment period measures of opioid use and pain, quality of life measures will be administered and measured. Additionally, for qualifying participants, Pre- and Post-treatment functional Magnetic Resonance Imaging (fMRI) scans will be performed to assess how Nottingham AR therapy affects neuroplastic changes in the supraspinal pain network associated with the therapy sessions.
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
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female adults ages 21-80
- •Clinical diagnosis of chronic hand pain from arthritis or as determined by study physician 3) Hand joint pain at a severity of 4 and above (on a 0 to 10 scale) daily
- •Use of prescribed opioids 5) English-speaking, literate, with stable residence 5) Able to operate a smartphone as evidenced by direct observation.
排除标准
- •Major medical illness that might confound effects of pain on function (e.g., advanced cardiac or pulmonary disease)
- •Current active alcohol or substance use disorder as evidenced from medical record
- •Currently active unstable psychiatric status in previous three months as measured by direct observation, patient self-report, or medical record
- •Moderate or severe cognitive impairment as demonstrated by medical diagnosis or clinical observation
- •fMRI exclusion only: Any factors that would prevent participation in fMRI
结局指标
主要结局
The Pain, Enjoyment of Life and General Activity scale (PEG)
时间窗: Change from baseline to day 30
PEG is a three-Item scale assessing pain intensity and interference. Scale is from 0 (no pain) to 10 (pain as bad as you can imagine).
Milligrams of Morphine Equivalent (MME)
时间窗: Change from baseline to day 30
MME is a standard measure of opioid use
次要结局
- Patient Health Questionnaire (PHQ-9)(Change from baseline to day 30)
- Resting State brain imaging data(Change from baseline to day 30)
- Non-opioid pain medicine usage(Change from baseline to day 30)
- Pain Disability Index (PDI)(Change from baseline to day 30)