Microcurrent Treatment for Chronic Debilitating Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Measure Yourself Medical Outcome Profile (MYMOP)
研究概览
简要总结
To compare the efficacy of standard pain treatment and placebo (a microcurrent faux treatment) as opposed to standard pain treatment and microcurrent therapy in any primary care patients over a three month period.
详细描述
This study is not intended to be definitive and should be considered an exploratory randomized trial to determine conditions for which microcurrent is more effective. Thus, extensive subgroup analyses will be performed so that definitive trials can be developed. This is a single-blind study where subjects will not know if they are receiving microcurrent treatment.
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
- •**Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study**
- •Inclusion Criteria:
- •Male and female Active Duty members and DoD beneficiaries
- •Age 18 years or older
- •Chronic debilitating pain
- •PROMIS-57 T score is 60 or above
排除标准
- •Implanted pacemaker
- •Spinal cord stimulator
- •Illicit drug use including marijuana use
- •Epilepsy or a history of seizures
- •Other implanted device (e.g., insulin pump, opioid pump, or defibrillator)
- •Chronic debilitating pain referred or recruited as measured by PROMIS-57 T score is below 60
结局指标
主要结局
Measure Yourself Medical Outcome Profile (MYMOP)
时间窗: POST-TREATMENT: time 6 (week 12)
MYMOP measures the outcomes that the patient considers the most important.On follow-up questionnaires the wording of the previously chosen items is unchanged. Produces a 7-point scale (0=as good as it could be, 6=as bad as it could be) for individual items of Symptoms, Activity, and Wellbeing as well as the MYMOP profile score
Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores
时间窗: SCREENING
PROMIS-57 is a collection of 8-item short forms assessing anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, and ability to participate in social roles and activities as well as a single pain intensity item.
Defense and Veterans Pain Rating Scale (DVPRS)
时间窗: POST-TREATMENT: time 6 (week 6)
The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VHA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used.
次要结局
- Opioids taken(screening, time 0 (week 0), time 1 (week 1), time 2 (week 2), time 3 (week 3), time 4 (week 4), time 5 (week 5), time 6 (week 12))
研究者
Paul Crawford
Principal Investigator
Mike O'Callaghan Military Hospital