A Pilot Study to Analyze the Effect of Acupuncture on Mobility And Quality of Life in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Gait measured by 6-minute walk test
研究概览
简要总结
The purpose of this two-center study is to examine the effectiveness of acupuncture treatments in addressing mobility deficits, sensorimotor impairment, and quality of life (QOL) limitations in persons with Multiple Sclerosis (MS). It is hypothesized that acupuncture will result in an improvement in these limitations.
详细描述
This research study will examine the effects of acupuncture on various symptoms experienced by persons with MS. Persons with MS often use acupuncture as a way of controlling the symptoms of the disease. However, there is little research on whether or not acupuncture has any effect on MS symptoms related to movement. This study intends to look at the effects of acupuncture treatment on walking, balance, and mood in persons with MS.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of MS
- •ability to walk unaided for 6 minutes with or without assistive device
排除标准
- •bleeding precautions
- •trypanophobia
- •inability to lie still for 30 minutes
- •active cancer, current exacerbation, and history of previous acupuncture treatment
研究组 & 干预措施
Control Group
Standard of Care (SOC) treatment will be based upon Traditional Chinese Medicine (TCM) interpretation of 4 phases of MS.
干预措施: Standard of Care with no acupuncture (Procedure)
Treatment Group
60-minute treatment session twice a week for three weeks
干预措施: Acupuncture (Procedure)
结局指标
主要结局
Gait measured by 6-minute walk test
时间窗: 14 Weeks
Assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance
Balance measured by 25-foot walk test
时间窗: 14 Weeks
The T25-FW is a quantitative mobility and leg function performance test based on a timed 25-walk.
fatigue severity scale
时间窗: 14 Weeks
The Fatigue Severity Scale (FSS) is a method of evaluating the impact of fatigue. The FSS is a short questionnaire that requires patient to rate level of fatigue.
Medical Outcomes Study Pain Effects Scale
时间窗: 14 Weeks
The MOS covers pain severity in terms of intensity, frequency, and duration while recording the impact on behaviours and moods. MOS contains twelve self report items on the severity of pain over the past four weeks and its effect on mood and behaviours
次要结局
未报告次要终点