Randomized Pilot Study of Self-Administered Acupressure for Patients With Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Fatigue severity and interference in daily activities
研究概览
简要总结
The purpose of this study is to compare two kinds of self-administered acupressure (relaxation acupressure and stimulating acupressure) to usual care for management of fatigue and pain in low back pain patients.
Hypothesis: Self-administered relaxation acupressure will result in improvements in fatigue and sleep quality, pain, and physical function compared to stimulating acupressure and usual care.
详细描述
Acupressure is a Traditional Chinese Medicine (TCM) technique based on a philosophy similar to that of acupuncture. It involves the application of physical pressure on different acupuncture points (acupoints). One advantage of acupressure is the ability to self-administer the treatment. Acupressure is also a viable alternative to acupuncture in situations where patients: (1) cannot come to the clinic to receive an acupuncture treatment; (2) when a more frequent intervention is needed; or (3) where needle phobia or safety concerns are an issue.
The objective of this study is to evaluate the validity and feasibility of teaching acupressure interventions using an acupressure educator for the management of symptoms related to low back pain.
Specific aims:
- To examine the effect of 6-weeks of relaxation acupressure (RA) compared to a regime of stimulating acupressure (SA) or wait-list control (WL) on fatigue and sleep quality as assessed by Brief Fatigue Inventory and wrist-worn accelerometry (sleep efficiency).
- To explore the effect of 6-weeks of RA compared to a regime of SA or WL on for chronic low back pain in terms of reduced pain and improved function.
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 (Investigator)
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
- •Aged18-65 years
- •Non-specific low back pain (either by self-report or via ICD-9 codes 724.2, 724.5, 846.0-846.9)
- •Low back pain that has persisted for at least 3 months
- •Minimum of 3/10 on the Pain Bothersome Scale
- •Minimum of 3/10 fatigue severity
- •Ambulatory with or without assistive device
- •Ability to operate the accelerometer (Actiwatch-S)
- •Stable medication regiment for the previous 2 months
- •Report of a physician's visit during the previous 24 months
- •English-speaking
排除标准
- •Medically unstable (acute conditions or acute presentations of chronic conditions)
- •Current pregnancy
- •Radiculopathy or report of low back pain radiating to below the knee
- •Reported history of spinal fracture, herniated lumbar disc, ankylosing spondylitis, and spinal stenosis.
- •Report of back surgery within the preceding 12 months
- •Participation in active litigation or compensation claims
- •Conditions that might confound treatment effects or interpretation of results (for example, rheumatoid arthritis, lupus)
- •Acupuncture or acupressure within the preceding 12 months
- •Report of sleep apnea
- •2nd or 3rd shift workers or other non-traditional sleep schedules
- •Use of anti-coagulant/platelet therapy within the preceding month
结局指标
主要结局
Fatigue severity and interference in daily activities
时间窗: Week 0 (baseline) and approximately 9 weeks (follow-up)
Fatigue severity and interference in daily activities will be measured using the Brief Fatigue Inventory. Subjects will answer the BFI at both baseline and follow-up. To investigate a change from baseline in fatigue, the difference between the post-assessment outcomes and baseline measures will be calculated. Analyses on these differences will be performed using independent samples t-tests between treatment groups. We will also evaluate all continuous outcomes by ANCOVA, adjusting for baseline value and treatment group.
Sleep quality via objectively measured sleep efficiency
时间窗: Week 0 (baseline) and approximately 9 weeks (follow-up)
We will use wrist-worn accelerometry to assess sleep efficiency. Subjects will wear a wrist-worn accelerometer for 7 consecutive days (at baseline and follow-up) that collects in vivo sleep quality data; an accompanying logbook will be used to enhance objective data. To investigate a change from baseline in sleep efficiency, the difference between the post-assessment outcomes and baseline measures will be calculated. Analyses on these differences will be performed using independent samples t-tests between treatment groups. We will also evaluate all continuous outcomes by ANCOVA, adjusting for baseline value and treatment group.
次要结局
- Level of physical functioning as measured by the Roland-Morris Disability Questionnaire.(Week 0 (baseline) and approximately 9 weeks (follow-up))
- Pain severity and interference in daily activities(Week 0 (baseline) and approximately 9 weeks (follow-up))
研究者
Susan Murphy
Associate Professor, Department of Physical Medicine and Rehabilitation
University of Michigan