NCT01842737已完成不适用
PRoGReSS-PS: Patient Response to GRraded Sensory Stimulation: A Pilot Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Back Pain Visual Analogue Scale
研究概览
简要总结
The Patient Response to Graded Sensory Stimulation-Pilot Study (PRoGReSS-PS) will measure back pain perceptions in participants who receive either chiropractic treatment or foot massage. The study will also measure back pain and function with research questionnaires and other measures.
详细描述
The Patient Response to Graded Sensory Stimulation Pilot Study (PRoGReSS-PS) will measure back pain perceptions in participants who receive either chiropractic treatment or foot massage. In this study, the researchers will:
- Measure the participant's back pain and function using research forms.
- Test the participant's ability to discern different touch sensations in the low back.
- Assess the participant's perceptions of the study procedures on research forms during the study and in a short interview at the end of the study.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21-65 Years
- •Low Back Pain (LBP) meeting Quebec Task Force (QTF) Classifications 1-6
- •Minimum LBP pain level on the 11-point NRS (Worst pain past 24 hours)
- •LBP classified as chronic (onset more than 12 weeks previous)
- •Written Informed Consent
- •No plans to move out of the area in the next 6-8 weeks
- •Transportation to come to the clinic on a regular basis
排除标准
- •LBP meeting QTF Classifications 7-11
- •Bone and joint pathology contraindicating spinal manipulation including: joint instability; recent spinal or rib fracture, or non-union; severe osteoporosis; spinal or paraspinal tumors; aortic aneurysm > 5 cm; cauda equina syndrome
- •Retention of legal advice related to this or a previous LBP episode or participants with active occupational or personal injuries cases
- •Inability to read or verbally comprehend English
- •Legally blind even with the aid of glasses and/or contact lenses
- •Evidence of alcohol or drug dependence or abuse per self-report or as determined by history and examination
- •Depression scores > 29 (severe) on the Beck Depression Inventory-II
- •Unwillingness to postpone use of all other types of manual treatment for LBP except those provided in the study for the duration of the study period
- •Co-morbidity requiring coincident clinical management, or prevent delivery of care, or interfering with ability to assess participant health status and/or treatment outcomes
- •Co-morbidity requiring referral for serious or potentially serious health concerns
- •Inflammatory disease of the spine (e.g. Ankylosing spondylitis, Rheumatoid arthritis)
- •Uncontrolled hypertension
- •Unable to safely tolerate study procedures
- •Need for additional diagnostic procedures other than x-ray or urinalysis
- •Pregnancy or seeking to become pregnant during active study phase
- •Seeking or receiving compensation for any disability
- •Unable or unwilling to comply with study protocol
- •Extremity conditions preventing safe massage (e.g., injuries, infections)
- •Minimum pain level at each eligibility appointment
- •Recent tattoos or piercing in lumbar region (within past 6 months)
- •Peripheral neuropathy in the extremities due to safety concerns
- •Amputation of any extremity
- •Bleeding disorders due to safety concerns
- •Currently taking any opioid medication due to impact on pain perception
- •Unable to identify at least 3 out of 5 letters drawn on dominant hand during baseline examination due to somatosensory outcome measure (graphesthesia)
- •Fracture in back, hips or ribs past 8 weeks
- •History of spinal surgery or spinal injections to low back
结局指标
主要结局
Back Pain Visual Analogue Scale
时间窗: 4 Weeks
The Back Pain Visual Analogue Scale (VAS) has excellent metric properties, is easy to administer and score, and is commonly used in LBP research. Our anchors will be no pain to worst pain imaginable and use the average of 3 VAS questions: worst LBP in the last 24 hours; least LBP in the last 24 hours; and average LBP in the last 24 hours.
次要结局
- Two-Point Discrimination(4 Weeks)
- Roland Morris Disability Questionnaire(4 Weeks)
- Graphesthesia(4 Weeks)
- Line Drawing(4 Weeks)
研究者
Christine M. Goertz
Vice Chancellor for Research and Health Polciy
Palmer College of Chiropractic
研究点 (2)
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