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临床试验/NCT01406847
NCT01406847已完成不适用

Central Mechanisms of Body Based Intervention for Musculoskeletal Low Back Pain

University of Florida2 个研究点 分布在 1 个国家目标入组 159 人开始时间: 2012年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
159
试验地点
2
主要终点
Change in temporal sensory summation

研究概览

简要总结

Body-based interventions have consistently shown clinical effectiveness in patients with back pain. The primary objective for this study is to compare the effect of body-based interventions commonly used in the management of low back pain on behavioral and cortical measures of pain sensitivity and central sensitization of pain. Participants will be randomly assigned to receive one of the interventions or be in a control group. The central hypothesis for this proposal is that spinal manipulation, a specific form of body-based intervention, inhibits central sensitization of pain normalizing pain sensitivity more rapidly than other interventions. The completion of the proposed study will elucidate underpinning mechanisms of body-based interventions. Identification of these mechanisms will improve the clinical application and utilization of these interventions in the management of musculoskeletal pain conditions, especially back pain.

详细描述

170 participants will be randomly assigned to receive one of the interventions or be in a control group. The investigators will use of a model of experimentally induced low back pain to investigate the effects of manipulative and body-based interventions in acute onset low back pain without some of the clinical confounds. The investigators will collect fMRI and psychophysical data about pain sensitivity before and after the induction of pain, and before and after interventions for that pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • aged 18 to 40 years
  • able to read and understand spoken English

排除标准

  • Previous participation in a conditioning program specific to trunk extensors in the past 6 months
  • Any report of back or leg pain in the past 3 months
  • Any chronic medical conditions that may affect pain perception (e.g., diabetes, high blood pressure, fibromyalgia, headaches), kidney dysfunction, muscle damage, or major psychiatric disorder
  • History of previous injury including surgery to the lumbar spine, renal malfunction, cardiac condition, high blood pressure, osteoporosis, or liver dysfunction
  • Consumption of any drugs (e.g., caffeine, alcohol, theophyline, tranquilizers, antidepressants) that may affect pain perception or hydration status from 24 hr. before participation until completion of the investigation
  • Performance of any intervention for symptoms induced by exercise and before the termination of their participation or the protocol
  • Recent illness
  • Any contraindication to MRI e.g.: pacemakers, metal implants which are not MRI compatible (e.g. aneurysm clip), pregnancy and severe claustrophobia.

研究组 & 干预措施

Spinal Manipulation

Experimental

High-velocity manual technique applied to the pelvis with the participant in supine

干预措施: Spinal Manipulation (Other)

Static Touch

Sham Comparator

Practitioner hands are placed on the lumbar spine with the participant in prone.

干预措施: Static Touch (Other)

Spinal Mobilization

Active Comparator

Oscillation of the third lumbar level performed with the participant in prone

干预措施: Spinal Mobilization (Other)

结局指标

主要结局

Change in temporal sensory summation

时间窗: 48 hours post-intervention

The change temporal sensory summation (determined using quantitative sensory testing and fMRI) will be calculated from pre-intervention to 48 hours post-intervention

Immediate change in temporal sensory summation

时间窗: 10 minutes post-intervention

We will use both behavioral (ratings) and cortical (using fMRI) measures of temporal sensory summation.

次要结局

  • Change in Physical Impairment Index(48 hours post-intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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