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临床试验/NCT03078114
NCT03078114已完成不适用

Central Mechanism of Manual Therapy for Low Back Pain

University of Kansas Medical Center2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2012年5月1日最近更新:
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
29
试验地点
2
主要终点
Change in Pain Threshold measured using Pain Pressure Threshold (PPT) testing

研究概览

简要总结

The purpose of this study is to examine the change of nervous system activity before and after spinal manipulation treatment program in people with low back pain.

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of subacute low back pain
  • Ability to read and understand English

排除标准

  • Previous low back surgery
  • Severe structural spinal deformity
  • Neurological compromise resulting in current nerve root entrapment
  • Spinal cord compression
  • Severe spinal instability
  • Severe osteoporosis
  • Psychiatric disease
  • Head trauma
  • Spinal infection
  • Known cardiovascular or metabolic disease
  • Known neurological, neuromuscular or orthopedic problems that might prevent them from participating in manual therapy interventions
  • Pregnancy
  • Mini-Mental State Examination score < 25
  • Body Mass Index (BMI) < 18 or > 30
  • Pain or paresthesia below the knees
  • Systemic illness known to affect sensation i.e. diabetes
  • Acute and/or chronic pain condition unrelated to LBP

研究组 & 干预措施

Spinal Manipulation

Experimental

Subjects with subacute low back pain. Subjects will receive 6 treatments of Spinal Manipulation (SM) over 2 consecutive weeks

干预措施: Spinal Manipulation (Other)

Placebo Spinal Manipulation

Placebo Comparator

Subjects with subacute low back pain. Subjects will be asked to visit the clinic for 6 times. The clinician will go through SM motions but the spine will not actually be manipulated.

干预措施: Placebo Spinal Manipulation (Other)

结局指标

主要结局

Change in Pain Threshold measured using Pain Pressure Threshold (PPT) testing

时间窗: Change from Pre-treatment to Post-treatment, 2 Weeks

Outcome will be measured using Pain Pressure Threshold (PPT) testing. Pressure will be applied to subjects using a digital algometer. Three trials for PPT will be done and the mean value will be calculated.

次要结局

  • Change in function measured using the Oswestry Disability Index (ODI)(Change from Baseline to Week 2)
  • Change in Low Back Pain measured using the Numerical Pain Rating Scale (NPRS)(Change from Baseline to Week 2)
  • Change in Fear Avoidance Beliefs Questionnaire (FABQ)(Change from Baseline to Week 2)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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