Duration of Spinal Manipulation Effects as Influenced by Orthotics
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Quadruple Visual Analog Pain Scale
研究概览
简要总结
Purpose of study: To assess the effects of wearing custom orthotics as opposed to placebo foot inserts on the duration of chiropractic correction of spinal fixations and muscle imbalances using applied kinesiology techniques.
详细描述
Participants with chronic lower back pain of greater than one month duration will be randomized to receive custom foot orthotics or placebo flat inserts. Both groups will receive chiropractic treatment 5 times over the course of 4 weeks following receipt of orthotics. Subjects and treating doctor will be blind to the insert type. Patients will report present, average, best and worst pain at each visit, and complete a Roland-Morris questionnaire. Secondary outcome measures will be number of fixated vertebral levels identified by motion palpation and challenge and number of muscles testing grade 4 and below from a list of 5 muscles to be tested bilaterally before and after each treatment.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current low back pain episode present for one month or more
- •No change in the past month in prescription medications affecting musculoskeletal pain
- •Able to speak and understand English adequately to complete study forms
- •Score on Roland-Morris questionnaire of 7.5 or higher or
- •Average score on Chiropractic pain Index (Now, Average, and Worst scales from the Quadruple VAS pain scale) of 4 or higher.
排除标准
- •Use of foot orthotics within the past 12 months
- •Previous lumbar spine surgery
- •Ongoing treatment for lower back pain by other health care providers other than stable prescription medications affecting musculoskeletal pain.
- •Clinically significant chronic inflammatory spinal arthritis
- •Severe osteoporosis for which spinal manipulation is contraindicated
- •Spinal pathology or fracture
- •Progressive neurologic deficits due to nerve root or spinal cord compression, including symptoms/signs of cauda equina syndrome
- •History of bleeding disorder
- •Known arterial aneurysm
- •Pending/current litigation pertaining to back pain, including workers compensation claims
- •Current pregnancy
- •Lack of means of contacting which might preclude successful completion of study requirements
- •Does not speak , read or understand English to an extent which would affect the subject's capacity to participate in informed consent
研究组 & 干预措施
Intervention, Custom Orthotics
Wearing custom foot orthotics
干预措施: foot orthotics (Device)
Sham Foot Orthotic
Wearing sham or flat shoe insoles
干预措施: Sham foot orthotic (Device)
结局指标
主要结局
Quadruple Visual Analog Pain Scale
时间窗: Six weeks
Pain present, best worst and average on a scale of 0 to 10, with 10 being the worst imaginable.
Roland-Morris Questionnaire
时间窗: Six weeks
Questionnaire listing activities of daily living, impacted by low back pain.
次要结局
- Number of fixated vertebral levels(Six weeks)
- Number of tested muscles grade 4 and below(Six weeks)