NCT00732394Unknown不适用
This is a Study is for the Purpose of Quantifying Function of the Back and Lower Extremities, and to Assess the Inter-Regional Biomechanical Relationships of the Neck, Upper Extremities, Back, and Lower Extremities in Patients Suffering From Chronic Low Back Pain.
MedAppraise, Inc.1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2008年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- To document the musculoskeletal profile of patients with low back pain
研究概览
简要总结
To administer the MSDR® (Musculoskeletal Disorder Reporting) instrument to document the musculoskeletal profile of patients with chronic low back pain, a prospective, non-randomized, multicenter treatment trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
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
- 是
入选标准
- •Must have Informed Consent Signed
- •Lumbar Disc Herniations under 5mm without Sequestered Fragments
- •Lumbar Disc Bulging
- •Lumbar Degenerative Disc Disease (mild and moderate severity)
- •Non-pregnant Females and Males suffering from Chronic Low Back Pain from 18 to 65 years of age
- •Segmental Dysfunction Secondary to Dyskinesia
- •Unresolved Nerve Entrapment Syndrome
- •Patients must be able to comply with study protocol
- •Joint Fixation Syndrome
- •Premenopausal Female Patients, excluding patients who have undergone a hysterectomy, oophorectomy, or tubal ligation, must have one of the following methods of contraception and must have a negative serum or urine b-HCG pregnancy test performed within 48 hours before initiating protocol specified treatment.
排除标准
- •Contraindications to Spinal Manipulative Therapy
- •Lumbar Canal Stenosis resulting in significant neurological comprimise
- •Any Spinal Cord Compression resulting in significant neurological comprimise
- •Cauda Equina Syndrome
- •Infection
- •Osteomyelitis
- •>65 years of age
- •History of Back or Neck Surgery
- •Acute Arthritis
- •Signs or Symptoms of Arterial Aneurysm
- •History of Active Cancer with Bone Metastasis
- •Widespread Staphyloccal and/or Strepococcal Infection
- •Acute Gout
- •Serious unstable medical illness such as cardiovascular, renal, respiratory, endocrine, gastrointestinal, or psychiatric.
- •Unstable Spondylosis, Spondylolisthesis, or Spondylolysis
- •Prior adverse experience with Spinal Manipulation Therapy
- •Uncontrolled Diabetic Neuropathy
- •Gonorreal Spinal Arthritis
- •Tuberculosis to the Bone
- •Maligancy with Metatasis to Bone
- •Excessive Spinal Osteoporosis
- •Osteomalacia
- •Ankylosis
- •Syphlitic Articular or Peri-Articular Lesions
- •Active Low Back Injury Resulting from a Motor Vehicle Accident or Work Related Injury
结局指标
主要结局
To document the musculoskeletal profile of patients with low back pain
时间窗: 1 year
次要结局
- To determine if a particular lower back diagnosis or MSDR® score can predict which patients will respond particularly well to the DRX9000™ treatment protocol and spinal manipulative therapy.(1 year)
研究者
研究点 (1)
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