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临床试验/NCT03031158
NCT03031158
已完成
不适用

Pilot Trial of a Hip-spine Intervention for Older Adults With a Primary Complaint of Low Back Pain

University of Delaware1 个研究点 分布在 1 个国家目标入组 24 人2017年2月1日
适应症Low Back Pain

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Low Back Pain
发起方
University of Delaware
入组人数
24
试验地点
1
主要终点
Quebec Low Back Pain Disability Scale
状态
已完成
最后更新
7年前

概览

简要总结

Low back pain (LBP) is extremely common in older adults and is associated with a host of negative consequences, including decreased physical function and increased healthcare utilization. Among older adults with LBP, hip impairments indicative of hip joint disease are more prevalent and associated with greater disability than among older adults without LBP. This study will investigate a novel intervention designed to improve LBP-related disability by combining a typical spine-focused exercise program with a hip-focused intervention.

注册库
clinicaltrials.gov
开始日期
2017年2月1日
结束日期
2018年3月13日
最后更新
7年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Gregory Evan Hicks

Associate Professor

University of Delaware

入排标准

入选标准

  • Low Back Pain for ≥ 3 months with pain of at least moderate intensity every day or almost every day that requires activity modification.
  • Presence of at least 1 hip impairment denoted by the American College of Rheumatology as potential indicators of hip osteoarthritis: hip pain, pain on hip internal rotation or morning stiffness of the hip of \<60 minutes.

排除标准

  • Previous hip fracture repair or total hip replacement
  • Prominent component of radicular pain: CLBP with distal radiation below the knee
  • Known spinal pathology other than osteoarthritis: (e.g., a history of back surgery or recent trauma, spinal stenosis, vertebral compression fractures, ankylosing spondylitis, carcinoma metastatic to the spine)
  • Non-ambulatory, or severely impaired mobility (i.e., require the use of a wheelchair)
  • Folstein Mini-Mental State Examination score of \<24
  • Severe visual or hearing impairment.
  • Red flags indicative of a serious disorder underlying the LBP: Red flags that would require specialized medical attention include fever, significant unintentional weight loss, a sudden recent change in the character or intensity of pain, trauma that preceded the onset of pain, or signs and symptoms of caudae equinae (i.e. loss of sensation over saddle region, significant disturbances in bowel and bladder function).
  • Significant pain in parts of the body other than the back or acute LBP.
  • Acute, ongoing illness.
  • Inability to participate in the study for the full six months for any known reason.(i.e. moving away, extended vacation)

结局指标

主要结局

Quebec Low Back Pain Disability Scale

时间窗: Change in disability score from pre-intervention to 20 weeks later

Patient-Specific Functional Scale

时间窗: Change in pain-related function score from pre-intervention to 20 weeks later

次要结局

  • Walking Endurance as measured by the 6 minute walk test(Change in walking endurance from pre-intervention to 20 weeks later)
  • Walking speed(Change in walking endurance from pre-intervention to 20 weeks later)

研究点 (1)

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