The Effect of Physical Therapy Interventions Directed at the Low Back Versus Low Back and Hips for Individuals With a Primary Complaint of Low Back Pain: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 13
- 主要终点
- Change from baseline on the Numeric Pain Rating Scale (NPRS)
研究概览
简要总结
Low back pain (LBP) is the leading cause of disability worldwide and has substantial impacts on pain and function for an individual. Some individuals with LBP seek physical therapy for their condition. The purpose of the study is to determine whether individuals with LBP have improved pain and disability following physical therapy targeting either the low back only or low back plus hip(s).
详细描述
Often, individuals with LBP also have concurrent impairments in strength and/or range of motion of one or both hips. Physical therapists may or may not decide to treat the concurrent hip impairments for an individual with LBP based on their clinical decision making. Currently, it is unknown which approach leads to superior patient outcomes in terms of pain and disability.
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
- None
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
- •Modified Oswestry Disability Index (ODI) ≥ 20%
- •Numeric Pain Rating Scale (NPRS) of ≥ 2 points
- •Primary complaint of low back pain with at least one hip impairment in one or both hips
排除标准
- •Contraindications to manual therapy
- •Severe trauma to the lumbar spine or hip(s) in the last 6 weeks
- •'Red flag' symptoms including:
- •Metabolic disease
- •Rheumatoid arthritis or other systemic rheumatologic disorders
- •Acute fracture
- •Bowel/Bladder dysfunction
- •Prolonged history of corticosteroid use
- •Evidence of central nervous system involvement
- •Two or more positive neurologic signs consistent with nerve root compression:
- •Diminished muscle stretch reflexes of lower extremity
- •Muscle weakness in any lower extremity myotome
- •Diminished or absent sensation in any lower extremity dermatome
- •Spinal surgery in the last 6 months
- •Total Hip Arthroplasty
- •Currently pregnant or post-partum ≤ 6 months
- •Osteoporosis
- •History of cancer within the last 12 months
- •Inability to understand the English language
结局指标
主要结局
Change from baseline on the Numeric Pain Rating Scale (NPRS)
时间窗: Baseline, 2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months
The NPRS is an 11 point scale (0-10) where the participant is asked to rate their pain intensity at best, worst and average over the last 24 hours. The scale is anchored on the left (score of 0) with the phrase "No Pain" and on the right (score of 10) with the phrase "Worst Imaginable Pain". The NPRS is a valid and reliable assessment of pain severity for individuals with low back pain.
Change from baseline on the Modified Oswestry Disability Index (ODI)
时间窗: Baseline, 2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months
The ODI is a reliable and responsive 10 question condition-specific self-report measure for individuals with LBP. The ODI is scored on a scale from 0% to 100%, higher scores indicating higher levels of disability.
次要结局
- Patient Health Questionnaire-2 (PHQ-2)(Baseline)
- Change from baseline on the Fear Avoidance Beliefs Questionnaire (FABQ)(Baseline, 2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months)
- Change from baseline on the Global Rating of Change (GROC)(2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months)
- Change from baseline on the Patient Acceptable Symptom State (PASS)(2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months)
- Change from baseline on the Godin Leisure-Time Physical Activity Questionnaire(Baseline, end of intervention (discharge; an average of 6 weeks))