The Short-Term Effects of Manipulation and Physical Therapy on Physical Activity Levels
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 主要终点
- Change in Physical Activity Levels
研究概览
简要总结
The primary purpose is to examine the impact that physical therapy (PT) interventions, including manipulations, have on physical activity levels outside of the clinical environment in persons with low back pain (LBP) as measured both objectively with an accelerometer and subjectively with questionnaires.
The secondary purpose is to determine if a relationship exists between objective physical activity, self-perceived disability pain catastrophizing thoughts, BMI, age, six-minute walk distance, lower extremity muscle endurance.
The tertiary purpose is to assess the predictive value that a standing manual lumbar unloading technique has for relief of pain following manipulation
详细描述
At session 1: Participants are screened for eligibility. Baseline outcome measures are conducted (self-report questionnaires and physical performance tests). Accelerometer which is an instrument to measure physical activity is issued.
At session 2 (To occur at least one-week later): Accelerometer data is retrieved and downloaded to a computer. Participant numerically rates low back pain level at rest and in most painful position. Participant receives a manual distraction procedure. Participant rates pain level again. Participant starts the physical therapy intervention (manipulation of the spine, muscular strengthening and cardiovascular exercise, education). Accelerometer is reissued again.
At session 3 (At least one-week later): Accelerometer is collected and data is retrieved. Participant continues with the intervention (manipulation, exercise, education).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient referred to outpatient PT with a LBP related diagnosis
- •LBP without radiating pain distally to the knee > 3 months in duration
- •Ability to read and write in English or Spanish
- •Age between 18 and 70 years
- •Able to ambulate independently without assistive devices
- •Access to a computer or cell phone with an email address and/or the ability to receive short text messages
排除标准
- •No previous diagnosis, radiological evidence, or clinical signs and symptoms of instability, spondylolysis, spondylolisthesis, fracture, tumor or metastases to the spine
- •No clinical indication of nerve root pathology such as: straight leg raise less than 45 degrees, asymmetric lower extremity deep tendon reflexes, lower extremity muscle strength deficits or radiating pain, numbness or tingling below the knee
- •No surgical or biological fusion to the spine
- •No previous spinal surgery
- •No known diagnosis of osteoporosis or rheumatoid arthritis
- •No use of oral steroids within the past 6 months
- •No epidural injection over the previous 4-weeks to the lumbar spine region
- •No current litigation, workman's compensation or disability claim for a low back injury
- •No known pregnancy
结局指标
主要结局
Change in Physical Activity Levels
时间窗: 2 weeks
Accelerometer issued to subject at the initial data collection session and then data collected and downloaded one week later. Subject receives the intervention session, then is reissued the accelerometer. Subject returns the accelerometer one week after this intervention session with data that reflects physical activity levels that are after the intervention session
次要结局
未报告次要终点
研究者
Wayne Brewer
Assistant Professor
Texas Woman's University