Observational Study of Telehealth Physical Therapy Provided for Persons With Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 4
- 主要终点
- Rate of enrolled participants initiating telehealth treatment
研究概览
简要总结
This study evaluated the feasibility of an 8-week physical therapy program for persons with chronic low back pain provided entirely using telehealth with real-time, interactive video sessions with a physical therapist.
详细描述
At the time of the onset of the COVID pandemic, the research team was conducting a clinical trial (the OPTIMIZE trial) investigating different nonpharmacologic treatments for persons with chronic low back pain (NCT03859713). One intervention arm in this trial is in-person physical therapy. COVID-related restrictions on in-person care prompted suspension of the OPTIMIZE trial. In order to accommodate persons in the midst of receiving treatment at the time of suspension, the study team adapted the in-person protocol for physical therapy for telehealth delivery using two-way, real-time video sessions. Because of the lack of research examining the feasibility of telehealth physical therapy provided in this manner, the study team decided to conduct a pilot study to examine the feasibility of the telehealth protocol.
This study was a prospective, longitudinal cohort of persons with chronic LBP seeking care in one of three healthcare systems; University of Utah Health and Intermountain Healthcare in Salt Lake City, Utah, and Johns Hopkins Medicine in Baltimore, Maryland. All participants were offered up to 8 weekly sessions of telehealth physical therapy. Outcomes included measures of acceptability, appropriateness, feasibility and fidelity as well as effectiveness measures including the Oswestry Disability Index and the PROMIS-29 health domains. Assessments occurred at baseline and after 10- and 26-weeks.
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
盲法说明
The study has only one arm
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 64 years at the time of enrollment.
- •Meets NIH Task Force definition of chronic LBP based on two questions: 1) How long has LBP has been an ongoing problem for you? and 2) How often has LBP been an ongoing problem for you over the past 6 months? A response of greater than 3 months to question 1, and "at least half the days in the past 6 months" to question 2 is required to satisfy the NIH definition of chronic LBP.
- •Healthcare visit for LBP in the past 90 days.
- •At least moderate levels of pain and disability requiring ODI score >24 and pain intensity rating > 4.
排除标准
- •Evidence of serious pathology as a cause of LBP including neoplasm, inflammatory disease (e.g., ankylosing spondylitis), vertebral osteomyelitis, etc.
- •Evidence of a specific spinal pathology as the cause of LBP including spine fracture, spinal stenosis, radiculopathy, etc.
- •Knowingly pregnant
- •Unable to participate in telehealth due to lack of technology or internet access
- •Has received physical therapy for LBP in prior 90 days
- •Currently receiving substance use disorder treatment
- •Any lumbar spine surgery in the past year.
结局指标
主要结局
Rate of enrolled participants initiating telehealth treatment
时间窗: 10-weeks
Ratio of persons attending at least 1 treatment session among all those enrolled
Change in Pain Intensity from baseline to 10 weeks
时间窗: baseline, 10 weeks
PROMIS single item (part of PROMIS-29) assessing pain intensity on 0-10 rating scale
Participant Satisfaction with Telehealth Treatment
时间窗: 10-weeks
Survey of participants evaluating treatment satisfaction
Rate of refusal to participate
时间窗: Baseline
Ratio of persons entering the study among all those eligibility for enrollment
Change in Pain Interference from baseline to 26 weeks
时间窗: baseline, 26 weeks
PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Change in Sleep Disturbance from baseline to 10 weeks
时间窗: baseline, 10 weeks
PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Change in Anxiety from baseline to 10 weeks
时间窗: baseline, 10 weeks
PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Number of sessions
时间窗: 10-weeks
Number of telehealth physical therapy sessions attended
Change in Pain Intensity from baseline to 26 weeks
时间窗: baseline, 26 weeks
PROMIS single item (part of PROMIS-29) assessing pain intensity on 0-10 rating scale
Change in Anxiety from baseline to 26 weeks
时间窗: baseline, 26 weeks
PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Change in Physical Function from baseline to 10 weeks
时间窗: baseline, 10 weeks
PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Change in Oswestry from baseline to 10-weeks
时间窗: baseline, 10 weeks
10 item measure of back pain-related disability
Change in Oswestry from baseline to 26-weeks
时间窗: baseline, 26 weeks
10 item measure of back pain-related disability
Change in Fatigue from baseline to 26 weeks
时间窗: baseline, 26 weeks
PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Change in Pain Interference from baseline to 10 weeks
时间窗: baseline, 10 weeks
PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Change in Fatigue from baseline to 10 weeks
时间窗: baseline, 10 weeks
PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Change in Social Role Participation from baseline to 26 weeks
时间窗: baseline, 26 weeks
PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Change in Sleep Disturbance from baseline to 26 weeks
时间窗: baseline, 26 weeks
PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Change in Depression from baseline to 10 weeks
时间窗: baseline, 10 weeks
PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Change in Depression from baseline to 26 weeks
时间窗: baseline, 26 weeks
PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Change in Social Role Participation from baseline to 10 weeks
时间窗: baseline, 10 weeks
PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Change in Physical Function from baseline to 26 weeks
时间窗: baseline, 26 weeks
PROMIS 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10
Change in Pain Self-Efficacy Scale from baseline to 26 weeks
时间窗: baseline, 26 weeks
10-item measure of confidence in performing activities even with pain
Change in Pain Self-Efficacy Scale from baseline to 10 weeks
时间窗: baseline, 10 weeks
10-item measure of confidence in performing activities even with pain
次要结局
未报告次要终点
研究者
Julie Fritz
Distinguished Professor
University of Utah