A Randomized Comparative Effectiveness Trial of Two Postural Therapies for People With Chronic Lower Back Pain (cLBP)-Gokhale Project
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- PROMIS-29 questionnaire
研究概览
简要总结
The study aims to compare the effectiveness of the Gokhale Method posture therapy for low back pain (LBP) management to standard physical therapy (PT) with posture training. The second aim of this study is to evaluate usability and user adherence of the online/digital intervention through the Gokhale Method Foundation Class (online delivery with smartphone App).
The investigator hopes to learn:
The effectiveness of the Gokhale Method posture therapy for low back pain management, in comparison to the effectiveness of standard physical therapy with posture training.
the usability and user adherence of the online/digital intervention through the Gokhale Method Foundation Class (online delivery with smartphone App).
详细描述
100 participants with chronic low back pain will be recruited through the Stanford PMR clinics (Redwood City, Emeryville, Los Gatos, and Palo Alto). Information about the study will also be disseminated to the Stanford Primary Care clinics and through community advertisements.
Patients will be referred to the reaserch team by the providers who is been recommended for Physical Therapy.
Research team personnel will approach the recommended patients via email and will screen them prior to consenting for eligibility criteria by sending out a set of questionnaires via Redcap.
Eligible patients will be consented remotely via Redcap and will be subjected to randomization.
Eligible and consented participants will be randomly assigned (1:1) into one of the two intervention groups. Prior to intervention, participants will be asked to complete questionnaires on demographics, self-reported levels of pain, functional status, and disability levels. The questionnaires include:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- 否
入选标准
- •18-65 years old (working age population).
- •NPRS score 4 or more for lower back.
- •RMDQ score 7 and above.
- •English speaking population
- •Need insurance
排除标准
- •Pregnancy (as stated by patient)
- •With cognitive or communication impairment .
- •Patients recommended for surgery
- •Participating in other form of intervention.
- •Prior history of chronic neurological disorder that impacts mobility (e.g. stroke, Parkinson's disease, multiple sclerosis)
- •Fibromyalgia
- •Underwent PT treatment for low back pain in the last 6 months
- •Underlying mental disorder/untreated depression or presence of neurologic disorders such as MS, Alzheimers, Parkinsons
研究组 & 干预措施
Gokhale ARM
Participants enrolled in the Gokhale Arm will be provided the Gokhale PostureTracker, a wearable posture monitoring sensor developed for interactive posture coaching, and a loaner smartphone with pre-installed App. Participants will be provided instruction to apply the sensor on their lumbar area and receive real-time visual feedback on their posture kinematic during the class. Participants can also perform normal daily activities while wearing the device. Data collected by the sensor will be sent to a HIPAA compliance server and shared with Stanford researchers.
干预措施: Gokhale sensor (Device)
Physical Therapy ARM
Participants randomized into the standard care/physical therapy (PT) arm will similarly receive a standardized PT prescription during a 6-12 weeks period, meeting 1-2 times per week, to include posture education and training, therapeutic exercise instructions and development of an independent home exercise program.
结局指标
主要结局
PROMIS-29 questionnaire
时间窗: 6-12 weeks
Patient-Reported Outcomes Measurement Information System
NPRs ( national pain score)
时间窗: 6-12 weeks
Average pain score related to lower back
RMDQ questionnaire
时间窗: 6-12 weeks
Roland Morris Disability Questionnaire
次要结局
- patient satisfaction and adherence(12 months)
- Type, incidence and severity of complications and adverse events(12 months)
- Concurrent pain medication use (including opioids)(12 months)
研究者
Matthew W Smuck
Assoc Professor
Stanford University