The Effects of Face-to-Face vs Online Self-Natural Posture Exercise Programs on Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Mean change from baseline muscle tone (measured by Myoton Pro device, in Hz) at week 0, 12, 24, and 36
研究概览
简要总结
Low back pain is a major health problem across the United States, with socio-economic burden, major cause of disability, and poor quality of life. One such non-pharmacologic treatment is Self-Natural Posture Exercise (SNPE), a series of exercise programs developed in conjunction with orthodontic bracing principles. Belts are worn around the hips (pelvic correction belt) and legs (right posture belt) to assist with self-directed exercise and posture correction. A typical SNPE program has eight different movements, targeting the entire axial skeleton. The exercises can be practiced anywhere and are widely applicable to patients as exercises are low- to moderate-intensity flexibility-based muscle strength training. There are several studies from Korea examining the efficacy of SNPE; however, there are few English language studies and there are no studies from outside the country of South Korea. As such, there is little data the generalizability of SNPE, the degree of cultural acceptance in other countries, and the all-important adherence to the home exercise program. The present study proposes to be the first study outside of South Korea to examine the effects of SNPE on chronic low back patients.
详细描述
The present study seeks to repeat the previously described positive clinical impact of SNPE in a new population, examine rates of adherence, and compare the effects of face-to-face versus online courses.
Specific Aims:
- Aim 1: Investigate the adherence to an SNPE program in American adults to explore the generalizability of existing Korean data.
- Aim 2: Assess the effects of a 12-week face-to-face vs online SNPE program on back pain. We hypothesize that the face-to-face group will show greater pain reduction and improvements in body posture and quality of life compared to the control group after phase 1.
- Aim 3: Compare adherence to and effects of face-to-face vs online 12-week SNPE programs.
- Aim 4: Investigate the adherence to and effects of face-to-face vs online 12-week SNPE programs at a follow-up of 12 weeks.
A single-blind randomized controlled trial (RCT) design with a wait-list control group will be used to evaluate the effect of SNPE for back pain reduction. The control group will receive online SNPE intervention after serving as an untreated comparison group. The wait-list control group serves two purposes. First, it provides an untreated comparison for the face-to-face group to determine if the intervention had an effect. By serving as a comparison group, researchers are able to isolate the independent variable and look at the impact it had. Second, it allows the wait-listed participants an opportunity to obtain the intervention at a later date.
Recruitment:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Care providers and investigators are blinded to outcome assessment. The de-identified data will be provided to the biostatistician for analysis. Analyzed data will be submitted to the PI for analysis.
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
- 是
入选标准
- •Age:18-65 yr
- •Body mass index (BMI): 18.5-34.9
- •Low back disability index: 16-50% (moderate low back pain)
- •Internet access with mobile device or desktop sufficient for video streaming
- •No plan to have back pain treatment (opioid medication, physical therapy, and/or other procedures) in the next 12 months
排除标准
- •Have had spine or pelvic orthopedic or neurologic surgery
- •Have history or evidence of functionally significant musculoskeletal deformity
- •Have history or evidence of functionally significant balance dysfunction
- •Have a significant medical (e.g., cardiac or pulmonary) condition
- •Are or plan to become pregnant
- •Not currently receiving manual or physical interventions for low back pain
结局指标
主要结局
Mean change from baseline muscle tone (measured by Myoton Pro device, in Hz) at week 0, 12, 24, and 36
时间窗: Specific metric will be gathered at outset of study and then after a 12 week intervention. It will be gathered again 12 weeks further out (24 weeks from outset). It will be gathered again 12 weeks further out (36 weeks).
Muscle tone is a biomechanical characteristic of a muscle and is measured as the muscle's natural vibration in a stable state without voluntary muscle contraction. This is expressed in frequency (㎐), and the higher the value, the higher the muscle tension. Muscle tone will be measured using a non-invasive muscle tone meter developed for objective quantification of the mechanical properties of muscles.
Mean change from baseline body alignment (measured by dartfish software, in angular degrees) at week 0, 12, 24, and 36
时间窗: Specific metric will be gathered at outset of study and then after a 12 week intervention. It will be gathered again 12 weeks further out (24 weeks from outset). It will be gathered again 12 weeks further out (36 weeks).
Posture alignment will be evaluated by photographing standing posture of study participants from the front and side and images will be analyzed using Dartfish software.
Mean change from baseline low back disability (measured by ODI) at week 0, 12, 24, and 36
时间窗: Specific metric will be gathered at outset of study and then after a 12 week intervention. It will be gathered again 12 weeks further out (24 weeks from outset). It will be gathered again 12 weeks further out (36 weeks).
Questionnaire: Oswestry Disability Index (ODI). Patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain. Questionnaire examines perceived level of disability in 10 everyday activities of daily living.
Mean change from baseline pain (measured by VAS) at week 0, 12, 24, and 36
时间窗: Specific metric will be gathered at outset of study and then after a 12 week intervention. It will be gathered again 12 weeks further out (24 weeks from outset). It will be gathered again 12 weeks further out (36 weeks).
The Visual Analog Scale (VAS). The pain VAS is a unidimensional measure of pain intensity. Patients rate their subjective pain on a scale from 0 to 10, with zero being no pain and 10 being the worst pain imaginable.
Mean change from baseline pain (measured by FPX25 device, in kg/cm^2) at week 0, 12, 24, and 36
时间窗: Specific metric will be gathered at outset of study and then after a 12 week intervention. It will be gathered again 12 weeks further out (24 weeks from outset). It will be gathered again 12 weeks further out (36 weeks).
Pain by site will be evaluated by pressure pain threshold (PPT). PPT is defined as the minimum force applied which induces pain and is an indicator of sensitivity to pain. The examiner will place a flat circular (1㎠) probe attached to the digital pressure gauge vertically on the measured muscle and pressure will be gradually applied. When the examiner releases the probe, the pressure at the time of removal appears on the screen in units of kg/cm\^2.
Mean change from baseline quality of life (measured by SF-36) at week 0, 12, 24, and 36
时间窗: Specific metric will be gathered at outset of study and then after a 12 week intervention. It will be gathered again 12 weeks further out (24 weeks from outset). It will be gathered again 12 weeks further out (36 weeks).
The 36-Item Short Form Survey (SF-36). It is a 36 question self reported measure of health and crosses 8 domains including but not limited to physical, mental, and social health.
次要结局
未报告次要终点