Osteopathic Manipulation Treatment Effect on the Leg and Foot Myofascial System in Adults With Chronic Low Back Pain - Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Stiffness of Low Back and Lower Extremity Muscles Assessed by Ultrasound Shear Wave Elastography
研究概览
简要总结
This pilot study will examine whether osteopathic manipulative treatment (OMT) can improve both physical and psychological aspects of chronic low back pain by focusing on the interconnected myofascial system of the back, legs, and feet. Twenty adults with chronic low back pain will receive four OMT sessions over 5-7 weeks. Before and after treatment, the investigators will measure muscle stiffness with ultrasound, plantar pressure during walking with a pressure plate, and patient-reported outcomes on pain, disability, sleep quality, stress, anxiety, depression, pain catastrophizing, and pain self-efficacy using surveys. By linking these objective and subjective measures, the study aims to provide early evidence of how OMT may influence musculoskeletal function, daily activity, and overall well-being, helping to guide future larger studies on treatment strategies for low back pain
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male and female subjects 18-65 years old
- •presence of chronic low back > 3 months duration or pain present > 50% of the time within the previous 12 months
排除标准
- •prior surgery of the thoracic, lumbar or sacral spine, pelvis
- •diagnosis lumbar radiculopathy or pinched nerve in the neck
- •diagnosis of foot condition that alters gait
- •diagnosis of connective tissue or muscle disorders
- •diagnosis of cancer
- •previous spinal cord injury inflammatory arthritis and fibromyalgia
- •pregnancy
- •tobacco use
- •known diabetes or prediabetes
- •allergy to ultrasound gel (propylene glycol)
- •history of manual therapy treatment within the past 2 weeks
- •injection for pain within the past 1 month
- •currently taking muscle relaxers
研究组 & 干预措施
OMT Treatment Group
干预措施: Osteopathic Manipulative Treatment (Other)
结局指标
主要结局
Stiffness of Low Back and Lower Extremity Muscles Assessed by Ultrasound Shear Wave Elastography
时间窗: From baseline measures on Day 1 until the last OMT treatment, up to 6 weeks.
Stiffness in the muscles of the low back and lower extremity will be quantitatively assessed using ultrasound shear wave elastography (SWE). SWE provides a non-invasive, reliable measure of tissue stiffness by calculating the shear wave speed (in meters/second) and corresponding elasticity modulus (in kilopascals). Regions of interest will be placed within target muscles and tissues (e.g., lumbar multifidus, thoracolumbar aponeurosis, hamstrings, gastrocnemius) and standardized acquisition protocols will be used to ensure reproducibility. This method allows for objective measurement of muscle stiffness rather than relying on subjective evaluation, thereby enhancing the validity of the outcome measure.
Body sway normalized path length, area, and velocity.
时间窗: From baseline measures on Day 1 until the last OMT treatment, up to 6 weeks.
A triaxial accelerometer will be used to measure postural control. The sensor will be secured over the lower trunk and measurements will occur under six conditions: feet together eyes open, feet together eyes closed, single-leg stance on the right and left with eyes opened and eyes closed. An average of 3 trials per condition will be used for each stance with 1 minute rest between trials. Double leg stance trials will be performed for 30 seconds while single leg stance trials will be performed for 15 seconds. Normalized path length (NPL) of acceleration in the anteroposterior (AP) and mediolateral (ML) directions, and sway excursion area, and velocity will be determined.
次要结局
- Low back pain intensity and frequency.(From baseline measures on Day 1 until one week after the last OMT treatment, up to 7 weeks.)
- Functional disability.(From baseline measures on Day 1 until one week after the last OMT treatment, up to 7 weeks.)
- Plantar Pressure Changes Assessed by EMED Pedobarographic Platform(From baseline measures on Day 1 until the last OMT treatment, up to 6 weeks.)
- Pain self-efficacy score(From baseline measures on Day 1 until one week after the last OMT treatment, up to 7 weeks.)