Comparison of Abdominal Draw-in Maneuver With Real-time Ultrasound Imaging Biofeedback vs Conservative Physical Therapy in Patients With Chronic Low Back Pain: A Prospective, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale
研究概览
简要总结
The aim of this study is to compare the effectiveness of abdominal drawing-in maneuver with real-time ultrasound biofeedback to conservative treatment in patients with chronic nonspecific low back pain.
详细描述
Low back pain is a common clinical condition among musculoskeletal disorders. It can be classified into two main categories: acute and chronic. Acute low back pain is usually limited to a duration of 6 weeks or less, whereas chronic low back pain refers to pain lasting 12 weeks or longer. Chronic low back pain is characterized by persistent and untreated pain, which can significantly affect individuals' physical and psychological health. A multidisciplinary approach is required for its treatment. Physical therapy, pharmacological approaches, psychotherapy, and exercise are the main treatment methods.
Exercise plays an active role in both the prevention and treatment of the disease. Among many exercise methods, the abdominal drawing-in maneuver has been proven effective in the literature. Biofeedback is a technique that helps individuals consciously control their physiological processes. Real-time ultrasound biofeedback stands out as a technique that directly visualizes musculoskeletal system functions. This method uses high-frequency sound waves to assess the dynamic movements of internal organs and muscle structures. Through this technology, individuals can visualize their movements in real time and consciously adjust their muscle activity or posture. It offers significant advantages, particularly in clinical and sports applications such as pelvic floor rehabilitation, postural balance training, and motor control skill development.
The aim of our study is to compare the effectiveness of exercises performed with real-time ultrasound biofeedback with those in patients receiving conservative treatment. Patients will be randomly assigned to two groups: Group 1: Patients receiving conservative treatment and performing the abdominal drawing-in maneuver with real-time ultrasound imaging biofeedback. Group 2 (Control Group): Patients receiving conservative treatment and performing the abdominal drawing-in maneuver with only verbal instruction. A total of 40 patients are planned to be included in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •The duration of low back pain is at least 3 months.
- •Low back pain with or without radiation to the lower extremities.
- •Age between 18-65 years.
- •Chronic nonspecific low back pain patients.
排除标准
- •Neuropathic pain complaints.
- •Pregnancy status.
- •History of infection, cancer, or trauma.
- •Neurological abnormalities.
- •History of lumbar spine surgery.
- •History of conservative physical therapy and/or injections in the lumbar region within the last 6 months.
- •Neurological diseases such as Parkinson's or Multiple Sclerosis.
- •Systemic diseases that prevent exercise.
- •Patients with a Mini-Mental Test score below 24.
研究组 & 干预措施
Real-Time Ultrasound Biofeedback with Abdominal Draw-In Manuever
干预措施: Conservative Physical Therapy (Other)
Real-Time Ultrasound Biofeedback with Abdominal Draw-In Manuever
干预措施: Real-Time Ultrasound Biofeedback with Abdominal Draw-In Manuever (Other)
Conservative treatment group without biofeedback
干预措施: Conservative Physical Therapy (Other)
Conservative treatment group without biofeedback
干预措施: Abdominal Draw-in Manuever (Other)
结局指标
主要结局
Visual Analogue Scale
时间窗: In the 3rd week of treatment
Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).
Muscle Thickness
时间窗: In the 3rd week of treatment
The linear probe is placed transversely at the point where the iliac crest intersects with the middle point of the T12 rib, crossing the mid-axillary line. The position of the linear probe is adjusted until all abdominal muscles are visible. To standardize the images, the center point of the probe in the image is shifted 2 cm laterally to align with the insertion of the superficial fascia of the transversus abdominis muscle. The thickness of the transversus abdominis muscle is determined by the distance between the superficial and deep fascia at the thickest point in the image. The thickness between the two fasciae is measured using the digital caliper of the device.
Visual Analogue Scale
时间窗: before treatment
Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).
Muscle Thickness
时间窗: before treatment
The linear probe is placed transversely at the point where the iliac crest intersects with the middle point of the T12 rib, crossing the mid-axillary line. The position of the linear probe is adjusted until all abdominal muscles are visible. To standardize the images, the center point of the probe in the image is shifted 2 cm laterally to align with the insertion of the superficial fascia of the transversus abdominis muscle. The thickness of the transversus abdominis muscle is determined by the distance between the superficial and deep fascia at the thickest point in the image. The thickness between the two fasciae is measured using the digital caliper of the device.
次要结局
- Berg Balance Scale(In the 3rd week of treatment)
- Oswestry Disability Index(In the 3rd week of treatment)
- Lomber Range of Motion(In the 3rd week of treatment)
- EQ-5D-3L General Quality of Life Scale(In the 3rd week of treatment)
- Berg Balance Scale(before treatment)
- Oswestry Disability Index(before treatment)
- Lomber Range of Motion(before treatment)
- EQ-5D-3L General Quality of Life Scale(before treatment)
研究者
Serdar Kilinc
Assistant Professor
Abant Izzet Baysal University