Comparison of the Effectiveness of Thoracolumbar Fascia Mobilization and Ultrasound-Guided Thoracolumbar Interfascial 5% Dextrose Injection in Patients With Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Lumbar spine range of motion (ROM)
研究概览
简要总结
The aim of this study is to investigate the effects of thoracolumbar fascia mobilization and ultrasound-guided thoracolumbar interfascial 5% dextrose injection on pain, range of motion, disability, quality of life, proprioception, and fascial thickness and echogenicity in patients with nonspecific chronic low back pain.
-Primary Objective: The primary objective is to evaluate the effects of these interventions on pain, functional status and range of motion.
-Secondary Objective: The secondary objective is to assess the long-term effects on quality of life, proprioception, fascial thickness, and echogenicity.
详细描述
This study aims to compare the effectiveness of thoracolumbar fascia mobilization and ultrasound-guided thoracolumbar interfascial 5% dextrose injection in individuals with nonspecific chronic low back pain. The study will evaluate the impact of these interventions on pain intensity, lumbar range of motion, functional disability, quality of life, proprioception, and the structural characteristics of the thoracolumbar fascia.
The primary objective is to determine how these treatment approaches influence pain severity, functional status, and lumbar mobility. The secondary objective is to explore their potential long-term effects on quality of life, lumbar proprioception, and thoracolumbar fascia morphology, including fascial thickness and echogenicity.
Participants will be assigned to one of three groups. The first group will receive thoracolumbar fascia mobilization using standardized myofascial release techniques applied to the thoracolumbar fascia region. The intervention will be administered twice per week for three weeks, for a total of six treatment sessions. The procedure will be performed by the research team using standardized myofascial release techniques aimed at improving fascial mobility and reducing soft tissue restrictions.
The second group will undergo ultrasound-guided thoracolumbar interfascial injection with 5% dextrose. The procedure will be performed in the prone position using a high-resolution ultrasound device with a linear probe to identify the relevant paraspinal structures. A needle will be advanced into the interfascial plane of the posterior layer of the thoracolumbar fascia under ultrasound guidance, and 10 mL of 5% dextrose solution will be injected after confirming the absence of vascular puncture.
Participants in the third group will receive a combination of both interventions, including thoracolumbar fascia mobilization and ultrasound-guided interfascial dextrose injection, according to the protocols described above.
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
- 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 or female patients aged 18 to 65 years
- •Presence of low back pain lasting longer than 3 months
- •No adequate response to medical treatment
- •Voluntary participation in the study
排除标准
- •Age below 18 or above 65 years
- •Body mass index (BMI) greater than 30 kg/m²
- •Pregnancy or breastfeeding
- •Presence of coagulation disorders
- •History of spinal surgery
- •Presence of inflammatory or malignant diseases
- •Local infection at the spine or injection site
- •Presence of lumbar disc pathology causing radiculopathy
- •Presence of spinal stenosis, spondylolysis, or spondylolisthesis
- •Participation in physical therapy or any manual therapy within the past 6 months
- •Receiving lumbar injections within the past 6 months
- •History of allergy to injection materials
- •Refusal to participate in the study
研究组 & 干预措施
Thoracolumbar Fascia Mobilization Group
Patients in this group will receive thoracolumbar fascia mobilization. A total of six sessions of myofascial release therapy will be administered twice per week for three weeks.
干预措施: Myofascial Release (Procedure)
Combined Therapy Group
Patients in this group will receive both myofascial release therapy and ultrasound-guided thoracolumbar interfascial 5% dextrose injection as described above.
干预措施: Myofascial Release (Procedure)
Thoracolumbar Interfascial 5% Dextrose Injection Group
Patients in this group will receive ultrasound-guided thoracolumbar interfascial 5% dextrose injection.
After being informed about the procedure, the patient will be placed in the prone position on the examination table, with a small pillow placed under the abdomen to allow relaxation of the lumbar muscles.
Axial scanning will be performed using a Logiq 9 (GE Medical Systems®) ultrasound device equipped with a linear probe (7-12 MHz, "ZONARE"), and the probe will be positioned at the level of the L3 spinous process. The multifidus, longissimus, and iliocostalis muscles will be visualized.
A 21-gauge (0.80 × 38 mm) needle will then be inserted from lateral to medial into the interfascial plane of the posterior layer of the thoracolumbar fascia using an in-plane technique. After confirming negative aspiration (to rule out vascular puncture), 10 mL of 5% dextrose solution will be injected into the target area.
干预措施: 5% dextrose injection (Drug)
Combined Therapy Group
Patients in this group will receive both myofascial release therapy and ultrasound-guided thoracolumbar interfascial 5% dextrose injection as described above.
干预措施: 5% dextrose injection (Drug)
结局指标
主要结局
Lumbar spine range of motion (ROM)
时间窗: Baseline, after 1 month and 3 month changes
Lumbar spine range of motion (ROM) was assessed using a dual digital inclinometer and the Modified Schober Test. For inclinometer measurements, a Baseline® Digital Inclinometer (Fabrication Enterprises Inc., USA) was used. Participants stood with feet shoulder-width apart and knees extended. The spinous processes of T12 and S1 were palpated and marked as reference points. One inclinometer was placed on T12 and the other on S1, and both were zeroed in the neutral position. Participants performed lumbar flexion, extension, and lateral flexion slowly without knee flexion or pelvic rotation. Lumbar ROM was calculated as the difference between the angular readings at T12 and S1. Each movement was measured three times and the mean value was used for analysis. Lumbar flexion was also assessed using the Modified Schober Test.
Visual Analog Scale (VAS)
时间窗: Baseline, after 1 month and 3 month changes
Patients' back pain scores will be recorded using a VAS (Visual Analog Scale). The VAS method used to assess pain intensity is a scale from 0 (no pain) to 10 (unbearable pain), with the patient selecting the number that corresponds to their pain.
Functional Status Assessment (Oswestry Disability Index - ODI)
时间窗: Baseline, after 1 month and 3 month changes
Functional status was assessed using the Oswestry Disability Index (ODI), one of the most commonly used and validated questionnaires for evaluating disability related to low back pain. The ODI consists of 10 sections, each addressing a different aspect of daily living affected by back pain, including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and employment or homemaking. Each item is scored on a 6-point Likert scale ranging from 0 (no disability) to 5 (maximum disability). The total score is calculated by summing the responses, dividing by the maximum possible score, and multiplying by 100 to obtain a percentage of disability. Higher scores indicate greater functional limitation. Participants completed the ODI questionnaire at baseline and after the intervention to assess changes in functional status over time.
次要结局
- Thoracolumbar Fascia Thickness and Echogenicity Assessment(Baseline, after 1 month and 3 month changes)
- Lumbar Proprioception Assessment(Baseline, after 1 month and 3 month changes)
- Quality of Life Assessment(Baseline, after 1 month and 3 month changes)