Spinal Mobilization and Manipulation for Nonspecific Low Back Pain (SMM-LBP)
Effects of Spinal Mobilization and Manipulation Added to Conventional Physiotherapy on Pain Intensity, Functional Disability, Fear-Avoidance Beliefs, and Lumbar Range of Motion in Individuals With Non-Specific Low Back Pain: A Randomized Controlled Trial
Low back pain is one of the most common musculoskeletal disorders worldwide and is a major cause of pain and disability. Manual therapy techniques such as spinal mobilization and spinal manipulation are frequently used together with conventional physiotherapy; however, their additional benefits remain unclear.
This randomized controlled trial aims to investigate whether adding spinal mobilization and spinal manipulation to conventional physiotherapy improves pain intensity, functional disability, fear-avoidance beliefs, and lumbar range of motion in individuals with non-specific low back pain. Participants will be randomly assigned to receive either conventional physiotherapy alone or conventional physiotherapy combined with spinal mobilization and manipulation. Outcome measures will be assessed before and after the six-week intervention. The findings of this study may provide evidence regarding the effectiveness of combining manual therapy with conventional physiotherapy for the management of non-specific low back pain.
研究概览
地位
详细说明
Background
Non-specific low back pain is one of the leading causes of disability worldwide and is associated with substantial physical, psychological, and socioeconomic burden. Conservative physiotherapy is recommended as the first-line treatment, and manual therapy techniques such as spinal mobilization and spinal manipulation are frequently used as adjunctive interventions. However, evidence regarding their additional effectiveness when combined with conventional physiotherapy remains limited.
Objective
The aim of this randomized controlled trial is to investigate the effects of spinal mobilization and manipulation in addition to conventional physiotherapy on pain intensity, functional disability, fear-avoidance beliefs, and lumbar range of motion in individuals with non-specific low back pain.
Methods
Thirty participants with non-specific low back pain will be randomly allocated to either a conventional physiotherapy group or a conventional physiotherapy plus spinal mobilization and manipulation group. Both groups will receive conventional physiotherapy three times per week for six consecutive weeks. The intervention group will additionally receive spinal mobilization and spinal manipulation performed by an experienced physiotherapist.
Pain intensity will be assessed using the Visual Analog Scale (VAS), functional disability using the Roland-Morris Disability Questionnaire (RMDQ), fear-avoidance beliefs using the Fear-Avoidance Beliefs Questionnaire (FABQ), and lumbar range of motion using a universal goniometer. Outcome assessments will be performed at baseline and after completion of the six-week intervention.
Expected Outcomes
It is hypothesized that adding spinal mobilization and spinal manipulation to conventional physiotherapy will result in greater improvements in pain intensity, functional disability, fear-avoidance beliefs, and lumbar range of motion compared with conventional physiotherapy alone.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Ali Yıldırım, PhD
- 电话号码：+905399306460
- 邮箱：devri-alem-61@hotmail.com
学习地点
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Istanbul、土耳其（türkiye）、34744
- Ozel Mediworld
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Adults aged 18 to 60 years.
- Diagnosis of non-specific low back pain.
- Symptoms persisting for more than 12 weeks.
- Able to understand the study procedures and provide written informed consent.
- Willing to participate in the study and comply with the intervention protocol
Exclusion Criteria:
- Structural spinal abnormalities.
- Spinal infection or tumor.
- Inflammatory spinal diseases.
- Neurological disorders or neurological deficits.
- Psychiatric disorders.
- Pregnancy.
- History of recent spinal surgery.
- Chronic or systemic diseases that could affect participation.
- Conditions that could interfere with adherence to the treatment protocol
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：Conventional Physiotherapy Group
Participants received conventional physiotherapy consisting of superficial heat application using a hot pack (20 minutes), transcutaneous electrical nerve stimulation (TENS) (20 minutes), therapeutic ultrasound (5 minutes), and supervised therapeutic exercises (20 minutes), administered three times per week for six consecutive weeks.
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Participants received conventional physiotherapy consisting of superficial heat application using a hot pack (20 minutes), transcutaneous electrical nerve stimulation (TENS) (20 minutes), therapeutic ultrasound (5 minutes), and supervised therapeutic exercises (20 minutes).
The intervention was administered three times per week for six consecutive weeks, resulting in a total of 18 treatment sessions.
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实验性的：Conventional Physiotherapy + Spinal Mobilization and Manipulation Group
Participants received the same conventional physiotherapy program as the active comparator group.
In addition, spinal mobilization according to the Maitland concept and high-velocity, low-amplitude (HVLA) spinal manipulation were applied by an experienced physiotherapist three times per week for six consecutive weeks.
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Participants received conventional physiotherapy consisting of superficial heat application using a hot pack (20 minutes), transcutaneous electrical nerve stimulation (TENS) (20 minutes), therapeutic ultrasound (5 minutes), and supervised therapeutic exercises (20 minutes).
The intervention was administered three times per week for six consecutive weeks, resulting in a total of 18 treatment sessions.
Spinal mobilization and spinal manipulation were administered sequentially during the same treatment session.
Grade III central posterior-anterior oscillatory mobilization according to the Maitland concept was applied to the identified hypomobile lumbar segment, followed immediately by a high-velocity, low-amplitude (HVLA) rotational thrust manipulation performed in the side-lying position.
The intervention was individualized according to each participant's clinical presentation, symptom response, and joint mobility assessment.
All procedures were performed by the same physiotherapist with more than 10 years of clinical experience in orthopedic manual therapy, three times per week for six consecutive weeks.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Pain intensity measured using the Visual Analog Scale (VAS)
大体时间：Baseline and after 6 weeks of intervention
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Pain intensity will be assessed under three conditions (at rest, during activity, and at night) using a 10-cm Visual Analog Scale (VAS).
Scores range from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain intensity.
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Baseline and after 6 weeks of intervention
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Functional disability measured using the Roland-Morris Disability Questionnaire (RMDQ)
大体时间：Baseline and after 6 weeks of intervention
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Functional disability will be assessed using the 24-item Roland-Morris Disability Questionnaire (RMDQ).
Scores range from 0 to 24, with higher scores indicating greater disability.
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Baseline and after 6 weeks of intervention
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Fear-avoidance beliefs measured using the Fear-Avoidance Beliefs Questionnaire (FABQ)
大体时间：Baseline and after 6 weeks of intervention
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Fear-avoidance beliefs will be evaluated using the Fear-Avoidance Beliefs Questionnaire (FABQ), including physical activity and work subscales.
Higher scores indicate greater fear-avoidance beliefs.
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Baseline and after 6 weeks of intervention
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Lumbar range of motion
大体时间：Baseline and after 6 weeks of intervention
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Lumbar flexion, extension, lateral flexion, and rotation will be measured using a universal goniometer.
Three measurements will be obtained for each movement, and the mean value will be used for analysis.
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Baseline and after 6 weeks of intervention
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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