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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pain intensity measured using the Visual Analog Scale (VAS)
研究概览
简要总结
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.
详细描述
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
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)
盲法说明
Outcome assessments were performed by an independent assessor who was blinded to group allocation. Due to the nature of the interventions, participants, care providers, and investigators were not blinded.
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
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Conventional Physiotherapy (Other)
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.
干预措施: Spinal Mobilization and Manipulation (Other)
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.
干预措施: Conventional Physiotherapy (Other)
结局指标
主要结局
Pain intensity measured using the Visual Analog Scale (VAS)
时间窗: Baseline and after 6 weeks of intervention
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.
次要结局
- Functional disability measured using the Roland-Morris Disability Questionnaire (RMDQ)(Baseline and after 6 weeks of intervention)
- Fear-avoidance beliefs measured using the Fear-Avoidance Beliefs Questionnaire (FABQ)(Baseline and after 6 weeks of intervention)
- Lumbar range of motion(Baseline and after 6 weeks of intervention)
研究者
alyildirim
Principal Investigator
Biruni University