Effects of Combined High-intensity Laser Therapy and Mulligan Mobilization on Patients With Chronic Nonspecific Low Back Pain: A Pilot 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
- 50
- 试验地点
- 1
- 主要终点
- Numeric Pain Rating Scale (NPRS)
研究概览
简要总结
The goal of this clinical trial is to evaluate whether combining high-intensity laser therapy with Mulligan mobilization techniques can effectively treat chronic non-specific low back pain in adult patients aged 18-60 years, including both males and females.
The main questions it aims to answer are:
Does the combined intervention reduce pain intensity more effectively than standard or single-modality treatment? Does the combined intervention improve functional disability and lumbar range of motion?
Researchers will compare high-intensity laser therapy combined with Mulligan mobilization to [control group: Mulligan alone] to determine whether the combined approach produces superior clinical outcomes.
Participants will:
Receive high-intensity laser therapy according to a standardized treatment protocol Undergo Mulligan mobilization techniques administered by a trained therapist Attend multiple treatment sessions over a defined intervention period Complete assessments of pain intensity, functional disability, and lumbar range of motion before and after treatment
详细描述
Chronic non-specific low back pain is a prevalent musculoskeletal condition associated with pain, reduced functional capacity, and decreased quality of life. Conservative management often includes manual therapy and physical modalities; however, the optimal combination of these approaches remains unclear.
High-intensity laser therapy (HILT) has been proposed to provide analgesic and anti-inflammatory effects and to promote tissue healing. Mulligan mobilization techniques, particularly sustained natural apophyseal glides (SNAGs), are commonly used to restore pain-free movement and improve spinal function. While both interventions have shown individual benefits, evidence regarding their combined effect is limited.
This pilot randomized controlled trial aims to explore the feasibility and preliminary clinical effectiveness of combining HILT with Mulligan mobilization in adults with chronic non-specific low back pain. The study will evaluate changes in pain intensity, functional disability, and lumbar range of motion following the intervention period.
Participants will be randomly allocated to intervention groups, and outcomes will be assessed at baseline and post-intervention using standardized clinical measures. Findings from this pilot study will help inform the design of larger trials and clarify whether a multimodal approach incorporating HILT and Mulligan techniques offers added clinical value in this population.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female participants aged 18-60 years
- •Diagnosis of chronic non-specific low back pain (pain persisting for ≥3 months)
- •Pain localized between the lower costal margins and gluteal folds, with or without referred pain
- •Baseline pain intensity of ≥3 on the Numeric Pain Rating Scale (NPRS)
- •Ability to understand and follow instructions and provide informed consent
- •Not currently receiving other forms of physiotherapy or structured treatment for low back pain during the study period
排除标准
- •Specific spinal pathology (e.g., fracture, tumor, infection, inflammatory diseases such as ankylosing spondylitis)
- •History of spinal surgery
- •Neurological deficits or signs of nerve root compression (e.g., severe radiculopathy)
- •Pregnancy
- •Severe osteoporosis or other contraindications to manual therapy
- •Contraindications to high-intensity laser therapy (e.g., malignancy in the treatment area, photosensitivity disorders)
- •Current use of medications that significantly affect pain perception (e.g., high-dose opioids)
- •Participation in another clinical trial within the last 3 months
研究组 & 干预措施
Mulligan Mobilization
Mulligan Mobilization alone
干预措施: Mulligan Mobilization (Other)
High-intensity laser therapy and Mulligan mobilization
Combined high-intensity laser therapy and Mulligan mobilization
干预措施: High-intensity laser therapy and Mulligan mobilization (Device)
结局指标
主要结局
Numeric Pain Rating Scale (NPRS)
时间窗: Change from baseline NPRS at 4-week
The Numeric Pain Rating Scale (NPRS) is a self-reported measure used to assess pain intensity. It typically consists of an 11-point scale ranging from 0 to 10, where 0 indicates "no pain" and 10 represents "the worst imaginable pain." Participants are asked to select the number that best reflects their current level of pain, or their average pain over a specified period. The NPRS is widely used in clinical and research settings due to its simplicity, reliability, and validity in measuring pain intensity in individuals with musculoskeletal conditions, including chronic low back pain. Changes in NPRS scores over time are used to evaluate the effectiveness of therapeutic interventions, with a reduction of approximately 2 points often considered clinically meaningful.
次要结局
- Oswestry Disability Index (ODI)(Change from baseline ODI at 4-week)
- Lumbar Flexion Range of Motion (ROM)(Change from baseline Lumbar Flexion Range of Motion (ROM) at 4-week)
研究者
Anas Radi Hassan Alashram
Associate Professor
Middle East University