Effectiveness of Motor Control, Aerobic Walking, and Muscle Strengthening Exercises in Improving Outcomes in Overweight Male Patients With Non-Specific Chronic Low Back Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Conditioned Pain Modulation (CPM)
研究概览
简要总结
This randomized controlled trial aims to compare the effectiveness of motor control exercise, aerobic walking exercise, and muscle strengthening exercise in overweight male adults with non-specific chronic low back pain and central sensitization. A total of 156 participants will be randomly assigned to one of four groups: motor control exercise plus patient education, aerobic walking exercise plus patient education, muscle strengthening exercise plus patient education, or patient education only. The interventions will be delivered over 12 weeks.
The primary outcome is conditioned pain modulation (CPM), which reflects endogenous pain inhibitory function. Secondary outcomes include pain intensity, disability, health-related quality of life, executive function, and isometric trunk muscle strength. Body weight and body mass index will also be assessed as exploratory variables. Outcomes will be evaluated at baseline, immediately after the 12-week intervention, and at 6-month follow-up.
详细描述
Chronic non-specific low back pain (CNSLBP) is a leading cause of disability worldwide and is frequently associated with impaired pain modulation, reduced physical function, and diminished quality of life. Overweight individuals may be at increased risk of persistent low back pain due to increased mechanical loading, reduced physical fitness, and alterations in pain processing. Central sensitization has been identified as an important mechanism contributing to persistent symptoms in a subgroup of individuals with chronic low back pain.
Exercise therapy is recommended as a first-line treatment for CNSLBP; however, uncertainty remains regarding the comparative effectiveness of different exercise approaches in overweight individuals with central sensitization. Motor control exercise aims to improve the activation and coordination of deep trunk stabilizing muscles. Aerobic walking exercise may improve physical fitness and pain modulation. Muscle strengthening exercise is intended to enhance muscular strength and functional performance. Additional evidence is needed to determine which exercise strategy provides the greatest clinical benefit in this population.
This study is an assessor-blinded, four-arm, parallel-group randomized controlled trial. A total of 156 overweight male adults with non-specific chronic low back pain and evidence of central sensitization will be recruited and randomly allocated to one of four groups: motor control exercise plus patient education, aerobic walking exercise plus patient education, muscle strengthening exercise plus patient education, or patient education only. Interventions will be delivered over a 12-week period with supervised sessions conducted twice weekly.
The primary objective is to compare the effects of the interventions on conditioned pain modulation as an indicator of endogenous pain inhibitory function. Secondary objectives are to evaluate changes in pain intensity, disability, health-related quality of life, executive function, and isometric trunk muscle strength. Body weight and body mass index will also be explored as additional variables of interest.
Outcome assessments will be performed at baseline, immediately following completion of the intervention period, and at 6-month follow-up. The findings of this trial are expected to provide evidence regarding the comparative effectiveness of commonly prescribed exercise interventions for improving pain modulation and clinical outcomes in overweight men with chronic non-specific low back pain and central sensitization.
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 assessors will be blinded to group allocation. Due to the nature of the exercise interventions, participants and treating therapists cannot be blinded.
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥ 18 to < 60 years.
- •Diagnosed with nonspecific CLBP that has persisted for over three months.
- •Overweight males (not obese), with a BMI between 25.0 and 29.9 kg/m² (the standard WHO/CDC classification). Excludes normal weight (<25 kg/m²) and obesity (≥30 kg/m²) to focus on the mechanical and metabolic consequences of excess weight and to avoid confounding by significant comorbidities, mobility restrictions, or modified exercise tolerance that may skew CPM results.
- •Pain level greater than 4 on the Numerical Pain Rating Scale (NPRS).
- •Signs and symptoms indicating that a CS measurement is required must be present, with a CSI score of 40 or higher.
- •Psychological status will be screened with the Depression Anxiety Stress Scales-21 (DASS-21) to confirm the absence of clinically significant symptoms of depression, anxiety, or stress. Eligible participants will be overweight males aged 18 to 60 years with nonspecific CLBP who score within the normal range on all DASS-21 subscales. Participants with severe psychological distress will be excluded, while mild to moderate symptoms will be statistically controlled.
排除标准
- •CLBP due to a recognized specific pathology (e.g., infection, tumor, osteoporosis, fracture, structural deformity, or inflammatory disorders such as ankylosing spondylitis, radiculopathy, or cauda equina syndrome).
- •Contraindications for physical activity participation.
- •A history of spine surgery or spine diseases that cause symptoms.
- •The presence of acute pain within 48 hours prior to the study date.
- •A history of using corticosteroids or other pain-affecting medications within the past two weeks is also required.
- •Participants must not have other long-term pain conditions, high blood pressure, Raynaud's disease, frostbite, open wounds, broken bones, serious illnesses such as cancer, or mental health problems.
- •Visual and/or hearing impairments. These criteria apply uniformly to all four study arms: MCE, AW, MSE, and the patient education (control) arm.
- •These specific criteria ensure that the study group is homogeneous, which is important for examining how exercise interventions affect overweight males with nonspecific CLBP who exhibit central sensitization.
结局指标
主要结局
Conditioned Pain Modulation (CPM)
时间窗: Baseline, 12 weeks, and 6 months after intervention
Conditioned pain modulation (CPM), assessed using the Cold Pressor Test. CPM will be quantified using pressure pain threshold (PPT) measurements obtained before and after the conditioning stimulus. Higher CPM values indicate more effective endogenous pain inhibitory function.
次要结局
- Pain Intensity(Baseline, 12 weeks, and 6 months after intervention)
- Disability(Baseline, 12 weeks, and 6 months after intervention)
- Health-Related Quality of Life - Physical Domain(Baseline, 12 weeks, and 6 months after intervention)
- Health-Related Quality of Life - Psychological Domain(Baseline, 12 weeks, and 6 months after intervention)
- Health-Related Quality of Life - Social Relationships Domain(Baseline, 12 weeks, and 6 months after intervention)
- Health-Related Quality of Life - Environment Domain(Baseline, 12 weeks, and 6 months after intervention)
- Working Memory(Baseline, 12 weeks, and 6 months after intervention)
- Executive Function(Baseline, 12 weeks, and 6 months after intervention)
- Isometric Trunk Flexion Strength(Baseline, 12 weeks, and 6 months after intervention)
- Isometric Trunk Extension Strength(Baseline, 12 weeks, and 6 months after intervention)
- Isometric Trunk Lateral Flexion Strength - Right(Baseline, 12 weeks, and 6 months after intervention)
- Isometric Trunk Lateral Flexion Strength - Left(Baseline, 12 weeks, and 6 months after intervention)
- Isometric Trunk Rotation Strength - Right(Baseline, 12 weeks, and 6 months after intervention)
- Isometric Trunk Rotation Strength - Left(Baseline, 12 weeks, and 6 months after intervention)
- Body Weight(Baseline, 12 weeks, and 6 months after intervention)
研究者
Mohammad Abdel Rahman Mohammad Jarrar
PhD Candidate and Principal Investigator
Universiti Sains Malaysia