Clinical trial

Exercise Interventions for Overweight Men With Chronic Low Back Pain

Opening soon · Not applicable · 1 countries · Registry ID NCT07688564

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 59 Years
SexMale
Healthy volunteersNot accepted
ConditionNon-specific Chronic Low Back Pain, Central Sensitization

Full registry criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Treatments and study arms

Motor Control Exercise

Behavioral

A supervised motor control exercise program targeting deep trunk stabilizing muscles (Motor control exercises (drawing-in, multifidus, bridging, quadruped). The program focuses on improving muscle activation, coordination, and motor control during functional tasks. Sessions will be delivered twice weekly for 12 weeks under physiotherapist supervision.

Aerobic Walking Exercise

Behavioral

A supervised moderate-intensity aerobic walking program designed to improve cardiovascular fitness and enhance endogenous pain inhibitory mechanisms. (5-min warm-up (treadmill) + 20-40 min moderate walking + 5-min cool-down + 30s stretching). Participants will perform structured walking sessions twice weekly for 12 weeks, monitored by a physiotherapist.

Muscle Strengthening Exercise

Behavioral

A supervised progressive resistance training program targeting trunk and lower limb muscles. Exercises will focus on improving muscular strength, endurance, and functional capacity. (Rectus abdominis, obliques (OI/OE), erector spinae: curl-ups, side planks, bird dog, prone extension). The program will be delivered twice weekly for 12 weeks under physiotherapist supervision.

Patient Education

Behavioral

A structured educational program covering chronic low back pain mechanisms, posture correction, physical activity guidance, and self-management strategies. (Health education lectures + 10-min discussion: pain neuroscience, posture, self-management) Education will be delivered throughout the 12-week intervention period.

Primary outcomes

Conditioned Pain Modulation (CPM)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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Physiotherapy Clinic at the College of Applied Medical Sciences, Najran University, Najran City, Saudi Arabia.🌐 Najran, Najran Region, Saudi Arabia
Mohammad AbdlRahman Jarrar, Master of SciencesContact
Dr. Adel Al shahrani, PhDContact
Mohammad AbdlRahman Jarrar, Master of SciencesPrincipal Investigator