An interventional study of Motor Control Exercise and Aerobic Walking Exercise in Non-specific Chronic Low Back Pain and Central Sensitization, sponsored by Universiti Sains Malaysia. Not yet recruiting at 1 site in Saudi Arabia. Open to male participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Universiti Sains Malaysia · Not applicable, Interventional, and Treatment
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.
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.
3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.
This study's planned enrollment of 156 is above the median of 73 across 3,175 interventional studies indexed under Overweight.
Browse Overweight studies →Universiti Sains Malaysia is the lead sponsor of 171 studies on the registry; 48 are open to participants now.
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Exclusion Criteria:
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.
Participants will receive a supervised motor control exercise program combined with patient education. The intervention is designed to improve activation, coordination, and control of the deep trunk stabilizing muscles. Participants will attend two supervised sessions per week for 12 weeks (24 sessions).
Behavioral: Motor Control Exercise
Participants will receive a supervised moderate-intensity aerobic walking program combined with patient education. The intervention aims to improve physical fitness and endogenous pain modulation. Participants will attend two supervised sessions per week for 12 weeks (24 sessions).
Behavioral: Aerobic Walking Exercise
Participants will receive a supervised progressive muscle strengthening exercise program combined with patient education. The program targets trunk and lower-extremity muscles to improve strength and functional performance. Participants will attend two supervised sessions per week for 12 weeks (24 sessions).
Behavioral: Muscle Strengthening Exercise
Participants will receive a standardized patient education program focusing on chronic low back pain self-management, physical activity, posture, and healthy lifestyle recommendations. Participants will attend two sessions per week for 12 weeks.
Behavioral: Patient Education
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.
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.
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.
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.
Conditioned Pain Modulation (CPM)
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.
Time frame: Baseline, 12 weeks, and 6 months after intervention
Pain Intensity
Change in pain intensity measured using the Numeric Pain Rating Scale (NPRS). Scores range from 0 to 10 points, with higher scores indicating greater pain intensity.
Time frame: Baseline, 12 weeks, and 6 months after intervention
Disability
Change in disability measured using the Oswestry Disability Index (ODI). Scores range from 0 to 100 points, with higher scores indicating greater disability related to low back pain.
Time frame: Baseline, 12 weeks, and 6 months after intervention
Health-Related Quality of Life - Physical Domain
Change in physical health-related quality of life measured using the WHOQOL-BREF Physical domain. Scores range from 0 to 100, with higher scores indicating better physical quality of life.
Time frame: Baseline, 12 weeks, and 6 months after intervention
Health-Related Quality of Life - Psychological Domain
Change in psychological health-related quality of life measured using the WHOQOL-BREF Psychological domain. Scores range from 0 to 100, with higher scores indicating better psychological quality of life.
Time frame: Baseline, 12 weeks, and 6 months after intervention
Health-Related Quality of Life - Social Relationships Domain
Change in social relationships measured using the WHOQOL-BREF Social Relationships domain. Scores range from 0 to 100, with higher scores indicating better social quality of life.
Time frame: Baseline, 12 weeks, and 6 months after intervention
Health-Related Quality of Life - Environment Domain
Change in environmental quality of life measured using the WHOQOL-BREF Environment domain. Scores range from 0 to 100, with higher scores indicating better environmental quality of life.
Time frame: Baseline, 12 weeks, and 6 months after intervention
Working Memory
Change in working memory measured using the Letter-Number Sequencing Test. The outcome will be reported as the total test score, with higher scores indicating better working memory performance.
Time frame: Baseline, 12 weeks, and 6 months after intervention
Executive Function
Change in executive function measured using the Stroop Color-Word Test. The outcome will be reported as the Stroop interference score, with higher scores indicating poorer inhibitory control and cognitive flexibility.
Time frame: Baseline, 12 weeks, and 6 months after intervention
Isometric Trunk Flexion Strength
Change in peak isometric trunk flexion strength measured using the DIERS myoline system. Higher peak force values indicate greater trunk flexion muscle strength.
Time frame: Baseline, 12 weeks, and 6 months after intervention
Isometric Trunk Extension Strength
Change in peak isometric trunk extension strength measured using the DIERS myoline system. Higher peak force values indicate greater trunk extension muscle strength.
Time frame: Baseline, 12 weeks, and 6 months after intervention
Isometric Trunk Lateral Flexion Strength - Right
Change in peak isometric right trunk lateral flexion strength measured using the DIERS myoline system. Higher peak force values indicate greater muscle strength.
Time frame: Baseline, 12 weeks, and 6 months after intervention
Isometric Trunk Lateral Flexion Strength - Left
Change in peak isometric left trunk lateral flexion strength measured using the DIERS myoline system. Higher peak force values indicate greater muscle strength.
Time frame: Baseline, 12 weeks, and 6 months after intervention
Isometric Trunk Rotation Strength - Right
Change in peak isometric right trunk rotation strength measured using the DIERS myoline system. Higher peak force values indicate greater muscle strength.
Time frame: Baseline, 12 weeks, and 6 months after intervention
Isometric Trunk Rotation Strength - Left
Change in peak isometric left trunk rotation strength measured using the DIERS myoline system. Higher peak force values indicate greater muscle strength.
Time frame: Baseline, 12 weeks, and 6 months after intervention
Body Weight
Change in body weight measured using a calibrated digital scale and reported in kilograms (kg).
Time frame: Baseline, 12 weeks, and 6 months after intervention
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Universiti Sains Malaysia