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Exercise Interventions for Overweight Men With Chronic Low Back Pain

Not yet recruitingNot applicableNCT07688564
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
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
Interventions
Sponsor
Universiti Sains Malaysia
Start date
2026-07-05
Primary completion
2026-11-05
Sex
Male
Age range
from 18 Years to 59 Years
Results posted
No results posted in this snapshot
Countries
Saudi Arabia
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07688564