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Non-specific Chronic Low Back PainMAMS-CLBPNCT07688564

Exercise Interventions for Overweight Men With Chronic Low Back Pain

A study testing Aerobic Walking Exercise, Muscle Strengthening Exercise and Patient Education in people with Non-specific Chronic Low Back Pain and Central Sensitization, run by Universiti Sains Malaysia at 1 site in Saudi Arabia.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 59 years, men only
What is being tested?
Aerobic Walking Exercise, Muscle Strengthening Exercise and Patient Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
156 participants
Where
1 siteSaudi Arabia
Study dates
5 Jul 2026to 5 Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 59 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mohammad AbdlRahman Jarrar, Master of Sciences contact

KSA. 00966502764110 ext. Mohammad

jarrar@studen.usm.my

Saudi Arabia1 site
  • Physiotherapy Clinic at the College of Applied Medical Sciences, Najran University, Najran City, Saudi Arabia.

    Najran, Najran Region, 61441

    Mohammad AbdlRahman Jarrar, Master of Sciences, KSA. 00966502764110, jarrar@student.usm.my

    Dr. Adel Al shahrani, PhD, KSA. 00966548226011, amsalshahrani@nu.edu.sa

Other trials in Saudi Arabia

About this study

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

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.

Read the detailed description

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.

Being tested
Motor Control Exercise, Aerobic Walking Exercise, Muscle Strengthening Exercise, Patient Education
Keywords
Chronic Low Back Pain, Non-Specific Chronic Low Back Pain, Central Sensitization, Conditioned Pain Modulation, Motor Control Exercise, Aerobic Walking, Muscle Strengthening Exercise, Exercise Therapy, Overweight, Pain Modulation, Trunk Muscle Strength, Executive Function, Physical Therapy, Physiotherapy, Rehabilitation, Randomized Controlled Trial
Medical subject headings
Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Motor Control ExerciseBehavioural

    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 ExerciseBehavioural

    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 ExerciseBehavioural

    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 EducationBehavioural

    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.

Study groups in NCT07688564
Study groupRoleWhat they receive
Motor Control Exercise Plus EducationExperimentalParticipants 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).
Receives: Behavioral: Motor Control Exercise
Aerobic Walking Exercise Plus EducationExperimentalParticipants 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).
Receives: Behavioral: Aerobic Walking Exercise
Muscle Strengthening Exercise Plus EducationExperimentalParticipants 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).
Receives: Behavioral: Muscle Strengthening Exercise
Patient Education OnlyActive comparatorParticipants 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.
Receives: Behavioral: Patient Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 12 weeks, and 6 months after intervention

Secondary outcomes (15)
  1. 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.

    Measured: Baseline, 12 weeks, and 6 months after intervention

  2. 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.

    Measured: Baseline, 12 weeks, and 6 months after intervention

  3. 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.

    Measured: Baseline, 12 weeks, and 6 months after intervention

  4. 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.

    Measured: Baseline, 12 weeks, and 6 months after intervention

  5. 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.

    Measured: Baseline, 12 weeks, and 6 months after intervention

  6. 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.

    Measured: Baseline, 12 weeks, and 6 months after intervention

  7. 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.

    Measured: Baseline, 12 weeks, and 6 months after intervention

  8. 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.

    Measured: Baseline, 12 weeks, and 6 months after intervention

  9. 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.

    Measured: Baseline, 12 weeks, and 6 months after intervention

  10. 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.

    Measured: Baseline, 12 weeks, and 6 months after intervention

  11. 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.

    Measured: Baseline, 12 weeks, and 6 months after intervention

  12. 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.

    Measured: Baseline, 12 weeks, and 6 months after intervention

  13. 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.

    Measured: Baseline, 12 weeks, and 6 months after intervention

  14. 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.

    Measured: Baseline, 12 weeks, and 6 months after intervention

  15. Body Weight

    Change in body weight measured using a calibrated digital scale and reported in kilograms (kg).

    Measured: Baseline, 12 weeks, and 6 months after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2026
  2. Study start5 Jul 2026 (estimated)
  3. Primary completion5 Nov 2026 (estimated)
  4. Study completion5 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly assigned in a 1:1:1:1 ratio to one of four parallel groups: (1) motor control exercise, (2) aerobic walking exercise, (3) muscle strengthening exercise, or (4) a patient education control group. Each intervention will be delivered for 12 weeks.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
156 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07688564
Sponsor's protocol ID
HAPO-11-N-102-02604-076-043941
Other IDs
HAPO-11-N-102-02604-076-043941
Acronym
MAMS-CLBP
Status last verified
Jun 2026
First submitted
24 Jun 2026
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Aerobic Walking Exercise, Muscle Strengthening Exercise and Patient Education in people with Non-specific Chronic Low Back Pain and Central Sensitization, run by Universiti Sains Malaysia at 1 site in Saudi Arabia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mohammad AbdlRahman Jarrar, Master of Sciences (KSA. 00966502764110 ext. Mohammad, jarrar@studen.usm.my), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Conditioned Pain Modulation (CPM) (time frame: Baseline, 12 weeks, and 6 months after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.

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