An interventional study of MAILE (Multi Angular Isometric Exercise) in Nonspecific Low Back Pain, Low Back Pain and Chronic Low-back Pain (cLBP), sponsored by Hamad Medical Corporation. Recruiting at 1 site in Qatar. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Hamad Medical Corporation · Not applicable, Interventional, and Treatment
The study aims to evaluate the effectiveness of Multi Angular Isometric Lumbar Exercise (MAILE) in comparison to traditional lumbar stabilization and core stability treatments for managing nonspecific chronic low back pain (NCLBP). MAILE is designed to specifically target the Lumbo-Pelvic Hip complex with the goal of improving pain levels, stability, strength, and overall function.
Objectives of the study are to assess several key outcomes:
Pain Intensity: Measuring the level of pain experienced by patients. Functional Disability: Evaluating the impact of NCLBP on daily activities and overall function.
Functional Stability: Assessing the stability of the Lumbo-Pelvic Hip complex during movement.
Muscle Strength: Determining the strength of muscles within the targeted region.
By examining these outcomes, the research seeks to determine whether MAILE offers superior benefits and greater cost-efficiency compared to conventional treatments for patients with NCLBP and motor control dysfunction. If successful, MAILE could provide a more effective and economical approach to managing this common and debilitating condition. This Randomized Clinical Trial (RCT) will be conducted across multiple outpatient clinics within the Hamad Medical Corporation (HMC). The study will involve 98 patients diagnosed with non-specific chronic low back pain (NCLBP), who will be randomly assigned to one of two groups: the Multi Angular Isometric Lumbar Exercises (MAILE) group or the Core Stability group. Both groups will follow tailored exercise programs over a three-week period.
The MAILE group will focus on exercises designed to enhance lumbar stability and core strength through multi-angular isometric lumbar exercises performed at various angles. These exercises aim to target the deep stabilizing muscles of the lumbar spine, promoting overall spinal stability and reducing pain. The Core Stability group will engage in exercises that emphasize the activation and strengthening of the core muscles, which play a crucial role in maintaining spinal stability and function.
The outcomes of this trial will help determine the effectiveness of MAILE compared to traditional core stability exercises in managing NCLBP, potentially guiding future therapeutic strategies.
This protocol is anchored in a motor control \& stability impairment model of nonspecific chronic low back pain (NCLBP). Instead of treating LBP as a purely structural issue, it frames it as a neuromuscular coordination and load management failure within the lumbopelvic-hip complex (LPHC). MAILE isn't just strengthening - it's angle-specific neuromuscular reprogramming, which aligns with modern rehab thinking.
The protocol builds on several deeper mechanisms:
Motor Control Dysfunction - Delayed activation of transversus abdominis (TrA) and multifidus / Over-reliance on global muscles (rectus abdominis, erector spinae) / Leads to segmental instability + microtrauma cycles.
Load Transfer Failure - LPHC acts as a force transmission unit / Weakness or poor coordination and abnormal load distribution / Results in: Facet joint stress / Disc degeneration / Ligament strain.
Recurrence Mechanism - Not a one-time injury → relapsing-remitting cycle / Driven by: - Poor movement variability / Reduced adaptability under load.
This is a Randomized Controlled Trial (RCT) with solid internal validity features:
Randomization Strategy - Stratified randomization (Reduces confounding / Ensures balanced groups).
Allocation Concealment - Sealed envelope method (Prevents selection bias). Blinding Structure - Single-blinded. Realistic physiotherapy trials, Maintains outcome objectivity.
Power Calculation - Effect size = 0.6 / Power = 80% / Alpha = 0.05 / Adjusted for 10% dropout → 98 participants.
Inclusion / exclusion criteria are not generic - Inclusion is based on: Movement coordination impairment (ICF framework) Clinical instability signs: Positive prone instability test / Aberrant movement patterns / Hyper-mobility.
Exclusion : Structural pathology (fracture, tumor, radiculopathy) Red flags (cauda equina, severe osteoporosis) Confounders (surgery, systemic disease) Both groups are active - MAILE Group (Multi-angle isometric contractions) Targets: Deep stabilizers (multifidus, TrA) / Global stabilizers (QL, obliques) Focus: Static control under varying joint angles / Reduced shear forces Control Group (Traditional) - Core stability / Lumbar stabilization Outcome measure of the study - to assess Pain Visual Analogue Scale (VAS) / Functional Disability - Oswestry Disability Index (ODI) / Muscle Activation - Pressure Biofeedback Unit (PBU) / Functional Stability (Multi-level testing): Single-leg balance → static control / Single-leg squat → dynamic control / Three-plane testing → multiplanar stability.
Measurement time, Baseline → establishes reference / Midpoint (after 3 sessions) / Post (after 6 sessions) to see treatment effect. Risk Framework: Physical Risks (Muscle soreness / Fatigue / Minor strain) Non-Physical Risks (Psychological stress, Data privacy) / Special Considerations - (Pregnancy exclusion / Unpredictable risks acknowledged).
Statistical Strategy - Descriptive: (Mean, SD, median, IQR) Comparative: (Independent T-tests / Mann-Whitney U / Chi-square for categorical data, Hypothesis Testing: Two-tailed / p \< 0.05.
2,884 studies on the registry are indexed under Low Back Pain; 483 are open to participants now.
This study's planned enrollment of 98 is above the median of 60 across 2,324 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →Hamad Medical Corporation is the lead sponsor of 139 studies on the registry; 27 are open to participants now.
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Participants eligible for this study must meet the following criteria:
Age between 18-60 years Diagnosed with Nonspecific Chronic Low Back Pain (NCLBP) by an orthopedic doctor, general physician, neurologist, or primary healthcare doctor Low back pain lasting for more than 3 months (pain between T12 and the gluteal fold) Must have had more pain-free days than painful days during the past year Pain located mainly in the lower lumbar region (L4/L5 and/or L5/S1) Presence of positive prone instability test Presence of aberrant movement during motion testing Straight Leg Raise > 91° BMI between 20-30
Presence of one or more of the following:
Pain worsens with sustained end-range movements or positions Lumbar hypermobility on segmental motion assessment Mobility deficits of the thorax and lumbopelvic/hip regions Reduced trunk or pelvic muscle strength and endurance Movement coordination impairments during work, recreational, or daily functional activities
Patients must also:
Be willing and able to safely participate in an exercise program Have no cognitive impairment limiting participation
Exclusion Criteria:
Participants will be excluded if they have any of the following:
Radiculopathy (confirmed through clinical and neurological assessment) Cauda equina symptoms (e.g., bowel/bladder dysfunction, perianal numbness) Spinal deformities (fracture, infection, tumor) Severe osteoporosis History of lumbar spine surgery Pregnancy Psychiatric illness or cognitive impairment (e.g., dementia) Substance abuse
Use of medications:
Current anticoagulants or corticosteroids Long-term steroid use (≥7.5 mg for >6 months) Recent or significant trauma Pain or neurological symptoms during positioning or lever application (unsafe for intervention) Cardiac conditions Cancer
Other significant medical conditions, including:
Rheumatologic disorders Spinal infections Prior back surgery
Multi Angular Isometric Lumbar Exercise (MAILE) will produce superior outcomes compared to traditional Core Stability and Lumbar Stabilization exercises in terms of: Pain reduction, Improved functional ability, Better core stability, Increased lumbar muscle strength and greater overall treatment effectiveness
Other: MAILE (Multi Angular Isometric Exercise)
Control group participants will receive a graded exercise program consisting of lumbar stabilization and core stability exercises aimed at improving spinal stability, muscle strength, functional ability, and pain reduction in patients with nonspecific chronic low back pain.
A single-blinded, parallel-group, stratified randomized controlled clinical trial comparing Multi Angular Isometric Lumbar Exercise (MAILE) with Core Stability and Lumbar Stabilization Exercises in patients with nonspecific chronic low back pain.
Visual Analogue Scale (VAS)
Pain Intensity measured using Visual Analogue Scale (VAS)
Time frame: Baseline assessment before intervention, midpoint assessment after 2 treatment sessions, and final assessment after completion of 6 sessions over a total intervention period of 3 weeks.
Oswestry Disability Index (ODI)
Measured using the Oswestry Disability Index (ODI) to evaluate how low back pain affects daily activities and overall function.
Time frame: Baseline assessment before intervention, midpoint assessment after 2 treatment sessions, and final assessment after completion of 6 sessions over a total intervention period of 3 weeks.
Functional Stability (Core Stability)
Assessed using: Single Leg Balance Test Single Leg Squat Test Three-Plane Core Test These tests evaluate lumbo-pelvic-hip stability and movement control.
Time frame: Baseline assessment before intervention, midpoint assessment after 2 treatment sessions, and final assessment after completion of 6 sessions over a total intervention period of 3 weeks.
Lumbar Muscle Strength / Transversus Abdominis Activation
Measured using the Pressure Biofeedback Unit (PBU) during the abdominal drawing-in maneuver (ADIM) to assess deep core muscle activation and control.
Time frame: Baseline assessment before intervention, midpoint assessment after 2 treatment sessions, and final assessment after completion of 6 sessions over a total intervention period of 3 weeks.
Plan to share: No — Individual participant data will not be shared to protect participant confidentiality, privacy, and ethical compliance. Since the study involves sensitive personal and clinical information related to patients with nonspecific chronic low back pain, sharing raw individual-level data may increase the risk of participant identification, even after de-identification. Additionally, the informed consent provided by participants is limited to the use of data within the approved research team and for the specific purposes of this study. In accordance with institutional review board (IRB) regulations, Hamad Medical Corporation research policies, and ethical research standards, only authorized investigators will have access to the data. Therefore, only summarized and anonymized study results will be reported in publications, while individual participant data will remain confidential and securely protected.
Started Jun 2025 (actual). Primary completion is estimated for Jun 2027, 24 months after the start.
Of 60 industry-sponsored interventional studies with no phase under Low Back Pain, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 40. This study's planned 24 months is above that.
Counting every sponsor, half of 1,256 studies reached it within 11 months; a quarter within 5 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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