Nonspecific Low Back PainMAILENCT07908693
A Novel Treatment for Chronic Low Back Pain Using Multi Angular Isometric Lumbar Exercise: Randomized Clinical Trial.
A study testing MAILE (Multi Angular Isometric Exercise) in people with Nonspecific Low Back Pain and Low Back Pain, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Nonspecific Low Back Pain, Low Back Pain, Chronic Low-back Pain (cLBP)
- What is being tested?
- MAILE (Multi Angular Isometric Exercise)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteQatar
- Study dates
- 22 Jun 2025to 22 Jun 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dr Ayman A Elmenyar, Principal Research Scientist, MD contact
Qatar1 site, 1 recruiting
- Recruiting
Outpatient Physiotherapy HMGH, Hamad Medical Corporation
Doha, 3050
Yadulla Sayed, MPT, +97455503640, Ysayed@hamad.qa
Dr Ayman A Elmenyar, Principal Research Scientist, MD, +97455347641, AELMENYAR@hamad.qa
About this study
Official title: A Novel Treatment for Nonspecific Chronic Low Back Pain Using Multi Angular Isometric Lumbar Exercise (MAILE): Randomized Clinical Trial.
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:
Read more
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.
Read the detailed description
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.
- Being tested
- MAILE (Multi Angular Isometric Exercise)
- Keywords
- Low Back Pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAILE (Multi Angular Isometric Exercise)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Multi Angular Isometric Lumbar Exercise (MAILE) | Experimental | 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 Receives: Other: MAILE (Multi Angular Isometric Exercise) |
| Core Stability and Lumbar Stabilization Exercises (CSE) | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
Pain Intensity measured using Visual Analogue Scale (VAS)
Measured: 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.
Secondary outcomes (3)
Oswestry Disability Index (ODI)
Measured using the Oswestry Disability Index (ODI) to evaluate how low back pain affects daily activities and overall function.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start22 Jun 2025
- Primary completion22 Jun 2027 (estimated)
- Study completion22 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Nonspecific Low Back PainStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- A novel treatment for nonspecific chronic low back pain Using Multi Angular Isometric Lumbar Exercise (MAILE): Randomized Clinical Trial", the Interventional Study Model is a Parallel Assignment Randomized Controlled Trial (RCT). 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. 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Mr. Yadulla Syed, Hamad Medical Corporation
- Investigators
- Yadulla Syed, MPT Ortho, Principal investigator, Hamad Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07908693
- Sponsor's protocol ID
- MRC-01-24-360
- Acronym
- MAILE
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Reiman MP, Weisbach PC, Glynn PE. The hips influence on low back pain: a distal link to a proximal problem. J Sport Rehabil. 2009 Feb;18(1):24-32. doi: 10.1123/jsr.18.1.24.
PubMed 19321904Ellison JB, Rose SJ, Sahrmann SA. Patterns of hip rotation range of motion: a comparison between healthy subjects and patients with low back pain. Phys Ther. 1990 Sep;70(9):537-41. doi: 10.1093/ptj/70.9.537.
PubMed 2144050Ben-Galim P, Ben-Galim T, Rand N, Haim A, Hipp J, Dekel S, Floman Y. Hip-spine syndrome: the effect of total hip replacement surgery on low back pain in severe osteoarthritis of the hip. Spine (Phila Pa 1976). 2007 Sep 1;32(19):2099-102. doi: 10.1097/BRS.0b013e318145a3c5.
PubMed 17762811Carey TS, Garrett JM, Jackman A, Hadler N. Recurrence and care seeking after acute back pain: results of a long-term follow-up study. North Carolina Back Pain Project. Med Care. 1999 Feb;37(2):157-64. doi: 10.1097/00005650-199902000-00006.
PubMed 10024120Bergquist-Ullman M, Larsson U. Acute low back pain in industry. A controlled prospective study with special reference to therapy and confounding factors. Acta Orthop Scand. 1977;(170):1-117. doi: 10.3109/ort.1977.48.suppl-170.01. No abstract available.
PubMed 146394Von Korff M, Saunders K. The course of back pain in primary care. Spine (Phila Pa 1976). 1996 Dec 15;21(24):2833-7; discussion 2838-9. doi: 10.1097/00007632-199612150-00004.
PubMed 9112707Bener A, Dafeeah EE, Alnaqbi K, Falah O, Aljuhaisi T, Sadeeq A, Khan S, Schlogl J. An epidemiologic analysis of low back pain in primary care: a hot humid country and global comparison. J Prim Care Community Health. 2013 Jul 1;4(3):220-7. doi: 10.1177/2150131913479385. Epub 2013 Feb 19.
PubMed 23799711Elnaggar RK, Elshazly FA, Elsayed WS, Ahmed AS. "Determinants and relative risks of low back pain among the employees in Al-Kharj area, Saudi Arabia." European Journal of Scientific Research. 2015;135(3):299-308
Casser HR, Seddigh S, Rauschmann M. Acute Lumbar Back Pain. Dtsch Arztebl Int. 2016 Apr 1;113(13):223-34. doi: 10.3238/arztebl.2016.0223.
PubMed 27120496Walker BF. The prevalence of low back pain: a systematic review of the literature from 1966 to 1998. J Spinal Disord. 2000 Jun;13(3):205-17. doi: 10.1097/00002517-200006000-00003.
PubMed 10872758GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1211-1259. doi: 10.1016/S0140-6736(17)32154-2.
PubMed 28919117Rhyu HS, Park HK, Park JS, Park HS. The effects of isometric exercise types on pain and muscle activity in patients with low back pain. J Exerc Rehabil. 2015 Aug 30;11(4):211-4. doi: 10.12965/jer.150224. eCollection 2015 Aug.
PubMed 26331136Kim B, Yim J. Core Stability and Hip Exercises Improve Physical Function and Activity in Patients with Non-Specific Low Back Pain: A Randomized Controlled Trial. Tohoku J Exp Med. 2020 Jul;251(3):193-206. doi: 10.1620/tjem.251.193.
PubMed 32669487Kent PM, Keating JL. The epidemiology of low back pain in primary care. Chiropr Osteopat. 2005 Jul 26;13:13. doi: 10.1186/1746-1340-13-13.
PubMed 16045795Vrbanic TS. [Low back pain--from definition to diagnosis]. Reumatizam. 2011;58(2):105-7. Croatian.
PubMed 22232956
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Treatment for Nonspecific Chronic Low Back Pain Using Multi Angular Isometric Lumbar Exercise (MAILE): Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT07908693
- Acronym / sponsor ID
- MAILE / MRC-01-24-360
- Keywords
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2025 (actual)
- Primary completion
- 22 Jun 2027 (estimated)
- Study completion
- 22 Jun 2027 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A novel treatment for nonspecific chronic low back pain Using Multi Angular Isometric Lumbar Exercise (MAILE): Randomized Clinical Trial", the Interventional Study Model is a Parallel Assignment Randomized Controlled Trial (RCT). 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. 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.
| Arm | Type | Receives |
|---|---|---|
| Multi Angular Isometric Lumbar Exercise (MAILE) | Experimental | Other: MAILE (Multi Angular Isometric Exercise)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 |
| Core Stability and Lumbar Stabilization Exercises (CSE) | No intervention | –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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
- 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
- Be willing and able to safely participate in an exercise program Have no cognitive impairment limiting participation
Key exclusion criteria (6 listed)
- 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
- 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
- Rheumatologic disorders Spinal infections Prior back surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAILE (Multi Angular Isometric Exercise)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. | Other | Multi Angular Isometric Lumbar Exercise (MAILE) |
Primary outcome
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.
Pain Intensity measured using Visual Analogue Scale (VAS)
3 secondary outcomes
Oswestry Disability Index (ODI)
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)
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: PubMed 19321904Reiman MP, Weisbach PC, Glynn PE. The hips influence on low back pain: a distal link to a proximal problem. J Sport Rehabil. 2009 Feb;18(1):24-32. doi: 10.1123/jsr.18.1.24.
- Results publication: PubMed 2144050Ellison JB, Rose SJ, Sahrmann SA. Patterns of hip rotation range of motion: a comparison between healthy subjects and patients with low back pain. Phys Ther. 1990 Sep;70(9):537-41. doi: 10.1093/ptj/70.9.537.
- Results publication: PubMed 17762811Ben-Galim P, Ben-Galim T, Rand N, Haim A, Hipp J, Dekel S, Floman Y. Hip-spine syndrome: the effect of total hip replacement surgery on low back pain in severe osteoarthritis of the hip. Spine (Phila Pa 1976). 2007 Sep 1;32(19):2099-102. doi: 10.1097/BRS.0b013e318145a3c5.
- Results publication: PubMed 10024120Carey TS, Garrett JM, Jackman A, Hadler N. Recurrence and care seeking after acute back pain: results of a long-term follow-up study. North Carolina Back Pain Project. Med Care. 1999 Feb;37(2):157-64. doi: 10.1097/00005650-199902000-00006.
- Results publication: PubMed 146394Bergquist-Ullman M, Larsson U. Acute low back pain in industry. A controlled prospective study with special reference to therapy and confounding factors. Acta Orthop Scand. 1977;(170):1-117. doi: 10.3109/ort.1977.48.suppl-170.01. No abstract available.
- Results publication: PubMed 9112707Von Korff M, Saunders K. The course of back pain in primary care. Spine (Phila Pa 1976). 1996 Dec 15;21(24):2833-7; discussion 2838-9. doi: 10.1097/00007632-199612150-00004.
- Results publication: PubMed 23799711Bener A, Dafeeah EE, Alnaqbi K, Falah O, Aljuhaisi T, Sadeeq A, Khan S, Schlogl J. An epidemiologic analysis of low back pain in primary care: a hot humid country and global comparison. J Prim Care Community Health. 2013 Jul 1;4(3):220-7. doi: 10.1177/2150131913479385. Epub 2013 Feb 19.
- Results publicationElnaggar RK, Elshazly FA, Elsayed WS, Ahmed AS. "Determinants and relative risks of low back pain among the employees in Al-Kharj area, Saudi Arabia." European Journal of Scientific Research. 2015;135(3):299-308
- Results publication: PubMed 27120496Casser HR, Seddigh S, Rauschmann M. Acute Lumbar Back Pain. Dtsch Arztebl Int. 2016 Apr 1;113(13):223-34. doi: 10.3238/arztebl.2016.0223.
- Results publication: PubMed 10872758Walker BF. The prevalence of low back pain: a systematic review of the literature from 1966 to 1998. J Spinal Disord. 2000 Jun;13(3):205-17. doi: 10.1097/00002517-200006000-00003.
- Results publication: PubMed 28919117GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1211-1259. doi: 10.1016/S0140-6736(17)32154-2.
- Results publication: PubMed 26331136Rhyu HS, Park HK, Park JS, Park HS. The effects of isometric exercise types on pain and muscle activity in patients with low back pain. J Exerc Rehabil. 2015 Aug 30;11(4):211-4. doi: 10.12965/jer.150224. eCollection 2015 Aug.
- Individual participant dataSharing planned: 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.
Related trials for Nonspecific Low Back Pain
Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP
Not yet recruiting
Dual-Task Core Stabilization Training in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low Back Pain
Not yet recruiting
Gamified Home-Based Core Neuromuscular Training for Chronic Low Back Pain
Low Back Pain, Core Muscles
Not yet recruiting
Visual Feedback-Assisted Sensorimotor Training in Chronic Nonspecific Low Back Pain
Chronic Low Back Pain
RecruitingObservational study
Pain Catastrophizing, Fear of Movement, and Physical Activity in Postmenopausal Women With Chronic Low Back Pain
Low Back Pain, Postmenopause Women
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr Ayman A Elmenyar, Principal Research Scientist, MD contact
Yadulla Syed, MPT Ortho principal investigator
Hamad Medical Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAILE (Multi Angular Isometric Exercise) in people with Nonspecific Low Back Pain and Low Back Pain, run by Hamad Medical Corporation at 1 site in Qatar.
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 6 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: looking for participants now, as of the sponsor's last update on 2 Nov 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 Qatar. 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 Yadulla Syed, MPT (+97455503640, Ysayed@hamad.qa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07908693, which also lists 15 linked publications.
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 2 Nov 2026.