- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07558993
Mirror Image Spine Correction Exercises Versus Conservative Physiotherapy for Lumbar Radiculopathy (MIRROR-LR)
Randomized, Parallel-Group, Superiority Trial of Mirror Image Spine Correction Exercises Versus Conservative Physiotherapy for Lumbar Nerve Root Microstructural Integrity Assessed by Diffusion Tensor Imaging in Adults With Lumbar Radiculopathy
Lumbar radiculopathy is a common condition caused by irritation or compression of a lumbar nerve root, often resulting in radiating leg pain, numbness, weakness, and functional limitation. Conservative physiotherapy is commonly used as first-line treatment, but outcomes vary among patients.
This randomized controlled trial will compare Mirror Image Spine Correction Exercises with standardized conservative physiotherapy in adults with lumbar radiculopathy. Participants will be randomly assigned to one of two treatment groups for 12 weeks.
The primary outcome is lumbar nerve root microstructural integrity measured using Diffusion Tensor Imaging (DTI), including Fractional Anisotropy and other diffusion parameters. Secondary outcomes include pain intensity, disability, spinal alignment, and adverse events.
The purpose of this study is to determine whether a targeted posture-correction exercise approach provides greater improvement than conventional physiotherapy.
Study Overview
Status
Intervention / Treatment
Detailed Description
Lumbar radiculopathy is a neuromusculoskeletal disorder commonly caused by lumbar disc herniation or foraminal stenosis leading to nerve root irritation or compression. Symptoms commonly include radiating leg pain, paresthesia, weakness, altered reflexes, and reduced physical function.
Conservative physiotherapy is recommended as first-line management and may include education, graded exercise, mobility restoration, strengthening, neural mobilization, and symptom management. However, treatment response is heterogeneous, and many patients continue to experience persistent symptoms.
Most previous rehabilitation studies have relied primarily on patient-reported outcomes such as pain and disability. These measures are clinically important but may not fully reflect biological recovery of the affected nerve root.
Diffusion Tensor Imaging (DTI) is an advanced magnetic resonance imaging technique that can quantify neural tissue microstructure. Parameters such as Fractional Anisotropy (FA), Mean Diffusivity (MD), Axial Diffusivity (AD), and Radial Diffusivity (RD) may provide objective markers of nerve recovery.
Mirror Image Spine Correction Exercises are individualized posture-based exercises designed to move the trunk or pelvis opposite to identified alignment deviations. This approach may improve biomechanics, reduce abnormal loading, and decrease neural irritation.
This study is a prospective randomized, parallel-group, superiority trial. Eligible adults with unilateral lumbar radiculopathy will be randomly allocated in a 1:1 ratio to:
Mirror Image Spine Correction Exercise group Standardized Conservative Physiotherapy group Both groups will receive supervised treatment sessions three times per week for 12 weeks.
Primary Outcome:
Change in lumbar nerve root microstructural integrity measured by DTI at baseline and week 12.
Secondary Outcomes:
Pain intensity Disability (Oswestry Disability Index) Spinal alignment Safety outcomes and adverse events The study aims to determine whether Mirror Image Spine Correction Exercises produce superior clinical and imaging outcomes compared with conservative physiotherapy.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: fatima A Alowais, PT
- Phone Number: +971566663372
- Email: fatimaalowais7@gmail.com
Study Contact Backup
- Name: Tamer shousha, PhD
- Phone Number: +971562224469
- Email: tshousha@sharjah.ac.ae
Study Locations
-
-
Emirate of Sharjah
-
Sharjah city, Emirate of Sharjah, United Arab Emirates
- Al Qassimi Hospital
-
Contact:
- fatima A Alowais, PT
- Phone Number: +971566663372
- Email: fatimaalowais7@gmail.com
-
Contact:
- Tamer shousha, PhD
- Phone Number: +971562224469
- Email: tshousha@sharjah.ac.ae
-
Principal Investigator:
- Tamer Shousha, Phd
-
Sub-Investigator:
- fatima Alowais, PT
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 18 years or older. Clinical diagnosis of unilateral lumbar radiculopathy. Presence of at least two of the following: dermatomal radiating leg pain, neurological deficit, positive neural tension test.
MRI-confirmed lumbar nerve root compression or irritation consistent with symptoms.
Pain intensity of 3/10 or greater. Able to undergo MRI and Diffusion Tensor Imaging (DTI). Able to understand study procedures and provide written informed consent.
Exclusion Criteria:
- Previous lumbar spine surgery. Bilateral radiculopathy or unclear diagnosis. Tumor, infection, fracture, inflammatory spinal disease, or cauda equina syndrome.
Severe progressive neurological deficit requiring urgent treatment. Contraindications to MRI (pacemaker, incompatible implants, severe claustrophobia).
Recent lumbar injections or surgery. Other neurological or musculoskeletal disorders affecting outcomes. Pregnancy if MRI contraindicated by local policy. Cognitive impairment or inability to follow instructions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mirror Image Spine Correction Exercises
Participants will receive a supervised individualized Mirror Image Spine Correction Exercise program three sessions per week for 12 weeks.
Exercises will be based on postural alignment findings and include a prescribed home exercise program.
|
Participants will receive an individualized supervised exercise program based on identified postural alignment deviations.
Treatment will be delivered three sessions per week for 12 weeks and may include trunk and pelvic corrective movements, mobility, stabilization, and a prescribed home exercise program.
|
|
Active Comparator: Conservative Physiotherapy
Participants will receive standardized conservative physiotherapy three sessions per week for 12 weeks including education, graded exercise, mobility training, strengthening, and clinically indicated adjunctive techniques.
|
Participants will receive standardized conservative physiotherapy three sessions per week for 12 weeks including education, graded exercise, mobility exercises, strengthening, neural mobilization, and clinically indicated adjunctive non-invasive techniques.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lumbar Nerve Root Fractional Anisotropy
Time Frame: Baseline and Week 12
|
Change in lumbar nerve root microstructural integrity measured using Diffusion Tensor Imaging (DTI) Fractional Anisotropy.
|
Baseline and Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity
Time Frame: Baseline and Week 12
|
Measured using Numeric Pain Rating Scale (0-10).
|
Baseline and Week 12
|
|
Spinal Alignment
Time Frame: Baseline and Week 12
|
Measured using digital posture analysis.
|
Baseline and Week 12
|
|
Additional DTI Parameters
Time Frame: Baseline and Week 12
|
Mean Diffusivity, Axial Diffusivity, and Radial Diffusivity.
|
Baseline and Week 12
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UOS-PHD-LRDTI-2026-01
- U25103971 (Other Identifier: University of Sharjah)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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