NCT07558993

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 30, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

12 months

First QC Date

April 23, 2026

Last Update Submit

April 23, 2026

Conditions

Keywords

Mirror Image ExercisePhysiotherapyDiffusion Tensor ImagingDTIConservative PhysiotherapyLow Back PainNerve Root CompressionPostural CorrectionRandomized Controlled TrialRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Lumbar Nerve Root Fractional Anisotropy

    Change in lumbar nerve root microstructural integrity measured using Diffusion Tensor Imaging (DTI) Fractional Anisotropy.

    Baseline and Week 12

Secondary Outcomes (3)

  • Pain Intensity

    Baseline and Week 12

  • Spinal Alignment

    Baseline and Week 12

  • Additional DTI Parameters

    Baseline and Week 12

Study Arms (2)

Mirror Image Spine Correction Exercises

EXPERIMENTAL

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.

Behavioral: Mirror Image Spine Correction Exercises

Conservative Physiotherapy

ACTIVE COMPARATOR

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.

Behavioral: Conservative Physiotherapy

Interventions

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.

Mirror Image Spine Correction Exercises

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.

Conservative Physiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Qassimi Hospital

Sharjah city, Emirate of Sharjah, United Arab Emirates

Location

Related Publications (2)

  • Tarulli AW, Raynor EM. Lumbosacral radiculopathy. Neurol Clin. 2007 May;25(2):387-405. doi: 10.1016/j.ncl.2007.01.008.

    PMID: 17445735BACKGROUND
  • Rubin DI. Epidemiology and risk factors for spine pain. Neurol Clin. 2007 May;25(2):353-71. doi: 10.1016/j.ncl.2007.01.004.

    PMID: 17445733BACKGROUND

Related Links

MeSH Terms

Conditions

RadiculopathySciaticaIntervertebral disc diseaseLow Back Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesSciatic NeuropathyMononeuropathiesNeuralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBack Pain

Central Study Contacts

Fatima A Alowais, PT

CONTACT

Tamer shousha, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors and imaging analysts will be blinded to group allocation where feasible. Participants and treating physiotherapists cannot be blinded due to the nature of exercise interventions.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel treatment groups: Mirror Image Spine Correction Exercises or standardized conservative physiotherapy for 12 weeks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Physiotherapy, Principal Investigator

Study Record Dates

First Submitted

April 23, 2026

First Posted

April 30, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

De-identified individual participant data may be shared upon reasonable request after publication, subject to ethics approval, institutional policy, and participant confidentiality protections.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
De-identified individual participant data and supporting documents will be available beginning 6 months after publication of the primary study results and will remain available for at least 5 years thereafter, subject to institutional data retention policies.
Access Criteria
Qualified researchers with a methodologically sound proposal may request access to de-identified individual participant data, study protocol, statistical analysis plan, informed consent materials, and analytic code. Requests will be reviewed by the study investigators and institution to ensure scientific merit, participant confidentiality, and compliance with ethical approvals. Data will be shared through secure controlled-access electronic transfer following approval of a data use agreement where required.

Locations