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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: fatima A Alowais, PT
- 전화번호: +971566663372
- 이메일: fatimaalowais7@gmail.com
연구 연락처 백업
- 이름: Tamer shousha, PhD
- 전화번호: +971562224469
- 이메일: tshousha@sharjah.ac.ae
연구 장소
-
-
Emirate of Sharjah
-
Sharjah city, Emirate of Sharjah, 아랍 에미리트
- Al Qassimi Hospital
-
연락하다:
- fatima A Alowais, PT
- 전화번호: +971566663372
- 이메일: fatimaalowais7@gmail.com
-
연락하다:
- Tamer shousha, PhD
- 전화번호: +971562224469
- 이메일: tshousha@sharjah.ac.ae
-
수석 연구원:
- Tamer Shousha, Phd
-
부수사관:
- fatima Alowais, PT
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
|
활성 비교기: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Lumbar Nerve Root Fractional Anisotropy
기간: Baseline and Week 12
|
Change in lumbar nerve root microstructural integrity measured using Diffusion Tensor Imaging (DTI) Fractional Anisotropy.
|
Baseline and Week 12
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pain Intensity
기간: Baseline and Week 12
|
Measured using Numeric Pain Rating Scale (0-10).
|
Baseline and Week 12
|
|
Spinal Alignment
기간: Baseline and Week 12
|
Measured using digital posture analysis.
|
Baseline and Week 12
|
|
Additional DTI Parameters
기간: Baseline and Week 12
|
Mean Diffusivity, Axial Diffusivity, and Radial Diffusivity.
|
Baseline and Week 12
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- UOS-PHD-LRDTI-2026-01
- U25103971 (기타 식별자: University of Sharjah)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .