Fluoroscopy-Guided Lumbar Facet Block for Chronic Low Back Pain
Evaluation of Functionality and Pain After Fluoroscopy-Guided Lumbar Facet Block: A Prospective and Longitudinal Study
This prospective, longitudinal observational study evaluates functional recovery, pain intensity, and lumbar mobility after a fluoroscopy-guided lumbar facet joint block in patients with chronic lumbar facet syndrome. Forty patients receiving standard-of-care injections (ropivacaine 0.2% and methylprednisolone) will be observed. Outcomes are measured at baseline and 30 days post-intervention. The primary outcome is the change in Oswestry Disability Index (ODI). Secondary outcomes include changes in the Numeric Rating Scale (NRS) and the modified Schober test.
연구 개요
상세 설명
Chronic low back pain due to facet joint arthropathy is a common cause of disability.
Fluoroscopy-guided facet joint blocks are widely used in standard practice, but evidence quantifying objective functional and biomechanical recovery beyond pain reduction is limited.
This single-center, prospective, observational, longitudinal study aims to objectively quantify functional recovery. Forty patients aged 18-75 years with clinically and radiologically confirmed lumbar facet syndrome will be observed. The intervention (unilateral fluoroscopy-guided injection of ropivacaine 0.2% [0.5-1 mL] and methylprednisolone into the affected facet joint) is performed strictly as part of routine clinical care, independent of study inclusion.
Assessments occur at baseline (T0) and 30 days post-injection (T1). The primary outcome is the change in Oswestry Disability Index (ODI) score. Secondary outcomes are changes in Numeric Rating Scale (NRS) pain scores and the modified Schober test (cm). Adverse events and procedural safety are recorded. The study aims to provide preliminary effect estimates to inform future controlled trials.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Paola Estefania Vallejo Mora, MD
- 전화번호: +52 56 3125 6766
- 이메일: paovallejo100177@gmail.com
연구 연락처 백업
- 이름: Sergio Tenopala Villegas, MD
- 전화번호: +52 55 5412 0375
- 이메일: drstenopala@yahoo.com.mx
연구 장소
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Mexico City
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Mexico City, Mexico City, 멕시코, 03229
- Centro Médico Nacional 20 de Noviembre, ISSSTE
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연락하다:
- Paola Estefania Vallejo Mora, MD
- 전화번호: +52 56 3125 6766
- 이메일: paovallejo100177@gmail.com
-
연락하다:
- Sergio Tenopala Villegas, MD
- 전화번호: +52 55 5412 0375
- 이메일: drstenopala@yahoo.com.mx
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Adults aged 18-75 years with chronic low back pain (>3 months) due to lumbar facet syndrome confirmed by clinical examination and imaging, presenting to the Algology outpatient clinic.
설명
Inclusion Criteria:
- Age 18-75 years
- Clinical and radiological diagnosis of lumbar facet syndrome
- Low back pain duration >3 months
- Baseline NRS pain score ≥4/10
- Signed informed consent for the procedure and study participation
- Cognitive capacity to independently complete the Oswestry Disability Index
Exclusion Criteria:
- Radicular pain or confirmed disc herniation with neural compression
- Coagulopathy or use of anticoagulants not discontinued appropriately
- Active systemic or local infection
- Known allergy to local anaesthetics or corticosteroids
- Pregnancy or lactation
- Previous lumbar spine surgery at the same level
- Inability to comply with follow-up schedule
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Facet Block
Single group receiving standard-of-care fluoroscopy-guided lumbar facet joint injection of ropivacaine 0.2% (0.5-1 mL) and methylprednisolone into the affected facet joint(s). |
Under fluoroscopic guidance, a 20G Quincke needle is placed into the target lumbar facet joint or onto the adjacent medial branch. An arthrogram is performed with 0.3 to 0.5 mL of non-ionic contrast to confirm correct dispersion and exclude vascular/intrathecal uptake. Subsequently, 0.5 to 1 mL of a mixture containing ropivacaine 0.2% and methylprednisolone is injected per level. Performed on an outpatient basis under standard monitoring. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Oswestry Disability Index (ODI)
기간: Baseline (pre-injection) and 30 days post-injection
|
The Oswestry Disability Index (ODI) is a 10-item questionnaire that measures functional disability in daily activities (0% = no disability, 100% = severe disability). The primary outcome is the change in ODI score from baseline to 30 days. A reduction of ≥10 points is considered clinically significant. |
Baseline (pre-injection) and 30 days post-injection
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Numeric Rating Scale (NRS) pain score
기간: Baseline, immediately post-procedure, and 30 days post-injection
|
Pain intensity measured using an 11-point Numeric Rating Scale (0 = no pain, 10 = worst imaginable pain). A clinically significant reduction is defined as at least a 50% decrease from the baseline score. |
Baseline, immediately post-procedure, and 30 days post-injection
|
|
Change in modified Schober test (lumbar flexion mobility)
기간: Baseline and 30 days post-injection
|
The modified Schober test measures lumbar flexion range (cm) to evaluate biomechanical mobility. An increase of at least 5 cm indicates a functional range. |
Baseline and 30 days post-injection
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Incidence of adverse events
기간: Immediately after procedure up to 30 days post-injection
|
Record of any adverse events including pain at injection site, transient exacerbation of pain, allergic reaction, inadvertent dural puncture, spinal haematoma, or nerve root injury. |
Immediately after procedure up to 30 days post-injection
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Sergio Tenopala Villegas, MD, Centro Médico Nacional 20 de Noviembre, ISSSTE
- 부수사관: Paola Estefania Vallejo Mora, MD, Centro Médico Nacional 20 de Noviembre, ISSSTE
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
기타 연구 ID 번호
- RAI.CMN.373.2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
De-identified individual participant data underlying the results reported in this study, along with the full analysis code, will be made available following article publication via the corresponding author's public GitHub repository.
IPD 공유 기간
Beginning at the time of article publication, with no end date.
IPD 공유 액세스 기준
Data and code will be publicly available with no access restrictions via GitHub.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- ANALYTIC_CODE
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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