경추 후관절 통증의 통증 완화 및 안전을 위한 결합된 지속 및 펄스 고주파 절제
Continuous Versus Combined Continuous and Pulsed Radiofrequency Ablation for Pain Relief and Safety in Cervical Facet-Mediated Pain: A Prospective Randomized Study
Continuous radiofrequency ablation (CRF) is the effective management for cervical facet joint pain but related with neuropathic symptoms in post-radiofrequency period. Additionally, pulse radiofrequency ablation (PRF) provides relief of neuropathic symptoms. However, the effect of CRF followed by PRF has yet to be validated
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
One prevalent and incapacitating problem seen in pain treatment therapy is chronic neck pain originating from the cervical facet joints. (1). Cervical facet joint pain was shown to be 49% common in a recent study (2). Depending on the level of the cervical facet joint, a facet referral pattern is characteristic of cervical facet joint discomfort (3,4). Radiofrequency (RF) ablation of the medial branch nerves is a proven, minimally invasive therapeutic option for long-lasting pain alleviation once a good response to diagnostic cervical medial branch blocks validates the diagnosis. Cervical facet joint pain has been successfully treated with traditional continuous radiofrequency ablation (RFA) of the cervical medial branches (5). Regretfully, even with sufficient analgesia, over 40% of patients undergoing RFA experience negative side effects, including post-procedural sensory side effects like numbness, dysesthesia, and hypersensitivity. 6,7). As a result, Continuous radiofrequency ablation (CRF) is the established minimally invasive treatment for chronic facet-mediated spinal pain once diagnostic medial branch blocks confirm the pain source, producing a thermal lesion at the target nerve to interrupt nociceptive transmission. Manchikanti et al. rated continuous RFA as Level II evidence for managing chronic spinal pain from the facet joints, reflecting its established role in clinical practice (6). However, despite its efficacy, more than 40% of patients undergoing CRF of the cervical medial branches experience post-procedural sensory side effects such as numbness, dysesthesia, and hypersensitivity (7,8) prompting interest in alternative radiofrequency strategies that preserve analgesic benefit while reducing these neuropathic effects. Combining continuous and pulsed radiofrequency (CPRF) has been proposed as a strategy to preserve the analgesic effect achieved with thermal ablation while reducing the incidence of post-procedural neuropathic side effects through the added neuromodulatory pulsed phase (9). However, there are no studies comparing the effectiveness and safety of pulse versus combined radiofrequency ablation in the cervical facet joint. This study was designed to compare the effectiveness and safety of continuous radiofrequency (CRF) alone versus combined continuous and pulsed radiofrequency (CPRF) in patients with chronic cervical facet joint pain.
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
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Al Fayyum, 이집트, 63512
- Atef Mohamed mahmoud
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients age from (30-75) years.
- American Society of Anesthesiologists (ASA) physical status class I or II
- ≥ 4 points on the verbal numeric rating scale (VNRS) (scored from 0 = no pain to 100 = worst pain imaginable)) before RF stimulation of the cervical medial branches;
- Patients presenting with a positive diagnostic cervical medial branche block defined as pain relief more than 50% from baseline.
Exclusion Criteria:
- Repeated cervical radiofrequency ablation.
- Patients presenting neck pain with radicular symptoms.
- Previous cervical discectomy or fixation surgery.
- Malignancy.
- local infection
- Psychological problem.
- language barrier.
- History of allergy to radio-opaque contrast solution,lidocaine or bupivacaine. - Inadequate medical proplem (hepatic, renal, cardiac) patients.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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활성 비교기: Flouroscopic guidance cervical medial branch continous RF ablation
After the patient lying prone we obtaining the posterior approach with PA view then lateral 15 degrees the C shaped edge of the cervical vertebrae were appeared and then we advance the needle till reaching this C shaped till hitting the bone then slipping the active tip slightly therafter we obtaining lateral view to determine the depth of the needle over the cervical pedicle. patients in the continous radiofrequency group will be underwent continous radiofrequency at 80°C for 90 seconds for 2 cycles |
Electromagnetic wave deposition near nerve tissue for pain management |
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활성 비교기: Flouroscopic guidance cervical medial branch combined pulsed and continous RF ablation
After the patient lying prone we obtaining the posterior approach with PA view then lateral 15 degrees the C shaped edge of the cervical vertebrae were appeared and then we advance the needle till reaching this C shaped till hitting the bone then slipping the active tip slightly therafter we obtaining lateral view to determine the depth of the needle over the cervical pedicle. patients in the continous and pulsed group will be underwent continous and pulsed radiofrequency at 80°C for 90 seconds for 1 cycle followed by pulsed radiofrequency at 42°C for 120 seconds for 1 cycle |
Electromagnetic wave deposition near nerve tissue for pain management |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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neck disability index pre and post-intervention between comparison groups
기간: 6 months
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Neck disability index : It contains ten sectors: seven sectors related to everyday existing behaviors, two sectors correlated to pain, and one sector correlated to concentration. All items are marked from 0 to 5. A mark of 0 denotes the maximum level of function, while a mark of 5 indicates the bottom level of function. The maximum mark is 50, and a greater mark relates to an increased level of disability. |
6 months
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Duration of pain relief
기간: One month, 3months,6 months, 12 months
|
The duration of pain relief was expressed as the period between pain relief and pain reoccurrence to 50% of pre-procedural pain level |
One month, 3months,6 months, 12 months
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Complications
기간: One month, 3 months, 6months, 12 months
|
Numbness, dysethesia, drop head syndrome, hypersensitivity, ataxia |
One month, 3 months, 6months, 12 months
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neck disability index pre and post-intervention between comparison groups
기간: One month
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Neck disability index : It contains ten sectors: seven sectors related to everyday existing behaviors, two sectors correlated to pain, and one sector correlated to concentration. All items are marked from 0 to 5. A mark of 0 denotes the maximum level of function, while a mark of 5 indicates the bottom level of function. The maximum mark is 50, and a greater mark relates to an increased level of disability. |
One month
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neck disability index pre and post-intervention between comparison groups
기간: 3 months
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Neck disability index : It contains ten sectors: seven sectors related to everyday existing behaviors, two sectors correlated to pain, and one sector correlated to concentration. All items are marked from 0 to 5. A mark of 0 denotes the maximum level of function, while a mark of 5 indicates the bottom level of function. The maximum mark is 50, and a greater mark relates to an increased level of disability. |
3 months
|
|
neck disability index pre and post-intervention between comparison groups
기간: 12 months
|
Neck disability index : It contains ten sectors: seven sectors related to everyday existing behaviors, two sectors correlated to pain, and one sector correlated to concentration. All items are marked from 0 to 5. A mark of 0 denotes the maximum level of function, while a mark of 5 indicates the bottom level of function. The maximum mark is 50, and a greater mark relates to an increased level of disability. |
12 months
|
|
VAS SCORE
기간: One month
|
of procedure, visual analog scale (VAS;0-100) |
One month
|
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VAS SCORE
기간: 3 months
|
of procedure, visual analog scale (VAS;0-100) |
3 months
|
|
VAS SCORE
기간: 12 months
|
of procedure, visual analog scale (VAS;0-100) |
12 months
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VAS SCORE
기간: 6 months
|
of procedure, visual analog scale (VAS;0-100) |
6 months
|
기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Age
기간: 1 hour before procedure
|
in years |
1 hour before procedure
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Weight
기간: 1 hour before procedure
|
in Kilogram |
1 hour before procedure
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Height
기간: 1 hour before procedure
|
in centimeter |
1 hour before procedure
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Body mass index
기간: 1 hour before procedure
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in kilogram/m2 |
1 hour before procedure
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공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Atef M Sayed, MD, Fayoum University
간행물 및 유용한 링크
일반 간행물
- Manchikanti L, Kaye AD, Boswell MV, Bakshi S, Gharibo CG, Grami V, Grider JS, Gupta S, Jha SS, Mann DP, Nampiaparampil DE, Sharma ML, Shroyer LN, Singh V, Soin A, Vallejo R, Wargo BW, Hirsch JA. A Systematic Review and Best Evidence Synthesis of the Effectiveness of Therapeutic Facet Joint Interventions in Managing Chronic Spinal Pain. Pain Physician. 2015 Jul-Aug;18(4):E535-82.
- Ojeda Nino A, Manterola Lasa O, Gracia Fabre C, Nebreda-Clavo CL, Ferreira-Dos-Santos G, Armand-Ugon R. Dropped head syndrome after bilateral cervical radiofrequency ablation. A case report and literature review. Interv Pain Med. 2024 Apr 16;3(2):100409. doi: 10.1016/j.inpm.2024.100409. eCollection 2024 Jun.
- Barnsley L, Lord S, Bogduk N. Comparative local anaesthetic blocks in the diagnosis of cervical zygapophysial joint pain. Pain. 1993 Oct;55(1):99-106. doi: 10.1016/0304-3959(93)90189-V.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- R 333
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Data will be given on resonable request
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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