Ablação por Radiofrequência Pulsada e Contínua Combinada para Alívio da Dor e Sua Segurança na Dor Facetária Cervical
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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Al Fayyum, Egito, 63512
- Atef Mohamed mahmoud
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: 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 |
|
Comparador Ativo: 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 |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
neck disability index pre and post-intervention between comparison groups
Prazo: 6 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. |
6 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Duration of pain relief
Prazo: 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
Prazo: One month, 3 months, 6months, 12 months
|
Numbness, dysethesia, drop head syndrome, hypersensitivity, ataxia |
One month, 3 months, 6months, 12 months
|
|
neck disability index pre and post-intervention between comparison groups
Prazo: One month
|
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
|
|
neck disability index pre and post-intervention between comparison groups
Prazo: 3 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. |
3 months
|
|
neck disability index pre and post-intervention between comparison groups
Prazo: 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
Prazo: One month
|
of procedure, visual analog scale (VAS;0-100) |
One month
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VAS SCORE
Prazo: 3 months
|
of procedure, visual analog scale (VAS;0-100) |
3 months
|
|
VAS SCORE
Prazo: 12 months
|
of procedure, visual analog scale (VAS;0-100) |
12 months
|
|
VAS SCORE
Prazo: 6 months
|
of procedure, visual analog scale (VAS;0-100) |
6 months
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Age
Prazo: 1 hour before procedure
|
in years |
1 hour before procedure
|
|
Weight
Prazo: 1 hour before procedure
|
in Kilogram |
1 hour before procedure
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Height
Prazo: 1 hour before procedure
|
in centimeter |
1 hour before procedure
|
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Body mass index
Prazo: 1 hour before procedure
|
in kilogram/m2 |
1 hour before procedure
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Atef M Sayed, MD, Fayoum University
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
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Conclusão do estudo (Real)
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Enviado pela primeira vez que atendeu aos critérios de CQ
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Outros números de identificação do estudo
- R 333
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Data will be given on resonable request
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