Kombinert kontinuerlig og pulsert radiofrekvensablasjon for smertelindring og deres sikkerhet ved cervikal fasettsmerte
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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Al Fayyum, Egypt, 63512
- Atef Mohamed mahmoud
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: 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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Aktiv komparator: 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 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
neck disability index pre and post-intervention between comparison groups
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Duration of pain relief
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
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VAS SCORE
Tidsramme: One month
|
of procedure, visual analog scale (VAS;0-100) |
One month
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VAS SCORE
Tidsramme: 3 months
|
of procedure, visual analog scale (VAS;0-100) |
3 months
|
|
VAS SCORE
Tidsramme: 12 months
|
of procedure, visual analog scale (VAS;0-100) |
12 months
|
|
VAS SCORE
Tidsramme: 6 months
|
of procedure, visual analog scale (VAS;0-100) |
6 months
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Age
Tidsramme: 1 hour before procedure
|
in years |
1 hour before procedure
|
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Weight
Tidsramme: 1 hour before procedure
|
in Kilogram |
1 hour before procedure
|
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Height
Tidsramme: 1 hour before procedure
|
in centimeter |
1 hour before procedure
|
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Body mass index
Tidsramme: 1 hour before procedure
|
in kilogram/m2 |
1 hour before procedure
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Atef M Sayed, MD, Fayoum University
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- R 333
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
Data will be given on resonable request
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