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Completed

NCT Number: NCT05719948

Combined Continuous and Pulsed Radiofrequency Ablation for Pain Relief and Their Safety in Cervical Facet Pain

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

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Key information

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atef Mohamed mahmoud

Al Fayyum, 63512, Egypt

About this study

Diagnostic procedure symptomatic facet joint was designated according to pain referral. Also, medial branches were injected with 2% lidocaine 0.3 ml per site.

Treatment procedure The posterior technique was first described in 1995 . All interventions assessed the intravenous saline lock on arrival at the outpatient department using pulse oximetry and noninvasive blood pressure monitoring and intravenous sedation as required. Patients were assigned in a prone position under C-ARM fluoroscopic guidance with a Neurotherm NT 2000 Lesion Generator the (USA manufactured) . The electrode pad of the radiofrequency equipment was attached to the ipsilateral side of the posterior thigh. After the skin was then anesthetized with 1% lidocaine, a 20-gauge, 10-cm cannula with 10-mm curved active tip (Diros RF Cannula, Diros Technology Inc., Canada) was inserted along a 15 to 30 degree angle to the sagittal plane (slightly posterior oblique approach) . The cannula was applied until reaching the lateral part of the articular pillar . Then the depth of the cannula was checked using a lateral view. A probe was inserted through the cannula and linked to a radiofrequency generator (Diros Technology OWL, Canada). After impedance were accomplished at below 500 Ohm, sensory stimulation was performed at 50 Hz and the patient reported not feeling any tingling sensation along the distribution of dermatome. Consequently, a motor stimulation (2 Hz) was executed until multifidus twitching was presented at stimulation less than 1 volts and no motor twitching was observed along the myotome. A non-ionic contrast medium was injected to ensure the intravascular injection before 1% lidocaine 0.5 ml was injected after the needle reached the desired location. The study investigated two lesions due to the anatomical variation of the medial branches. Patients in the CRF group (n = 16) underwent CRF at 80°C for 90 seconds for 2 cycles. Patients in the CPRF group underwent CRF at 80°C for 90 seconds for 1 cycle followed by PRF at 42°C for 120 seconds for 1 cycle. 0.125% bupivacaine plus 2 mg of dexamethasone in a total volume of 1 mL were injected after lesioning had performed.

Measurement The demographic data including age, sex, comorbidities, body mass index (BMI), level of procedure, visual analog scale (VAS;1-100) Neck Pain Disability Index and complications were reviewed. 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. The NDI scores were recorded before intervention and first month, third month, sixth month, ninth months and 12 months after intervention. The follow-up was performed either face to face or by phone, and patients were not permitted to use over-the counter analgesic medication. The primary outcome was number of patients who had successful treatment, expressed as at least 80% pain relief from baseline and NDI score less than 15 for at least 3 months . The secondary outcomes comprised the duration of pain relief defined as the time of pain relief until VAS had restored to at least 50% from baseline and side effects including numbness, ataxia, dysesthesia, hypersensitivity, itching and muscular weakness (dropped head syndrome) between group comparisons. A research assistant, who was uninvolved in the intervention or post-operative follow-up, collected all data in prospective medical records.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients age from (30-75) years old.
  • ASA ( I, II).
  • Patients presenting 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.

Treatment and study plan

Flouroscopic guidance cervical medial branch radiofrequency ablation

Procedure

Electromagnetic wave deposition near nerve tissue for pain management

Primary outcomes

  1. neck disability index pre and post-intervention between comparison groups

    Time frame: 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.

  2. neck disability index pre and post-intervention between comparison groups

    Time frame: 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. neck disability index pre and post-intervention between comparison groups

    Time frame: 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.

  4. neck disability index pre and post-intervention between comparison groups

    Time frame: 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.

  5. VAS SCORE

    Time frame: One month

    of procedure, visual analog scale (VAS;1-100)

  6. VAS SCORE

    Time frame: 3 months

    of procedure, visual analog scale (VAS;1-100)

  7. VAS SCORE

    Time frame: 6 months

    of procedure, visual analog scale (VAS;1-100)

  8. VAS SCORE

    Time frame: 12 months

    of procedure, visual analog scale (VAS;1-100)

Secondary outcomes

  1. Duration of pain relief

    Time frame: 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

  2. Complications

    Time frame: One month, 3 months, 6months, 12 months

    Numbness, dysethesia, drop head syndrome, hypersensitivity, ataxia

Sponsors and collaborators

Lead sponsor

Fayoum University Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 9, 2023
Registry last updated
Feb 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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