search
Back to results

Cervical Epidural Versus Cevical Facet Injection for Patients With Chronic Cervical Pain (D228)

Primary Purpose

Intervention, Cervical, Epidural

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Flouroscopic guidance cervical epidural versus cervical facet injection
Sponsored by
Fayoum University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Intervention focused on measuring Flouroscopy, Cervical epidural, Facet injection, Neck pain

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients age between 20 - 70 years old.
  • ASA I and II
  • Cervical pain at least 3 months before procedure
  • Patients have failed pharmacological treatment.

Exclusion Criteria:

  • Systemic infection
  • Skin infection
  • Bleeding tendency and coagulopathy
  • Pregnancy
  • Neurological disorders
  • Any deformaties that disfacilate the procedure

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Flouroscopic guidance Cervical Epidural injection

    Flouroscopic guidance cervical facet injection

    Arm Description

    Group (P) flouroscopic guidance cervical epidural injection

    Group (F) Flouroscopic guidance cervical facet injection

    Outcomes

    Primary Outcome Measures

    Neck pain disability index preintervention
    The NDI has become a standard instrument for measuring self-rated disability due to neck pain and is used by clinicians and researchers alike. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score. Occasionally, a respondent will not complete one question or another. The average of all other items is then added to the completed items. The original report provided scoring intervals for interpretation, as follows: 0 - 4 = no disability 5 - 14 = mild 15 - 24 = moderate 25 - 34 = severe above 34 = complete.
    Change in Neck pain disability index post intervention
    The NDI has become a standard instrument for measuring self-rated disability due to neck pain and is used by clinicians and researchers alike. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score. Occasionally, a respondent will not complete one question or another. The average of all other items is then added to the completed items. The original report provided scoring intervals for interpretation, as follows: 0 - 4 = no disability 5 - 14 = mild 15 - 24 = moderate 25 - 34 = severe above 34 = complete.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 7, 2020
    Last Updated
    August 16, 2021
    Sponsor
    Fayoum University Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04594876
    Brief Title
    Cervical Epidural Versus Cevical Facet Injection for Patients With Chronic Cervical Pain
    Acronym
    D228
    Official Title
    Cervical Epidural Versus Cevical Facet Injection for Patients With Chronic Cervical Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 1, 2021 (Anticipated)
    Primary Completion Date
    December 5, 2022 (Anticipated)
    Study Completion Date
    December 20, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fayoum University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    After approval of the institutional review board and the Ethics Committee of Al Fayoum University number (D228) , and written informed consent from all patientṣ Pilot study will be done to confirm this sample size .The patients are classified in two groups group P for cervical epidural and group F for facet injection To compare effectivness of cervical epidural versus cervical facet injection under fluroscopic guidance in patients sufferring from chronic neck pain.
    Detailed Description
    After the approval of the institutional review board and the Ethics Committee of Al Fayoum University number (D228) , and written informed consent from all patientṣ Pilot study will be done to confirm this sample size .The patients are classified in two groups group P for cervical epidural and group F for facet injection. Patients Inclusion criteria of chronic cervical pain syndromes will be made from their history, symptoms, and imaging diagnosis. Patients will be lying down on the prone position. In group( F) Under the C-arm fluoroscopic guidance targeted zygapophyseal joints will be identified. The mixture of 2 mL of 2% lidocaine with 2 ml of beta methasone (6 mg/ml) will be injected in the joints unilaterally or bilaterally according to complaints of patients. Another group ( P) patients will undergo translaminar or interspinous cervical epidural block (CEBs). The translaminar or interlaminar approach is considered the safest and most effective technique for cervical epidural placement.The patient will be in a prone position. This procedure will be performed with fluoroscopic guidance. The patient will be placed in an optimal flexed cervical spine posture stabilized with enough resistance to prevent movement of the head during the procedure. The skin will be prepared with an antiseptic solution. The midline of the selected interspace will be identified under fluroscopic guidance. LA, such as lidocaine, will be used, to mark the intended site of skin entry. As much as 1 mL of lidocaine will be used to infiltrate the skin and subcutaneous tissues. We will insert a 25-gauge, 2-inch needle exactly into the targeted midline. After the LA has been given time to anesthetize the area,we will hold the needle firmly at the hub with the left thumb and index finger. Then the palm of the left hand will be placed firmly against the patient's neck, so that the left hand acts as a unit to stabilize, protect, and control the needle's trajectory and its metered ingress from any unexpected patient activity. The needle will be then advanced with the left hand, which is braced against the neck with the needle hub held tightly between the left thumb and forefinger. We will use the right hand to monitor resistance through a syringe containing air. With constant pressure applied to the plunger of the syringe through light pressure applied by the right thumb, the needle and syringe will be advanced in a slow and deliberate manner. As the bevel passes through the ligament flavum and enters the epidural space, a sudden loss of resistance that we will appreciate also we can appreciate the entrence the epidural space under fluroscopic guidance in condition that not to cross J line (a line appear under flouroscopy imaging facet joint articulation if crossing this line we will puncture the dura). Needle position within the epidural space will be checked by using fluoroscopic verification and by repeating the loss of resistance maneuver. The cervical epidural space should accept 0.5-1 mL of air or sterile preservative free saline without significant resistance. The force required to depress the plunger should not exceed that which is necessary to overcome the resistance of the needle. Any significant pain or sudden increase in resistance during the injection suggests incorrect needle placement, so the injection will be stopped and we will assess the position of the needle using fluoroscopy. If the needle remains satisfactorily placed and loss of resistance within the epidural space is confirmed without additional patient report of pain, gentle aspiration will be checked to assure that the needle is not positioned in the subarachnoid space or that it's not intravascular. If cerebrospinal fluid (CSF) is aspirated, we will repeat the block attempt at a different interspace. If aspiration of blood occurs, the needle will be tightly rotated and the aspiration test will be repeated. If the aspiration of blood continues, the procedure will be aborted due to the danger of developing an epidural hematoma and possibly neurological compromise. when the needle is correctly placed in the midline of the epidural space, then injection of the mixture of 2 mL of 2% lidocaine with 2 ml of beta methasone (6 mg/ml) will be done .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intervention, Cervical, Epidural, Injection
    Keywords
    Flouroscopy, Cervical epidural, Facet injection, Neck pain

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Group P will receive cervical epidural Group F will receive cervical facet injection Both under fluroscopic guidance
    Masking
    Investigator
    Masking Description
    The patients were randomly allocated by a computer-generated table into one of two study groups. The randomization sequence was concealed in opaque sealed envelopes. The envelopes were opened by the study investigators just after recruitments and admission to the operation room. Only assessors and data collectors were blinded to the group's allocations
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Flouroscopic guidance Cervical Epidural injection
    Arm Type
    Other
    Arm Description
    Group (P) flouroscopic guidance cervical epidural injection
    Arm Title
    Flouroscopic guidance cervical facet injection
    Arm Type
    Other
    Arm Description
    Group (F) Flouroscopic guidance cervical facet injection
    Intervention Type
    Other
    Intervention Name(s)
    Flouroscopic guidance cervical epidural versus cervical facet injection
    Intervention Description
    The patients are classified in two groups group P for cervical epidural and group F for facet injection. The skin will be prepared with an antiseptic solution. The midline of the selected interspace will be identified under fluroscopic guidance.
    Primary Outcome Measure Information:
    Title
    Neck pain disability index preintervention
    Description
    The NDI has become a standard instrument for measuring self-rated disability due to neck pain and is used by clinicians and researchers alike. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score. Occasionally, a respondent will not complete one question or another. The average of all other items is then added to the completed items. The original report provided scoring intervals for interpretation, as follows: 0 - 4 = no disability 5 - 14 = mild 15 - 24 = moderate 25 - 34 = severe above 34 = complete.
    Time Frame
    measured once within 1 day pre intervention
    Title
    Change in Neck pain disability index post intervention
    Description
    The NDI has become a standard instrument for measuring self-rated disability due to neck pain and is used by clinicians and researchers alike. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score. Occasionally, a respondent will not complete one question or another. The average of all other items is then added to the completed items. The original report provided scoring intervals for interpretation, as follows: 0 - 4 = no disability 5 - 14 = mild 15 - 24 = moderate 25 - 34 = severe above 34 = complete.
    Time Frame
    1 month, 3 month, 6 month,12 month
    Other Pre-specified Outcome Measures:
    Title
    Total opoid and non steroidal consumption preintervention
    Description
    Pre intervention total dose of opoid and an non steroid consumption
    Time Frame
    measured once 1 day preintervention
    Title
    Total opoid and non steroidal consumption post intervention
    Description
    Total dose intake of opoid and non steroid consumption post intervention
    Time Frame
    measured (1 month,3 month,6 month,12 month)"post intervention
    Title
    VAS Score
    Description
    Graded frome 0 no pain to 10 maximum pain
    Time Frame
    0 hour, 2 hours, 4 hours, 6hours, 12 hours, 18 hours, 24 hours post operative
    Title
    Post operative Nausea & vomiting score
    Description
    From grade 0 no nausea or vomiting to grade 4 sever vomitting
    Time Frame
    0 hour,2 hours,4 hours,6 hours,12 hours,18 hours,24 hours post operative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients age between 20 - 70 years old. ASA I and II Cervical pain at least 3 months before procedure Patients have failed pharmacological treatment. Exclusion Criteria: Systemic infection Skin infection Bleeding tendency and coagulopathy Pregnancy Neurological disorders Any deformaties that disfacilate the procedure
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Atef Mahmoud
    Phone
    01003973883
    Email
    dr.atef.khalil@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Atef Mahmoud
    Organizational Affiliation
    Fayoum University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    The study will be start after completion It will available

    Learn more about this trial

    Cervical Epidural Versus Cevical Facet Injection for Patients With Chronic Cervical Pain

    We'll reach out to this number within 24 hrs