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
About this trial
This is an interventional supportive care trial for Intervention focused on measuring Flouroscopy, Cervical epidural, Facet injection, Neck pain
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
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
NCT ID
NCT04594876
First Posted
September 7, 2020
Last Updated
August 16, 2021
Sponsor
Fayoum University Hospital
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
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