InterventionD228NCT04594876
Cervical Epidural Versus Cevical Facet Injection for Patients With Chronic Cervical Pain
A study testing Flouroscopic guidance cervical epidural versus cervical facet injection in people with Intervention and Cervical, run by Fayoum University Hospital at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Intervention, Cervical, Epidural
- What is being tested?
- Flouroscopic guidance cervical epidural versus cervical facet injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2021to 20 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients age between 20 - 70 years old.
- ASA I and II
- Cervical pain at least 3 months before procedure
- Patients have failed pharmacological treatment.
Who cannot join
- Systemic infection
- Skin infection
- Bleeding tendency and coagulopathy
- Pregnancy
- Neurological disorders
- Any deformaties that disfacilate the procedure
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 .
- Conditions
- Intervention, Cervical, Epidural, Injection
- Being tested
- Flouroscopic guidance cervical epidural versus cervical facet injection
- Keywords
- Flouroscopy, Cervical epidural, Facet injection, Neck pain
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flouroscopic guidance cervical epidural versus cervical facet injectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Flouroscopic guidance Cervical Epidural injection | Other | Group (P) flouroscopic guidance cervical epidural injection Receives: Other: Flouroscopic guidance cervical epidural versus cervical facet injection |
| Flouroscopic guidance cervical facet injection | Other | Group (F) Flouroscopic guidance cervical facet injection Receives: Other: Flouroscopic guidance cervical epidural versus cervical facet injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: measured once within 1 day pre intervention
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.
Measured: 1 month, 3 month, 6 month,12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start1 Dec 2021
- Primary completion20 Dec 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group P will receive cervical epidural Group F will receive cervical facet injection Both under fluroscopic guidance
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atef Mohamed Sayed mahmoud, Fayoum University Hospital
- Investigators
- Atef Mahmoud, Principal investigator, Fayoum University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04594876
- Sponsor's protocol ID
- D228
- Other IDs
- D228
- Acronym
- D228
- Status last verified
- Oct 2023
- First submitted
- 7 Sep 2020
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study will be start after completion It will available
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Epidural Versus Cevical Facet Injection for Patients With Chronic Cervical Pain
- ClinicalTrials.gov ID
- NCT04594876
- Acronym / sponsor ID
- D228 / D228
- Conditions
- Intervention, Cervical, Epidural, Injection
- Keywords
- Flouroscopy, Cervical epidural, Facet injection, Neck pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Group P will receive cervical epidural Group F will receive cervical facet injection Both under fluroscopic guidance
| Arm | Type | Receives |
|---|---|---|
| Flouroscopic guidance Cervical Epidural injection | Other | Other: Flouroscopic guidance cervical epidural versus cervical facet injectionGroup (P) flouroscopic guidance cervical epidural injection |
| Flouroscopic guidance cervical facet injection | Other | Other: Flouroscopic guidance cervical epidural versus cervical facet injectionGroup (F) Flouroscopic guidance cervical facet injection |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients age between 20 - 70 years old.
- ASA I and II
- Cervical pain at least 3 months before procedure
- Patients have failed pharmacological treatment.
Key exclusion criteria (6 listed)
- Systemic infection
- Skin infection
- Bleeding tendency and coagulopathy
- Pregnancy
- Neurological disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flouroscopic guidance cervical epidural versus cervical facet injectionThe 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. | Other | Flouroscopic guidance Cervical Epidural injection, Flouroscopic guidance cervical facet injection |
Primary outcome
Neck pain disability index preintervention
Time frame: measured once within 1 day pre 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.
Change in Neck pain disability index post intervention
Time frame: 1 month, 3 month, 6 month,12 month
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Individual participant dataSharing planned: No. The study will be start after completion It will available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Atef Mahmoud principal investigator
Fayoum University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flouroscopic guidance cervical epidural versus cervical facet injection in people with Intervention and Cervical, run by Fayoum University Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck pain disability index preintervention (time frame: measured once within 1 day pre intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.