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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Egypt1 site
  • Atef Mohamed mahmoud

    Al Fayyum, 63512

Other trials in Egypt

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 .

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 groups in NCT04594876
Study groupRoleWhat they receive
Flouroscopic guidance Cervical Epidural injectionOtherGroup (P) flouroscopic guidance cervical epidural injection
Receives: Other: Flouroscopic guidance cervical epidural versus cervical facet injection
Flouroscopic guidance cervical facet injectionOtherGroup (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.

  1. 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

  2. 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.

  1. First posted20 Oct 2020
  2. Study start1 Dec 2021
  3. Primary completion20 Dec 2022
  4. Study completion20 Dec 2022

Resources

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)
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

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.

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