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

NCT04594876 | Completed DMC

• 1 other identifier: D228
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Intervention; Cervical; Epidural; Injection

Keywords

Flouroscopy; Cervical epidural; Facet injection; Neck pain

Outcome Measures

Primary Outcomes (2)

• 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 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.

  1 month, 3 month, 6 month,12 month

Other Outcomes (4)

• Total opoid and non steroidal consumption preintervention

  measured once 1 day preintervention

• Total opoid and non steroidal consumption post intervention

  measured (1 month,3 month,6 month,12 month)"post intervention

• VAS Score

  0 hour, 2 hours, 4 hours, 6hours, 12 hours, 18 hours, 24 hours post operative

Study Arms (2)

Flouroscopic guidance Cervical Epidural injection

OTHER

Group (P) flouroscopic guidance cervical epidural injection

Other: Flouroscopic guidance cervical epidural versus cervical facet injection

Flouroscopic guidance cervical facet injection

OTHER

Group (F) Flouroscopic guidance cervical facet injection

Other: Flouroscopic guidance cervical epidural versus cervical facet injection

Interventions

Flouroscopic guidance cervical epidural versus cervical facet injection OTHER

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.

Flouroscopic guidance Cervical Epidural injection; Flouroscopic guidance cervical facet injection

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Atef Mohamed mahmoud

Al Fayyum, 63512, Egypt

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Atef Mahmoud

  Fayoum University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Group P will receive cervical epidural Group F will receive cervical facet injection Both under fluroscopic guidance

Study Record Dates

• First Submitted: September 7, 2020
• First Posted: October 20, 2020
• Study Start: December 1, 2021
• Primary Completion: December 20, 2022
• Study Completion: December 20, 2022
• Last Updated: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)