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Comparison Between Retrolaminar and Medial Branch Block in Cervical Facet Joint Arthropathy

Primary Purpose

Joint Pain

Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Retrolaminar block
Medial Branch Block
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Joint Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients more than 18 years old of both genders with cervical facet joint arthropathy confirmed by magnetic resonance imaging (MRI) and neck manual examination and not responding to conservative treatments
  • numeric rating scale (NRS) ≥ 4 that ranged from 0 (no pain) to 10 (extreme pain).,
  • American society of Anesthesiology Physical Status class I and II,
  • Body mass index ˂ 30

Exclusion Criteria:

  • The exclusion criteria are patient refusal
  • local or systemic sepsis, coagulopathy,
  • unstable cardiovascular and respiratory diseases,
  • previous neurological deficits,
  • history of psychiatric disorders,
  • history of drug abuse,
  • distorted local anatomy,
  • those who were allergic to the used medications .

Sites / Locations

  • Yahya WahbaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group medial branch block

Group retrolaminar block

Arm Description

cervical medial branch block will done at the affected dermatomal level using 1 mL of a mixture of 0.5 mL 1% lidocaine and 0.5 mL dexamethasome (8mg/2ml).

cervical retrolaminar block was done using 5 mL of a mixture of 3 mL 1% lidocaine and 2 mL dexamethasome (8mg/2ml) for each affected dermatomal level.

Outcomes

Primary Outcome Measures

Numerical rating score
from zero to 10 (where 0 no pain, 10 the worst pain)
Numerical rating score
from zero to 10 (where 0 no pain, 10 the worst pain)
Numerical rating score
from zero to 10 (where 0 no pain, 10 the worst pain)
Numerical rating score
from zero to 10 (where 0 no pain, 10 the worst pain)

Secondary Outcome Measures

Neck disability index
Each of the 10 items scores from 0 to 5. The maximum score is 50. 0 to 4 = no disability, 5 to 14 = mild, 15 to 24 = moderate, 25 to 34 = severe and above 34 = complete.
Neck disability index
Each of the 10 items scores from 0 to 5. The maximum score is 50. 0 to 4 = no disability, 5 to 14 = mild, 15 to 24 = moderate, 25 to 34 = severe and above 34 = complete.

Full Information

First Posted
December 22, 2021
Last Updated
August 13, 2022
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT05184881
Brief Title
Comparison Between Retrolaminar and Medial Branch Block in Cervical Facet Joint Arthropathy
Official Title
Comparison Between Retrolaminar and Medial Branch Block in Cervical Facet Joint Arthropathy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
August 30, 2022 (Anticipated)
Study Completion Date
October 30, 2022 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Cervical facet joints have been implicated as a source of chronic pain in 54-67 % patients with chronic posterior neck pain.1 Intraarticular injections, medial branch nerve blocks and neurolysis of medial branch nerves have been described in managing chronic neck pain of facet joint origin.2 The evidence for long-term therapeutic benefits of intraarticular injections of facet joints is limited. Medial branch nerve blocks show moderate evidence of long-term benefit with evidence of side effects.3 Paraneuraxial nerve blocks have become very popular clinically, due to their clinical and anatomical characteristics. These techniques are comparable to neuraxial nerve blocks in terms of success rate and analgesic efficacy and may confer many of advantages over neuraxial nerve blocks.4 Retrolaminar blocks are among this family that are near but not within the neuraxis like spinals or epidurals.5 Most reports and studies of retrolaminar blocks have been in the context of anesthesia for truncal surgery and truncal pain syndromes (thoracic and abdominal).6 Postoperative and pain treatment cervical retrolaminar blocks studies are currently sparse.7 The major advantage of this technique is minimizing or even eliminating the risk of pneumothorax. Additionally, the risks of nerve root damage and inadvertent injection into a dural sleeve, an intervertebral foramen, or the epidural or intrathecal spaces should also be decreased.8
Detailed Description
This prospective randomized open comparative study will be conducted in pain clinic, Mansoura University Hospitals. The study will be approved by the Ethics Research Committee of the Faculty of Medicine, Mansoura University and will be carried out in compliance with the Helsinki Declaration. Informed written consent will be signed from every patient participating in this study after full description of all details of every aspect in this study. The study participants were randomly grouped on a scale of 1:1, using a computer-generated list of random numbers. The distribution results were sealed in an opaque envelope and kept by the study administrator. On the day of block, the study manager handed the envelope to the anesthesiologist who will perform the block. Grouping: Group M: cervical medial branch block will done at the affected dermatomal level using 1 mL of a mixture of 0.5 mL 1% lidocaine and 0.5 mL dexamethasome (8mg/2ml). Group R: cervical retrolaminar block was done using 5 mL of a mixture of 3 mL 1% lidocaine and 2 mL dexamethasome (8mg/2ml) for each affected dermatomal level.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Joint Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group medial branch block
Arm Type
Active Comparator
Arm Description
cervical medial branch block will done at the affected dermatomal level using 1 mL of a mixture of 0.5 mL 1% lidocaine and 0.5 mL dexamethasome (8mg/2ml).
Arm Title
Group retrolaminar block
Arm Type
Active Comparator
Arm Description
cervical retrolaminar block was done using 5 mL of a mixture of 3 mL 1% lidocaine and 2 mL dexamethasome (8mg/2ml) for each affected dermatomal level.
Intervention Type
Other
Intervention Name(s)
Retrolaminar block
Intervention Description
2- Cervical retrolaminar block: will be performed on prone-positioned patients. Under fluoroscopic visualization, after identification of the lamina at the desired level, a 25-gauge, 3.5-inch spinal needle was introduced and when the needle tip will be confirmed at the posterior aspect of the cervical lamina corresponding to cervical facet arthropathy level. 5 mL of a mixture of 3 mL 1% lidocaine and 2 mL dexamethasome (8mg/2ml) will be injected.
Intervention Type
Other
Intervention Name(s)
Medial Branch Block
Intervention Description
1- Cervical medial branch block: will be performed on prone-positioned patients using a posterior approach. Under fluoroscopic visualization, after identification of the waists of the articular pillars at the desired levels, each medial branch block was administered with a 25-gauge, 3.5-inch spinal needle. When the place of the needle tip will be confirmed at the mid-point of the waists of articular pillars, 1 ml of the mixture of 0.5 mL 1% lidocaine and 0.5 mL dexamethasome (8mg/2ml) will be injected at each level.
Primary Outcome Measure Information:
Title
Numerical rating score
Description
from zero to 10 (where 0 no pain, 10 the worst pain)
Time Frame
before injection
Title
Numerical rating score
Description
from zero to 10 (where 0 no pain, 10 the worst pain)
Time Frame
after 2 weeks from injection
Title
Numerical rating score
Description
from zero to 10 (where 0 no pain, 10 the worst pain)
Time Frame
after 2 month from block
Title
Numerical rating score
Description
from zero to 10 (where 0 no pain, 10 the worst pain)
Time Frame
after 3 month from block
Secondary Outcome Measure Information:
Title
Neck disability index
Description
Each of the 10 items scores from 0 to 5. The maximum score is 50. 0 to 4 = no disability, 5 to 14 = mild, 15 to 24 = moderate, 25 to 34 = severe and above 34 = complete.
Time Frame
before injection
Title
Neck disability index
Description
Each of the 10 items scores from 0 to 5. The maximum score is 50. 0 to 4 = no disability, 5 to 14 = mild, 15 to 24 = moderate, 25 to 34 = severe and above 34 = complete.
Time Frame
after 2 weeks from injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients more than 18 years old of both genders with cervical facet joint arthropathy confirmed by magnetic resonance imaging (MRI) and neck manual examination and not responding to conservative treatments numeric rating scale (NRS) ≥ 4 that ranged from 0 (no pain) to 10 (extreme pain)., American society of Anesthesiology Physical Status class I and II, Body mass index ˂ 30 Exclusion Criteria: The exclusion criteria are patient refusal local or systemic sepsis, coagulopathy, unstable cardiovascular and respiratory diseases, previous neurological deficits, history of psychiatric disorders, history of drug abuse, distorted local anatomy, those who were allergic to the used medications .
Facility Information:
Facility Name
Yahya Wahba
City
Mansoura
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yahya m wahba, assist prof.
Phone
01211313554
Email
yahyawahba@gmail.com
First Name & Middle Initial & Last Name & Degree
adel abdel ghaffar, pof.
Phone
01210101001
Email
adelghaffar49@gmail.com
First Name & Middle Initial & Last Name & Degree
Basem I Awad, assist prof

12. IPD Sharing Statement

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Comparison Between Retrolaminar and Medial Branch Block in Cervical Facet Joint Arthropathy

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