Treatment for Whiplash Injury
Primary Purpose
Cervical Facet Joint Pain
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Injection with triamcinolone acetonide, bupivacaine, and normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Facet Joint Pain focused on measuring Whiplash injury, Cervical facet joint, Chronic pain, Neck pain, Corticosteroid injection
Eligibility Criteria
Inclusion Criteria:
- history of a traffic accident
- ≥ 3-month history of axial cervical pain after the accident without radicular symptoms
- whiplash-associated disorder (WAD) severity of Grade II (neck complaint, decreased range of motion of neck, and point tenderness) at first hospital visit
- failure to respond to physical therapy and oral medication (axial cervical pain of ≥ 3 on the numeric rating scale (NRS 0-10; 0, no pain; 10, worst pain imaginable)
- ≥ 80% temporary pain relief following a diagnostic block with an intra-articular (IA) injection of 0.3 mL of 2% lidocaine
Exclusion Criteria:
- presence of cervical spine fracture, coagulopathy, iodinated contrast allergy, rheumatic disorders, and any uncontrolled medical or psychiatric condition
Sites / Locations
- Yeungnam University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Injection group
Arm Description
Patients in the injection group will be injected 10 mg (0.25 mL) of triamcinolone acetonide, mixed with 0.25 mL of 0.125% bupivacaine and 0.5 mL of normal saline.
Outcomes
Primary Outcome Measures
Pain before intervention to be assessed with Numeric Rating Scale
The investigators will be assessed pain intensity using the NRS score as the primary outcome. Average pain intensity during the 24 hours before NRS assessment will be investigated. The Numeric Rating Scale (NRS) is the simplest and most commonly used numeric scale in which people rate the pain from 0 (no pain) to 10 (worst pain).
Pain after intervention to be assessed with Numeric Rating Scale
The investigators will be assessed pain intensity using the NRS score as the primary outcome. Average pain intensity during the 24 hours before NRS assessment will be investigated. The Numeric Rating Scale (NRS) is the simplest and most commonly used numeric scale in which people rate the pain from 0 (no pain) to 10 (worst pain).
Pain after intervention to be assessed with Numeric Rating Scale
The investigators will be assessed pain intensity using the NRS score as the primary outcome. Average pain intensity during the 24 hours before NRS assessment will be investigated. The Numeric Rating Scale (NRS) is the simplest and most commonly used numeric scale in which people rate the pain from 0 (no pain) to 10 (worst pain).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04959721
Brief Title
Treatment for Whiplash Injury
Official Title
The Effectiveness of Intra-articular Corticosteroid Injection in Patients With Whiplash-related Neck Pain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 15, 2021 (Anticipated)
Primary Completion Date
September 15, 2021 (Anticipated)
Study Completion Date
October 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Min Cheol Chang
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Objective: Cervical facet joint (CFJ) pain is commonly seen after whiplash injuries, and is frequently refractory to physical therapy and oral medication. The investigators will evaluate the effectiveness of intra-articular corticosteroid injection for managing whiplash-related CFJ pain.
Methods: The investigators will recruit 32 patients with chronic and persistent CFJ pain (≥ 3 on the Numeric Rating Scale [NRS]) despite physical therapy and oral medication. Under fluoroscopy guidance, The investigators will inject 10 mg (0.25 mL) of triamcinolone acetonide, mixed with 0.25 mL of 0.125% bupivacaine and 0.5 mL of normal saline. At 1 and 2 months after the injection, pain intensity will be reassessed using the NRS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Facet Joint Pain
Keywords
Whiplash injury, Cervical facet joint, Chronic pain, Neck pain, Corticosteroid injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Injection group
Arm Type
Experimental
Arm Description
Patients in the injection group will be injected 10 mg (0.25 mL) of triamcinolone acetonide, mixed with 0.25 mL of 0.125% bupivacaine and 0.5 mL of normal saline.
Intervention Type
Combination Product
Intervention Name(s)
Injection with triamcinolone acetonide, bupivacaine, and normal saline
Intervention Description
Triamcinolone acetonide is a synthetic corticosteroid medication used intra-articularly to treat various joint conditions. Bupivacaine is a medication used to decrease feeling in a specific area. In nerve blocks, it is injected around a nerve that supplies the area, or into the spinal canal's epidural space. Saline is most commonly used as a sterile 9 g of salt per litre (0.9%) solution, known as normal saline.
The procedure will be performed with the patient in a prone position under a C-arm fluoroscopy scanner, with the thorax rests on 2 pillows, flexing the neck maximally, and the head turns 60-90° away from the side of injection. The C-arm tube will be angled cephalad, until it was at a tangent to the cervical facet joint space. A 26-gauge, 90 mm spinal needle will be inserted parallel to the C-arm beam. To confirm intra-articular placement of the needle tip, an arthrogram of the cervical facet joint will be performed by injecting 0.3 mL of contrast.
Primary Outcome Measure Information:
Title
Pain before intervention to be assessed with Numeric Rating Scale
Description
The investigators will be assessed pain intensity using the NRS score as the primary outcome. Average pain intensity during the 24 hours before NRS assessment will be investigated. The Numeric Rating Scale (NRS) is the simplest and most commonly used numeric scale in which people rate the pain from 0 (no pain) to 10 (worst pain).
Time Frame
The NRS score will be assessed the day before starting the intervention (pre-treatment).
Title
Pain after intervention to be assessed with Numeric Rating Scale
Description
The investigators will be assessed pain intensity using the NRS score as the primary outcome. Average pain intensity during the 24 hours before NRS assessment will be investigated. The Numeric Rating Scale (NRS) is the simplest and most commonly used numeric scale in which people rate the pain from 0 (no pain) to 10 (worst pain).
Time Frame
The NRS score will be assessed 1 month after the intervention
Title
Pain after intervention to be assessed with Numeric Rating Scale
Description
The investigators will be assessed pain intensity using the NRS score as the primary outcome. Average pain intensity during the 24 hours before NRS assessment will be investigated. The Numeric Rating Scale (NRS) is the simplest and most commonly used numeric scale in which people rate the pain from 0 (no pain) to 10 (worst pain).
Time Frame
The NRS score will be assessed 2 month after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
history of a traffic accident
≥ 3-month history of axial cervical pain after the accident without radicular symptoms
whiplash-associated disorder (WAD) severity of Grade II (neck complaint, decreased range of motion of neck, and point tenderness) at first hospital visit
failure to respond to physical therapy and oral medication (axial cervical pain of ≥ 3 on the numeric rating scale (NRS 0-10; 0, no pain; 10, worst pain imaginable)
≥ 80% temporary pain relief following a diagnostic block with an intra-articular (IA) injection of 0.3 mL of 2% lidocaine
Exclusion Criteria:
presence of cervical spine fracture, coagulopathy, iodinated contrast allergy, rheumatic disorders, and any uncontrolled medical or psychiatric condition
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Cheol Chang
Phone
+82-10-9362-1220
Email
wheel633@ynu.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Cheol Chang
Organizational Affiliation
Yuengnam University
Official's Role
Study Director
Facility Information:
Facility Name
Yeungnam University Hospital
City
Daegu
ZIP/Postal Code
705-717
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Participants' personal information will be stored for 3 years and then destroyed in accordance with relevant regulations. Personal information of individuals is kept strictly confidential and cannot be used for other research without personal consent.
Citations:
PubMed Identifier
16439739
Citation
Crouch R, Whitewick R, Clancy M, Wright P, Thomas P. Whiplash associated disorder: incidence and natural history over the first month for patients presenting to a UK emergency department. Emerg Med J. 2006 Feb;23(2):114-8. doi: 10.1136/emj.2004.022145.
Results Reference
background
PubMed Identifier
6867328
Citation
Dory MA. Arthrography of the cervical facet joints. Radiology. 1983 Aug;148(2):379-82. doi: 10.1148/radiology.148.2.6867328.
Results Reference
background
PubMed Identifier
3980558
Citation
Dussault RG, Nicolet VM. Cervical facet joint arthrography. J Can Assoc Radiol. 1985 Mar;36(1):79-80.
Results Reference
background
PubMed Identifier
2287370
Citation
Hove B, Gyldensted C. Cervical analgesic facet joint arthrography. Neuroradiology. 1990;32(6):456-9. doi: 10.1007/BF02426454.
Results Reference
background
PubMed Identifier
28934800
Citation
Lim JW, Cho YW, Lee DG, Chang MC. Comparison of Intraarticular Pulsed Radiofrequency and Intraarticular Corticosteroid Injection for Management of Cervical Facet Joint Pain. Pain Physician. 2017 Sep;20(6):E961-E967.
Results Reference
background
PubMed Identifier
2967833
Citation
Roy DF, Fleury J, Fontaine SB, Dussault RG. Clinical evaluation of cervical facet joint infiltration. Can Assoc Radiol J. 1988 Jun;39(2):118-20.
Results Reference
background
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Treatment for Whiplash Injury
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