Clinical trial NCT04959721: Treatment for Whiplash Injury
Official title: The Effectiveness of Intra-articular Corticosteroid Injection in Patients With Whiplash-related Neck Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Facet Joint Pain
Keywords: Whiplash injury
Cervical facet joint
Chronic pain
Neck pain
Corticosteroid injection
Lead sponsor: Yeungnam University College of Medicine
Sponsor class: OTHER
First posted: 2021-07-13
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pain before intervention to be assessed with Numeric Rating Scale
timeFrame: The NRS score will be assessed the day before starting the intervention (pre-treatment).
measure: Pain after intervention to be assessed with Numeric Rating Scale
timeFrame: The NRS score will be assessed 1 month after the intervention
measure: Pain after intervention to be assessed with Numeric Rating Scale
timeFrame: The NRS score will be assessed 2 month after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
Study officials:
affiliation: Yuengnam University
name: Min Cheol Chang
role: STUDY_DIRECTOR
References:
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.
citation: Dory MA. Arthrography of the cervical facet joints. Radiology. 1983 Aug;148(2):379-82. doi: 10.1148/radiology.148.2.6867328.
citation: Dussault RG, Nicolet VM. Cervical facet joint arthrography. J Can Assoc Radiol. 1985 Mar;36(1):79-80.
citation: Hove B, Gyldensted C. Cervical analgesic facet joint arthrography. Neuroradiology. 1990;32(6):456-9. doi: 10.1007/BF02426454.
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.
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.