Treatment for Whiplash Injury

Not Applicable

• Conditions: Cervical Facet Joint Pain
• Interventions: Combination Product: Injection with triamcinolone acetonide, bupivacaine, and normal saline

• Registration Number: NCT04959721
• Lead Sponsor: Min Cheol Chang

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-21
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-01
• Last Update Submitted: 2021-07-01
• Study First Posted: 2021-07-13
• Last Update Posted: 2021-07-13
• Study Start: 2021-07-15
• Primary Completion: 2021-09-15
• Study Completion: 2021-10-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Injection group	Injection with triamcinolone acetonide, bupivacaine, and normal saline	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.

Primary Outcome Measures

Name	Time	Method
Pain after intervention to be assessed with Numeric Rating Scale	The NRS score will be assessed 2 month after the intervention	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 before intervention to be assessed with Numeric Rating Scale	The NRS score will be assessed the day before starting the intervention (pre-treatment).	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).

Trial Locations

Locations (1)

Yeungnam University Hospital; 🇰🇷 Daegu, Korea, Republic of