Treatment for Whiplash Injury

July 1, 2021 updated by: Min Cheol Chang

The Effectiveness of Intra-articular Corticosteroid Injection in Patients With Whiplash-related Neck Pain

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Injection group
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.
Combination product: Injection with triamcinolone acetonide, bupivacaine, and normal saline

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain before intervention to be assessed with Numeric Rating Scale
Time Frame: 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).
The NRS score will be assessed the day before starting the intervention (pre-treatment).
Pain after intervention to be assessed with Numeric Rating Scale
Time Frame: The NRS score will be assessed 1 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).
The NRS score will be assessed 1 month after the intervention
Pain after intervention to be assessed with Numeric Rating Scale
Time Frame: 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).
The NRS score will be assessed 2 month after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Min Cheol Chang

Investigators

  • Study Director: Min Cheol Chang, Yuengnam University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 15, 2021

Primary Completion (Anticipated)

September 15, 2021

Study Completion (Anticipated)

October 15, 2021

Study Registration Dates

First Submitted

June 21, 2021

First Submitted That Met QC Criteria

July 1, 2021

First Posted (Actual)

July 13, 2021

Study Record Updates

Last Update Posted (Actual)

July 13, 2021

Last Update Submitted That Met QC Criteria

July 1, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YUMC 2021-06-021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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