Treatment for Whiplash Injury

NCT ID: NCT04959721

Last Updated: 2021-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-15

Study Completion Date

2021-10-15

Brief Summary

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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

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Conditions

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Cervical Facet Joint Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Injection with triamcinolone acetonide, bupivacaine, and normal saline

Intervention Type COMBINATION_PRODUCT

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.

Interventions

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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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Min Cheol Chang

OTHER

Sponsor Role lead

Responsible Party

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Min Cheol Chang

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Min Cheol Chang

Role: STUDY_DIRECTOR

Yuengnam University

Locations

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Yeungnam University Hospital

Daegu, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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Min Cheol Chang

Role: CONTACT

+82-10-9362-1220

References

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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.

Reference Type BACKGROUND
PMID: 16439739 (View on PubMed)

Dory MA. Arthrography of the cervical facet joints. Radiology. 1983 Aug;148(2):379-82. doi: 10.1148/radiology.148.2.6867328.

Reference Type BACKGROUND
PMID: 6867328 (View on PubMed)

Dussault RG, Nicolet VM. Cervical facet joint arthrography. J Can Assoc Radiol. 1985 Mar;36(1):79-80.

Reference Type BACKGROUND
PMID: 3980558 (View on PubMed)

Hove B, Gyldensted C. Cervical analgesic facet joint arthrography. Neuroradiology. 1990;32(6):456-9. doi: 10.1007/BF02426454.

Reference Type BACKGROUND
PMID: 2287370 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28934800 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2967833 (View on PubMed)

Other Identifiers

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YUMC 2021-06-021

Identifier Type: -

Identifier Source: org_study_id

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