Cervical Facet Joint PainNCT04959721
Treatment for Whiplash Injury
A study testing Injection with triamcinolone acetonide, bupivacaine, and normal saline in people with Cervical Facet Joint Pain, run by Min Cheol Chang at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Cervical Facet Joint Pain
- What is being tested?
- Injection with triamcinolone acetonide, bupivacaine, and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Jul 2021to 15 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- presence of cervical spine fracture, coagulopathy, iodinated contrast allergy, rheumatic disorders, and any uncontrolled medical or psychiatric condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cervical Facet Joint Pain
- Being tested
- Injection with triamcinolone acetonide, bupivacaine, and normal saline
- Keywords
- Whiplash injury, Cervical facet joint, Chronic pain, Neck pain, Corticosteroid injection
- Medical subject headings
- Whiplash Injuries, Chronic Pain, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection with triamcinolone acetonide, bupivacaine, and normal salineCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| Injection group | Experimental | 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. Receives: Combination Product: Injection with triamcinolone acetonide, bupivacaine, and normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: The NRS score will be assessed the day before starting the intervention (pre-treatment).
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).
Measured: The NRS score will be assessed 1 month after the intervention
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).
Measured: The NRS score will be assessed 2 month after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start15 Jul 2021 (estimated)
- Primary completion15 Sep 2021 (estimated)
- Study completion15 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cervical Facet Joint PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Min Cheol Chang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Min Cheol Chang, Yeungnam University College of Medicine
- Investigators
- Min Cheol Chang, Study director, Yuengnam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04959721
- Sponsor's protocol ID
- YUMC 2021-06-021
- Status last verified
- Jul 2021
- First submitted
- 21 Jun 2021
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 16439739Dory MA. Arthrography of the cervical facet joints. Radiology. 1983 Aug;148(2):379-82. doi: 10.1148/radiology.148.2.6867328.
PubMed 6867328Dussault RG, Nicolet VM. Cervical facet joint arthrography. J Can Assoc Radiol. 1985 Mar;36(1):79-80.
PubMed 3980558Hove B, Gyldensted C. Cervical analgesic facet joint arthrography. Neuroradiology. 1990;32(6):456-9. doi: 10.1007/BF02426454.
PubMed 2287370Lim 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.
PubMed 28934800Roy DF, Fleury J, Fontaine SB, Dussault RG. Clinical evaluation of cervical facet joint infiltration. Can Assoc Radiol J. 1988 Jun;39(2):118-20.
PubMed 2967833
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Intra-articular Corticosteroid Injection in Patients With Whiplash-related Neck Pain
- ClinicalTrials.gov ID
- NCT04959721
- Acronym / sponsor ID
- YUMC 2021-06-021
- Conditions
- Cervical Facet Joint Pain
- Keywords
- Whiplash injury, Cervical facet joint, Chronic pain, Neck pain, Corticosteroid injection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Min Cheol ChangUniversity, hospital or other
- Study start
- 15 Jul 2021 (estimated)
- Primary completion
- 15 Sep 2021 (estimated)
- Study completion
- 15 Oct 2021 (estimated)
- First posted
- 13 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Injection group | Experimental | Combination Product: Injection with triamcinolone acetonide, bupivacaine, and normal salinePatients 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. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- presence of cervical spine fracture, coagulopathy, iodinated contrast allergy, rheumatic disorders, and any uncontrolled medical or psychiatric condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injection with triamcinolone acetonide, bupivacaine, and normal salineTriamcinolone 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. | Combination product | Injection group |
Primary outcome
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).
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).
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- Background: PubMed 16439739Crouch 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.
- Background: PubMed 6867328Dory MA. Arthrography of the cervical facet joints. Radiology. 1983 Aug;148(2):379-82. doi: 10.1148/radiology.148.2.6867328.
- Background: PubMed 3980558Dussault RG, Nicolet VM. Cervical facet joint arthrography. J Can Assoc Radiol. 1985 Mar;36(1):79-80.
- Background: PubMed 2287370Hove B, Gyldensted C. Cervical analgesic facet joint arthrography. Neuroradiology. 1990;32(6):456-9. doi: 10.1007/BF02426454.
- Background: PubMed 28934800Lim 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.
- Background: PubMed 2967833Roy DF, Fleury J, Fontaine SB, Dussault RG. Clinical evaluation of cervical facet joint infiltration. Can Assoc Radiol J. 1988 Jun;39(2):118-20.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Cheol Chang study director
Yuengnam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injection with triamcinolone acetonide, bupivacaine, and normal saline in people with Cervical Facet Joint Pain, run by Min Cheol Chang at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Cheol Chang (+82-10-9362-1220, wheel633@ynu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04959721, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2021.