An interventional study of Injection with triamcinolone acetonide, bupivacaine, and normal saline in Cervical Facet Joint Pain, sponsored by Min Cheol Chang. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years to 79 Years. Per ClinicalTrials.gov, last updated 2021-07-13.
Sponsored by Min Cheol Chang · Not applicable, Interventional, and Treatment
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.
273 studies on the registry are indexed under Arthralgia; 41 are open to participants now.
This study's planned enrollment of 32 is below the median of 63 across 219 interventional studies indexed under Arthralgia.
Browse Arthralgia studies →Min Cheol Chang is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
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).
Time frame: 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).
Time frame: 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).
Time frame: The NRS score will be assessed 2 month after the intervention
Plan to share: 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.
This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Min Cheol Chang