NCT04640896 Trigger Point Injections in Anterior Cervical Surgery
| NCT ID | NCT04640896 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | George Washington University |
| Condition | Myofacial Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2020-11-05 |
| Primary Completion | 2023-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2020-11-05 with a primary completion date of 2023-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To achieve appropriate exposure for an anterior neck surgery (for example an Anterior Cervical Discectomy and Fusion or ACDF), patients are positioned supine with their neck extended. Due to being in this position, patients frequently complain of posterior neck stiffness and pain postoperatively in addition to the anterior incisional pain. This posterior cervical pain can be classified as myofascial pain. Cervical myofascial pain is thought to be the result of overuse or trauma to the supporting muscles of the neck and shoulders. Trigger point injections are one of the methods used to treat myofascial pain. The trigger point injection procedure is where a physician (typically an anesthesiologist) performs an exam of the patient neck and upper back and finds areas of point tenderness. The physician will then inject a small amount of numbing medication (such as bupivacaine) into the muscle or tissue in that area. Trigger point injections have been shown to be superior to botox injections or dry needling, and equivalent to physical therapy. However, these studies were performed on patients with chronic neck pain. There are no studies evaluating the effectiveness of trigger point injections on post anterior cervical surgery patients. At our institution, trigger point injections with local anesthetic are used as part of a multimodal pain control regimen for post-anterior cervical surgery patients. Our hypothesis is if the addition of trigger point injections to standard of care multi-modal post-operative pain control will decrease patients' myofascial pain, and thereby decrease the amount of narcotic pain medication used.
Eligibility Criteria
Inclusion Criteria: * Elective anterior cervical surgery Exclusion Criteria: * Emergency surgery * Local anesthetic allergy * Long term opioid usage (not including tramadol and codeine) * Intra-operative complication (e.g. unstable cervical spine)
Frequently Asked Questions
Who can join the NCT04640896 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myofacial Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04640896 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04640896 currently recruiting?
Yes, NCT04640896 is actively recruiting participants. Visit ClinicalTrials.gov or contact George Washington University to inquire about joining.
Where is the NCT04640896 trial being conducted?
This trial is being conducted at Washington D.C., United States.
Who is sponsoring the NCT04640896 clinical trial?
NCT04640896 is sponsored by George Washington University. The trial plans to enroll 60 participants.