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NCT04640896 · ClinicalTrials.gov registry record · Phase 4
Trigger Point Injections in Anterior Cervical Surgery
A Phase 4 study of Pain, Back and Myofacial Pain, sponsored by George Washington University.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT04640896 is a Phase 4 study of Pain, Back and Myofacial Pain that is actively recruiting participants, run by George Washington University. The registered enrollment target is 60 participants, below the 324-participant average among 7 other Pain, Back trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04640896, a Phase 4 study of Pain, Back and Myofacial Pain, is actively recruiting participants, sponsored by George Washington University.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Trigger point injection with bupivacaine
- DRUG Trigger point injection with normal saline
- DRUG Lidocaine skin wheal
Study Locations (1)
District of Columbia
- George Washington University Hospital - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2020-11-05 |
| Est. Completion | 2023-12-31 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04640896
The ClinicalTrials.gov registry entry for NCT04640896 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 324-participant average among 7 other Pain, Back trials with a reported enrollment target (81% lower). The listed sponsor is George Washington University, which has 133 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Pain, Back appearing as the primary indexed condition, and to 3 interventions - of which Trigger point injection with bupivacaine is the first listed.
NCT04640896 reports 1 study location spanning 1 distinct geographic area - top geographies include District of Columbia.
Frequently Asked Questions
What is clinical trial NCT04640896 about?
NCT04640896 is a clinical study titled "Trigger Point Injections in Anterior Cervical Surgery". 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 ...
What is the current status of trial NCT04640896?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2020-11-05. Estimated completion is 2023-12-31.
What conditions does trial NCT04640896 study?
This clinical trial studies the following conditions: Pain, Back, Myofacial Pain, Cervical Fusion, Pain, Neck.
What interventions are being tested in trial NCT04640896?
The interventions under investigation include: Trigger point injection with bupivacaine (DRUG), Trigger point injection with normal saline (DRUG), Lidocaine skin wheal (DRUG).
Who is sponsoring clinical trial NCT04640896?
This trial is sponsored by George Washington University, which has 133 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04640896 being conducted?
This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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