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Trigger Point Injections for Neck Pain

Phase 4

Recruiting

Research Sponsored by George Washington University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 hours after intervention

Awards & highlights

Study Summary

This trial is testing whether trigger point injections can help relieve myofascial pain (muscle pain) for people who have had anterior neck surgery.

Who is the study for?

This trial is for patients scheduled for elective anterior neck surgery who often experience postoperative neck stiffness and pain. It's not suitable for those with emergency surgeries, allergies to local anesthetics, long-term opioid use (except tramadol and codeine), or complications during surgery leading to an unstable cervical spine.Check my eligibility

What is being tested?

The study tests if trigger point injections with bupivacaine or normal saline can reduce myofascial pain after neck surgery better than standard care alone. The goal is to see if this treatment decreases the need for narcotic pain medication post-surgery.See study design

What are the potential side effects?

Possible side effects from the injections may include temporary discomfort at the injection site, bruising, infection risk, and allergic reactions to the numbing medications used.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 hours after intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 hours after intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 hours after intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Opioid consumption in the first 12 hour period after intervention (trigger point injection/sham)

Opioid consumption in the first 24 hour period after intervention (trigger point injection/sham)

Opioid consumption in the first 6 hour period after intervention (trigger point injection/sham)

Secondary outcome measures

Pain score at 12 hours after intervention (trigger point injection/sham)

Pain score at 24 hours after intervention (trigger point injection/sham)

Pain

+1 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Trigger point injection with bupivacaineExperimental Treatment1 Intervention

Trigger point injections in the rhomboid and trapezius regions with up to 20cc of 0.25% bupivacaine hydrochloride + intra- and postoperative standardized analgesia regimen

Group II: Trigger point injection with normal salineActive Control1 Intervention

Trigger point injections in the rhomboid and trapezius regions with up to 20cc of 0.9% Normal Saline + intra- and postoperative standardized analgesia regimen

Group III: Lidocaine skin whealPlacebo Group1 Intervention

They will receive an injection of lidocaine in the skin over the area of the trigger points. While this causes a small area of numbness, it is not a trigger point injection.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

George Washington UniversityLead Sponsor

243 Previous Clinical Trials

453,714 Total Patients Enrolled

Media Library

Trigger point injection with bupivacaine Clinical Trial Eligibility Overview. Trial Name: NCT04640896 — Phase 4

Myofascial Pain Research Study Groups: Lidocaine skin wheal, Trigger point injection with normal saline, Trigger point injection with bupivacaine

Myofascial Pain Clinical Trial 2023: Trigger point injection with bupivacaine Highlights & Side Effects. Trial Name: NCT04640896 — Phase 4

Trigger point injection with bupivacaine 2023 Treatment Timeline for Medical Study. Trial Name: NCT04640896 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are participating in this experiment?

"Affirmative. Per records posted on clinicaltrials.gov, this research is currently seeking participants; the posting was first published on November 5th 2020 and last updated October 7th 2022. The trial requires 60 patients to join at a single site."

Answered by AI

What safety protocols should be followed when administering trigger point injections with bupivacaine?

"The safety of Trigger Point Injection with Bupivacaine is ranked a 3, as this treatment has already been approved by the FDA and classified as Phase 4."

Answered by AI

What medical conditions are typically addressed with Trigger point injection and bupivacaine?

"Trigger point injection with bupivacaine is typically used to heal minor burns. However, this technique may also be employed to mitigate the symptoms of lupus erythematosus cell and ulcerative colitis as well as assist in transplantation procedures."

Answered by AI

What aims does this investigation seek to accomplish?

"The purpose of this clinical trial, which requires 12 hours of observation post-intervention, is to gauge the efficacy of opioid reduction in a 6 hour period. Pain scores will be measured using visual analog scale (VAS), where 0 denotes no pain and 10 indicates the worst imaginable anguish. Secondary objectives include additional VAS assessments at 12 and 24 hours after intervention."

Answered by AI

What have past investigations revealed about Trigger point injection with bupivacaine?

"Currently, there are 222 active clinical trials exploring the use of bupivacaine for trigger point injection. Of those, 53 have advanced to Phase 3. Although the majority of these studies take place in Germantown, Tennessee; a total of 1495 sites across the world are currently conducting research on this topic."

Answered by AI

Are there any available slots for people to join this medical experiment?

"Available information on clinicaltrials.gov reveals that this particular study is actively seeking out participants. Initially posted in November of 2020, the trial was most recently revised in October 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trigger Point Injections in Anterior Cervical Surgery

Anita Vincent 2020. "Trigger Point Injections in Anterior Cervical Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04640896.

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