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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

All Individual Drugs Already Approved

Approved for 20 Other Conditions

Pivotal Trial

Drug Has Already Been Approved

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 20 Other Conditions

This treatment demonstrated efficacy for 20 other conditions.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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.

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