What is the mechanism of action of this treatment?

Trigger Point Injections (TPIs) with local anesthetics and needling are common treatments for Myofascial Pain Syndrome (MPS). TPIs involve injecting a local anesthetic into myofascial trigger points to numb the area, reduce pain, and interrupt the pain cycle. Needling helps break up tight muscle bands and trigger points, promoting muscle relaxation and improved blood flow. These treatments are important for MPS patients as they directly target the source of pain, providing relief and improving muscle function.

What side effects are associated with this type of intervention?

The most common treatment for Myofascial Pain Syndrome, Trigger Point Injections with local anesthetics, involves needling the muscle to alleviate pain. Known side effects include temporary pain at the injection site, muscle stiffness, and, in some cases, post-injection headaches. Prolotherapy, another similar treatment, can cause temporary increases in pain and stiffness, and occasionally headaches. Botulinum toxin injections may lead to transient muscle weakness and, less commonly, prolonged weakness in the injected area.

What prior FDA approvals exist?

The FDA has approved various treatments for Myofascial Pain Syndrome, including the use of local anesthetics for Trigger Point Injections. These injections involve infiltrating the muscle with local anesthetics, such as lidocaine or bupivacaine, to alleviate pain by targeting specific trigger points. This method is widely used and has shown effectiveness in reducing pain and improving functional capacity in patients with myofascial pain.

What other types of research exist?

Promising novel alternatives to Trigger Point Injections for Myofascial Pain Syndrome include: <ol> <li>Extracorporeal Shock Wave Therapy (ESWT) - This non-invasive treatment has shown efficacy in various musculoskeletal conditions.</li> <li></li> </ol> Acupuncture - Systematic reviews suggest it can be effective for pain management. 3. Botulinum Toxin Injections - Studies indicate potential benefits for chronic pain conditions. 4. Prolotherapy - This involves injecting an irritant solution to stimulate healing and has shown promise in pilot studies. 5. Percutaneous Needle Tenotomy - This minimally invasive procedure has demonstrated effectiveness in treating tendinosis and may be applicable to myofascial pain.

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Procedure

Trigger Point Injections for Myofascial Pain

Phase 2

Waitlist Available

Led By Mohab Ibrahim, Md., Ph.D

Research Sponsored by University of Arizona

Eligibility Criteria Checklist

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

Must have

Diagnosis of myofascial pain

Failed conservative therapy or unable to participate in physical therapy

Must not have

Serious mental illness that may not enable the patient to perceive pain changes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 days

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial studies how different numbers of needle passes during trigger point injections affect pain relief in patients with chronic myofascial pain. The treatment involves injecting a numbing medicine into painful muscle areas and moving the needle in and out multiple times. The goal is to find out which method provides the best pain relief.

Who is the study for?

This trial is for English-speaking individuals with myofascial pain who haven't found relief through conservative treatments or can't do physical therapy. It's not suitable for those with serious mental illnesses that affect pain perception or conditions causing widespread pain.

What is being tested?

The study tests how many needle passes in trigger point injections (using lidocaine and bupivacaine) are best for relieving chronic muscle pain. Participants will be randomly assigned to receive either 2, 10, or 20 needle passes at a clinic in Tucson, Arizona.

What are the potential side effects?

Possible side effects from the injections may include temporary discomfort at the injection site, bruising, bleeding, allergic reactions to the anesthetics used (lidocaine and bupivacaine), and rarely nerve damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with muscle pain.

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Physical therapy did not work for me or I cannot do it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a mental illness that affects my ability to feel changes in pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in pain intensity

Secondary study objectives

Change in Sleep patterns

Perceived Subjective Changes in the Ability to Work, Do Chores, and Exercise.

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 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Active Control

Group I: One to two needle passesActive Control1 Intervention

Receive 1-2 needle passes for needling at each trigger point

Group II: Ten needle passesActive Control1 Intervention

Receive 10 needle passes for needling at each trigger point

Group III: Twenty needle passesActive Control1 Intervention

Receive 20 needle passes for needling at each trigger point

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Trigger Point Injections (TPIs) with local anesthetics and needling are common treatments for Myofascial Pain Syndrome (MPS). TPIs involve injecting a local anesthetic into myofascial trigger points to numb the area, reduce pain, and interrupt the pain cycle. Needling helps break up tight muscle bands and trigger points, promoting muscle relaxation and improved blood flow. These treatments are important for MPS patients as they directly target the source of pain, providing relief and improving muscle function.