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Investigating the Minimum Number of Needling Required to Optimize Trigger Point Injections Outcome

NCT04732507 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-01-08

No results posted yet for this study

Summary

Myofascial pain is a common condition in which patients may experience severe chronic pain. The source of this pain is typically the soft tissue. Current methods to address myofascial pain include a procedure called Trigger point Injections. This method involves identifying the areas of muscles that are causing the pain. The most common way to perform trigger point injection involves infiltrating the muscle with local anesthetics and then repeatedly passing the numbing needle in and out of the muscles (needling). This procedure is successful for most patients. However, there is great variability in the way needling is done. Some pain physicians perform 1-2 needle passes while other pain physicians may exceed 20 passes. There are currently no guidelines as to the number or amount of needle passes needed to achieve pain control. Furthermore, there is no study or research to shed light on the relationship between the number of needles passes and the degree and duration of pain relief coupled with patients' satisfaction.

This study is proposed to address this gap in knowledge. It is a prospective and randomized clinical trial that follows the standard of care. The investigators will recruit patients from The University-Banner Medical Center at Tucson, Arizona chronic pain clinic who are candidates for trigger point injections. The participants will be randomized into 3 different groups. Group one will receive 2 needle passes per identified trigger point. Group two will receive ten needle passes per identified trigger point. Group three will receive twenty needle passes per identified trigger point.

The investigators will analyze the data to understand the relationship between the number of needles passes and the degree of pain relief, improved functional capacity, and patients' satisfaction.

Conditions

  • Myofascial Pain
  • Myofascial Trigger Point Pain

Interventions

COMBINATION_PRODUCT

1% plain lidocaine and 0.25% plain bupivacaine

A 5- or 10-ml syringe will be filled equally with 1% plain lidocaine and 0.25% plain bupivacaine. A 1.5-inch 25-gauge needle will be attached to the syringe. The needle will be carefully inserted at the first trigger point and 2 mls of the mixed local anesthetic will be infiltrated. At that point, the needle will be carefully inserted into the trigger point based on the group assigned. Once needling is done for the first trigger point, the process will be repeated in exactly the same fashion for the remaining points.

Sponsors & Collaborators

  • University of Arizona

    lead OTHER

Principal Investigators

  • Mohab Ibrahim, Md., Ph.D · University of Arizona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-20
Primary Completion
2026-12-09
Completion
2026-12-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04732507 on ClinicalTrials.gov