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

NCT04732507 | Enrolling By Invitation Phase 2 FDA Drug

• 1 other identifier: 04122020
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in pain intensity

  The primary outcome is the length of time patients subjectively report at least 50 percent reduction in pain compared to their baseline following trigger point injections using the Numerical Pain Scale which ranges from 0-10, where 0 = no pain and 10 = the worst possible pain.

  60 days

Secondary Outcomes (2)

• Change in Sleep patterns

  60 days

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

  60 days

Study Arms (3)

One to two needle passes

ACTIVE COMPARATOR

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

Combination Product: 1% plain lidocaine and 0.25% plain bupivacaine

Ten needle passes

ACTIVE COMPARATOR

Receive 10 needle passes for needling at each trigger point

Combination Product: 1% plain lidocaine and 0.25% plain bupivacaine

Twenty needle passes

ACTIVE COMPARATOR

Receive 20 needle passes for needling at each trigger point

Combination Product: 1% plain lidocaine and 0.25% plain bupivacaine

Interventions

1% plain lidocaine and 0.25% plain bupivacaine COMBINATION_PRODUCT

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.

One to two needle passes; Ten needle passes; Twenty needle passes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to speak, read and write English
• Diagnosis of myofascial pain
• Failed conservative therapy or unable to participate in physical therapy

You may not qualify if:

• Serious mental illness that may not enable the patient to perceive pain changes
• History of conditions which may present as diffuse pain

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

Banner University Medical Center Multispecialty Services Clinic

Tucson, Arizona, 85711, United States

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Mohab Ibrahim, Md., Ph.D

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Anesthesiology

Model Details: Depending on assignment, one group will receive 1-2 needle passes at each trigger point, the other will receive 10 and the third will receive 20.

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: February 1, 2021
• Study Start: April 20, 2021
• Primary Completion (Estimated): December 9, 2026
• Study Completion (Estimated): December 9, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

US (1)