Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04732507 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusEnrolling by Invitation
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary and study completion dates: Dec 9, 2025 to Dec 9, 2026v8
  2. Notable Primary and study completion dates: Dec 9, 2024 to Dec 9, 2025v7
  3. Notable Primary completion date: Dec 31, 2023 to Dec 9, 2024
    • Study completion date: Jul 31, 2024 to Dec 9, 2024
    v6
  4. Minor 2 versions Re-verified since Oct 3, 2022, no change to tracked fieldsv4-v5
  5. Notable Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Start date changed from estimate of Feb 15, 2021 to Apr 20, 2021
    • Site contact updated
    v3
  6. Minor Secondary endpoints: details revised at 2 of 2 entriesv2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04732507
Lead Sponsor University of Arizona
Conditions
(from sponsor)
Myofascial Pain, Myofascial Trigger Point Pain
Related terms Myofascial Pain Syndromes
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov