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NCT04704297 · ClinicalTrials.gov registry record · Phase 4

Trigger Point Injection for Myofascial Pain Syndrome in the Low Back: A Randomized Controlled Trial

A Phase 4 study of Low Back Pain and Myofascial Pain Syndrome - Lower Back, sponsored by Madigan Army Medical Center.

Recruiting
Registry status
Phase 4
Development phase
180
Enrollment target
1
Study location

NCT04704297 is a Phase 4 study of Low Back Pain and Myofascial Pain Syndrome - Lower Back that is actively recruiting participants, run by Madigan Army Medical Center. The registered enrollment target is 180 participants, below the 502-participant average among 122 other Low Back Pain trials with a reported enrollment target (64% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04704297, a Phase 4 study of Low Back Pain and Myofascial Pain Syndrome - Lower Back, is actively recruiting participants, sponsored by Madigan Army Medical Center.

RECRUITING
Registry status
Phase 4
Development phase
180 participants
Enrollment target
1
Study location

Study Summary

Rationale: Low back pain (LBP), or myofascial pain syndrome (MPS) of the low back, accounts for approximately 2.63 million visits in the United States, or 2.3 percent of annual Emergency Department (ED) visits. An estimated 100 billion dollars per year is lost from LBP. Approximately one-third of this is direct costs. Previous studies have established the safety of trigger point injections (TPI). However, the results of these studies are highly heterogeneous regarding TPI's ability to treat pain or improve functional outcomes. The two most promising TPI studies conducted in the ED have been published in the last two years. They both suffered from a small sample size. Additionally, they suffered from a combination of limitations including: lack of randomization, inconsistent medical management, lack of a follow-up assessment, and lack of patient centered functional outcomes. These studies were both two armed and either compared standard medical management to TPI with local anesthetic or TPI with local anesthetic to TPI with Normal Saline (NS). One of these studies concluded that TPI is generally beneficial. The other concluded that TPI with NS is superior. Research Hypothesis: The investigators hypothesize that standard therapy (ST) plus TPI with 8 mL of 0.5 percent Bupivacaine is superior to ST alone or ST plus TPI with 8 mL of NS for the treatment of the pain associated with MPS of the low back. Significance: This will be the first TPI study to compare ST, to TPI with local anesthetic, and TPI with NS for LBP conducted in an ED. It will also be the first TPI study to incorporate a patient centered functional outcome and patient follow-up after discharge from an ED. TPI's are a popular treatment modality for LBP among many Emergency Medicine Providers. However, to date, there is limited evidence for or against it. The investigators are hopeful that this study will answer whether or not trigger point injections are benefiting patients and, if so, which type of TPI

Interventions

  • DRUG Treatment of Myofascial Pain Syndrome in the low back. This intervention will be based on outcomes of the medications listed below.
  • DRUG Evaluation of functional ability using a patient centered functional score known as the Modified Oswestry Disability Index (MODI). The intervention will be based on outcomes of medications below.
  • DRUG Following up with participants 60-72 hours after treatment in the Emergency Department. This intervention will be based on outcomes of the medications listed below.

Study Locations (1)

Washington

  • Department of Emergency Medicine, Madigan Army Medical Center - Tacoma

Trial Details

FieldValue
Enrollment Target 180 participants
Start Date 2020-12-28
Est. Completion 2022-07-01
Phase Phase 4

Sponsor

Madigan Army Medical Center

22 total trials

What the Registry Record Tells You About NCT04704297

The ClinicalTrials.gov registry entry for NCT04704297 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 502-participant average among 122 other Low Back Pain trials with a reported enrollment target (64% lower). The listed sponsor is Madigan Army Medical Center, which has 22 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Low Back Pain appearing as the primary indexed condition, and to 3 interventions - of which Treatment of Myofascial Pain Syndrome in the low back. This intervention will be based on outcomes of the medications listed below. is the first listed.

NCT04704297 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.

Frequently Asked Questions

What is clinical trial NCT04704297 about?

NCT04704297 is a clinical study titled "Trigger Point Injection for Myofascial Pain Syndrome in the Low Back: A Randomized Controlled Trial". Rationale: Low back pain (LBP), or myofascial pain syndrome (MPS) of the low back, accounts for approximately 2.63 million visits in the United States, or 2.3 percent of annual Emergency Department (ED) visits. An estimated 100 billion dollars per year is lost from LBP. Approximately one-third of th...

What is the current status of trial NCT04704297?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 180 participants. The study started on 2020-12-28. Estimated completion is 2022-07-01.

What conditions does trial NCT04704297 study?

This clinical trial studies the following conditions: Low Back Pain, Myofascial Pain Syndrome - Lower Back.

What interventions are being tested in trial NCT04704297?

The interventions under investigation include: Treatment of Myofascial Pain Syndrome in the low back. This intervention will be based on outcomes of the medications listed below. (DRUG), Evaluation of functional ability using a patient centered functional score known as the Modified Oswestry Disability Index (MODI). The intervention will be based on outcomes of medications below. (DRUG), Following up with participants 60-72 hours after treatment in the Emergency Department. This intervention will be based on outcomes of the medications listed below. (DRUG).

Who is sponsoring clinical trial NCT04704297?

This trial is sponsored by Madigan Army Medical Center, which has 22 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04704297 being conducted?

This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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