Trigger Point Injection for Myofascial Pain Syndrome in the Low Back: A Randomized Controlled Trial
Status:
Recruiting
Trial end date:
2022-07-01
Target enrollment:
Participant gender:
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 is most beneficial.