About this 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 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥ 18 years
Must have at least 1 trigger point in low back paraspinal muscles.
For exacerbations of chronic low back pain, the pain on presentation must be 1.5 cm above baseline pain on VAS
Disqualifiers
Allergy or inability to take study medications.
New focal neurologic deficit in lower extremities.
Known active malignancy with bony spinal metastases.
Identifiable spinal, lumbosacral or hip fracture.
Trial design
Parallel
Treatments tested in this trial
Treatment of Myofascial Pain Syndrome in the low back. This intervention will be based on outcomes of the medications listed below.
DrugWe are testing which of the three arms is superior for the treatment of Myofascial Pain Syndrome of the Low Back. Pain will be measured using a 10 cm visual analogue scale (VAS) at baseline and 30-minutes after treatment.
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.
DrugEvaluation of functional ability using a patient centered functional score known as the MODI. The MODI will be scored at baseline and 30-minutes after treatment.
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.
Drug60-72 after treatment in the Emergency Department, a member of the study team will follow up with participants to repeat a measurement of pain and functional ability on VAS and MODI respectively. This will be compared to baseline measurements.
Treatment groups
Trial outcomes
Primary outcomes
Pain reduction
To determine which of three treatments is the superior treatment for myofascial pain syndrome (MPS) of the low back. The three treatments are standard therapy (ST), ST plus trigger point injections (TPI) with 8 mL of 0.5% Bupivacaine, and ST plus TPI with 8 mL of normal saline NS. To reach superiority a treatment will have to decrease pain by 1.5 cm more than the other treatments, measured before treatment and 30-minutes following treatment on a 10 cm visual analog scale (VAS). The units of measurement are centimeters (cm) on a VAS.
Secondary outcomes
Functional Improvement
To incorporate a patient centered functional score into the study and measure the difference in scores before treatment and 30-minutes following treatment. We will use the Modified Oswestry Disability Index (MODI), a previously validated index. To reach superiority, a treatment will have to decrease MODI by 10 points more than the other treatments. The MODI produces a measurement in percentages ranging from 0 to 100. The measurement will therefore be a percentage.
Other outcomes
Follow-up measurement of pain
To follow-up with participants via telephone 60-72 hours after treatment and repeat a pain measurement on a 10 cm VAS. The same measures of superiority will be applied comparing the baseline measurement to the measurement at 60-72 hours. The unit of measurement will be cm on a VAS.
Follow-up measurement of function
To follow-up with participants via telephone 60-72 hours after treatment and repeat a functional score on a MODI. The same measures of superiority will be applied comparing the baseline measurement to the measurement at 60-72 hours. The unit of measurement will be percentage on a MODI.
Sponsors and contacts
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