Trigger Point Injection for Myofascial Pain Syndrome in the Low Back (T-PIMPS): A Randomized Controlled Trial.
Madigan Army Medical Center
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.
Description
Significance: Low back pain (LBP) is a common presenting complaint in the Emergency Department (ED), accounting for 2.63 million visits in the united states and 2.3 percent of ED visits annually.1 An estimated 100 billion dollars per year is lost from low back pain. One-third of this is direct costs.2 For the United States military, in 2015, 195,844 acute cases of LBP were identified, leading to significant loss of person-hours.3 The definitions of durations, or types, of LBP vary among sources. For example, the American Association of Family Physicians defines acute low back pain as six to 12…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Age ≥ 18 years 2. Must have at least 1 trigger point in low back paraspinal muscles. 3. For exacerbations of chronic low back pain, the pain on presentation must be 1.5 cm above baseline pain on VAS Exclusion Criteria: 1. Allergy or inability to take study medications. 2. New focal neurologic deficit in lower extremities. 3. Known active malignancy with bony spinal metastases. 4. Identifiable spinal, lumbosacral or hip fracture. 5. History of Fibromyalgia, rheumatoid arthritis, ankylosing spondylitis. 6. Current use of anticoagulation. 7. Overlying cellulitis. 8. Spin…
Interventions
- DrugTreatment of Myofascial Pain Syndrome in the low back. This intervention will be based on outcomes of the medications listed below.
We 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.
- DrugEvaluation 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.
Evaluation 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.
- DrugFollowing up with participants 60-72 hours after treatment in the Emergency Department. This intervention will be based on outcomes of the medications listed below.
60-72 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.
Location
- Department of Emergency Medicine, Madigan Army Medical CenterTacoma, Washington