Trigger Point Injection for Myofascial Pain Syndrome in the Low Back: A Randomized Controlled Trial
Recruiting · NCT04704297 · Interventional (participants receive a specific treatment) · Lead sponsor: Madigan Army Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- 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.
- History of Fibromyalgia, rheumatoid arthritis, ankylosing spondylitis.
- Current use of anticoagulation.
- Overlying cellulitis.
- Spinal, hip, or pelvic surgery within the past 6 months.
- Previous administration of trigger point injections for current episode.
- Sciatica-extending down the back of the leg to the heel.
- Alternate identifiable cause of participant's acute pain other than myofascial or musculoskeletal pain.
- Febrile patients.
- Pregnant
- Unable to understand English or otherwise unable to provide informed consent (mental handicap, inability to understand instructions, risks, or benefits), or is an at risk population (wounded warrior, resident physicians, prisoners, cadets, midshipmen, or students).
Where it is running
1 location listed across 1 US state.
- Department of Emergency Medicine, Madigan Army Medical Center - Tacoma, Washington, United States