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

RecruitingPhase 4Ages 18 Years - anyAllMadigan Army Medical Center
NCT04704297 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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. Spinal, hip, or pelvic surgery within the past 6 months. 9. Previous administration of trigger point injections for current episode. 10. Sciatica-extending down the back of the leg to the heel. 11. Alternate identifiable cause of participant's acute pain other than myofascial or musculoskeletal pain. 12. Febrile patients. 13. Pregnant 14. 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).
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What it tests

  • Treatment of Myofascial Pain Syndrome in the low back. This intervention will be based on outcomes of the medications listed below.
  • 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.
  • 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.
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Where

1 site
Department of Emergency Medicine, Madigan Army Medical Center
Tacoma, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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