Trigger Point Injection for Myofascial Pain Syndrome in the Low Back: A Randomized Controlled Trial (NCT04704297)
Trigger Point Injection for Myofascial Pain Syndrome in the Low Back (T-PIMPS): A Randomized Controlled Trial.
๐ฉบ Plain-English Summary (8th-Grade Level)
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 join: Review the eligibility criteria below.
Location: Department of Emergency Medicine, Madigan Army Medical Center โ Tacoma, Washington
Age range: 18 Years
๐งช Interventions in This Study
- Treatment of Myofascial Pain Syndrome in the low back. This intervention will be based on outcomes of the medications listed below. (DRUG)
- 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. (DRUG)
- 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. (DRUG)
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (1 Sites)
- Department of Emergency Medicine, Madigan Army Medical Center โ Tacoma, Washington
๐ Contact the Study Coordinator
Phone: (360) 393-9024
Email: joshua.j.oliver6.mil@mail.mil
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Low Back Pain
- Nonpharmacologic Pain Management in FQHC Primary Care Clinics โ Salt Lake City, Utah
- Non-surgical Spinal Decompression Therapy and Outcomes โ Stanford, California
- Non-pharmacological Treatment for Pain After Spine Surgery โ Honolulu, Hawaii
- TeleYoga for Chronic Low Back Pain: A Quantitative and Qualitative Study โ Kansas City, Kansas
- SMART Stepped Care Management for Low Back Pain in the Military Health System โ Schofield Barracks, Hawaii
- Intracept Intraosseous Basivertebral Nerve Ablation โ Farmington, Utah
Explore by condition: All Low Back Pain clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.