Actively Recruiting

Phase 4
Age: 18Years +
All Genders
Healthy Volunteers
NCT04704297

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

Led by Madigan Army Medical Center · Updated on 2021-01-12

180

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Presence of at least one trigger point in low back paraspinal muscles
  • For worsening chronic low back pain, pain level must be at least 1.5 cm higher than baseline on a visual analog scale (VAS)
Not Eligible

You will not qualify if you...

  • Allergy or inability to take the study medications (acetaminophen, ketorolac, ibuprofen, cyclobenzaprine)
  • New focal neurological problems in the lower limbs
  • Active cancer with bone metastases in the spine
  • Known fractures of the spine, lumbosacral area, or hip
  • History of fibromyalgia, rheumatoid arthritis, or ankylosing spondylitis
  • Currently taking anticoagulant medications
  • Skin infection over the injection area
  • Spinal, hip, or pelvic surgery within the past 6 months
  • Previous trigger point injections for the current episode
  • Sciatica pain extending down the leg to the heel
  • Other identifiable causes of acute pain besides myofascial or musculoskeletal pain
  • Fever at the time of evaluation
  • Pregnant women
  • Unable to understand English or provide informed consent, including certain at-risk populations (wounded warriors, residents, prisoners, cadets, midshipmen, students)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Department of Emergency Medicine, Madigan Army Medical Center

Tacoma, Washington, United States, 98431

Actively Recruiting

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Research Team

J

Joshua J Oliver, MD

CONTACT

K

Kyle S Couperus, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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