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

Part of paid clinical trials in Tacoma, Washington.

Sponsor
Madigan Army Medical Center
Study ID
NCT04704297
Phase
PHASE4
Status
Recruiting
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Conditions

  • Low Back Pain
  • Myofascial Pain Syndrome Lower Back

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 28, 2020
Status verified
Jan 2021
Primary completion
Jul 1, 2022
Completion
Jul 1, 2022

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard Therapy (ST)
    ST will consist of 975mg of Acetaminophen PO and either 30mg of Ketorolac IM or 15 mg IV. Upon discharge ST will consist of prescriptions for acetaminophen 650mg every 4 hours by mouth, Ibuprofen 400mg every 4 hours by mouth, and 10 mg of cyclobenzaprine nightly by mouth. Additionally, participants will be provided a handout going over these medications and the use of heat for low back pain and instructions on the performance of McKenzie stretching exercises for low back pain.4
  • Active Comparator: ST plus Trigger Point Injections (TPI) with 8 mL of 0.5 percent Bupivacaine
    ST plus TPI with 8 mL of 0.5 percent Bupivacaine
  • Active Comparator: ST plus TPI with 8 mL of Normal Saline (NS)
    ST plus TPI with 8 mL of Normal Saline

Primary Outcome Measure

Pain reduction [ Time Frame: 30-minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Department of Emergency Medicine, Madigan Army Medical CenterTacomaWashington98431
Joshua J Oliver, MD
[email protected]
360-393-9024
Kyle S Couperus, MD
[email protected]
(315) 323 2029

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By research site
Department of Emergency Medicine, Madigan Army Medical Center· Tacoma, WA

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