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RecruitingAccepts healthy volunteersPhase 4

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

Madigan Army Medical Center · NCT04704297

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 4
Target enrollment
180
US sites recruiting
1
Study start
December 28, 2020
Record last updated
January 12, 2021

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: 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.

Conditions: Low Back Pain; Myofascial Pain Syndrome Lower Back

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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).

Recruiting US locations

  • Department of Emergency Medicine, Madigan Army Medical Center

    Tacoma, WA 98431

    Site contact: Joshua J Oliver, MD · 360-393-9024 · joshua.j.oliver6.mil@mail.mil

Study contacts (from the official record)

  • Joshua J Oliver, MD · (360) 393-9024 · joshua.j.oliver6.mil@mail.mil
  • Kyle S Couperus, MD · (315) 323-2029 · kyle.s.couperus.mil@mail.mil
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Trigger Point Injection for Myofascial Pain Syndrome in the Low… (NCT04704297) | Bored Studies