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New treatment option for Low Back Pain
Official title Trigger Point Injection for Myofascial Pain Syndrome in the Low Back: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT04704297
What this study is testing
What is Treatment of Myofascial Pain Syndrome in the low back. This intervention will be based on outcomes of the medications listed below.?
Treatment of Myofascial Pain Syndrome in the low back. This intervention will be based on outcomes of the medications listed below. is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for low back pain.
Also referred to as Ketorolac, acetaminophen, ibuprofen, cyclobenzaprine, bupivacaine, normal saline.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Tacoma, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tacoma, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.