Status:
RECRUITING
Trigger Point Injection for Myofascial Pain Syndrome in the Low Back: A Randomized Controlled Trial
Lead Sponsor:
Madigan Army Medical Center
Conditions:
Low Back Pain
Myofascial Pain Syndrome Lower Back
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 (E...
Detailed Description
Significance: Low back pain (LBP) is a common presenting complaint in the Emergency Department (ED), accounting for 2.63 million visits in the united states and 2.3 percent of ED visits annually.1 An ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2022
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04704297
Start Date
December 28 2020
End Date
July 1 2022
Last Update
January 12 2021
Active Locations (1)
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1
Department of Emergency Medicine, Madigan Army Medical Center
Tacoma, Washington, United States, 98431