Using Structural Health Monitoring to Improve Diagnosis and Treatment of Low Back Injury in U.S. Service Members- Phase 2

Completed · Not applicable · Has a placebo group

Conditions studied: Low Back Pain

In brief

The focus of this project is to evaluate the diagnostic utility of Shear Wave Elastography (SWE) in individuals after routine low back injury and begin an initial investigation of it's ability to effectively guide physical therapy treatment with dry-needling as a relevant treatment intervention. Specific Aim #1: Evaluate the diagnostic utility of SWE in differentiating individuals with and without LBP. The investigators will also examine the interaction between tissue change and clinical improvement. The investigators hypothesize that individuals with LBP will have higher muscle stiffness (shear modulus) at rest and impaired (lower) stiffness during contraction than individuals without LBP. Specific Aim #2: Evaluate the effectiveness of dry-needling in decreasing aberrant muscle stiffness in individuals with LBP. The investigators hypothesize that individuals with LBP that receive dry-needling will exhibit larger changes than both individuals with LBP that receive sham dry-needling and than individuals without LBP that receive dry-needling. Specific Aim #3: Evaluate the effectiveness of dry-needling in decreasing pain and disability in individuals with LBP. The investigators hypothesize that individuals with LBP that receive dry-needling will exhibit larger improvements than individuals with LBP that receive sham dry-needling.

Key facts

Study ID

NCT02352532

Run by

Baylor University

People needed

90

Starts

2015-01-01

Expected to finish

2016-08-01

Last updated by the study team

2017-07-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Between the age of 18 - 65 years
• Read and speak English well enough to provide informed consent and follow study instructions
• Active duty military or DOD beneficiary
• History of prior surgery to the lumbosacral spine
• Received manual therapy, acupuncture, or dry-needling interventions to the lumbosacral spine within the past 4 weeks
• Currently taking anticoagulant medications or those individuals with a medical history of bleeding disorder
• History of systemic inflammatory disease or other serious spinal pathology (e.g. annular tears of the intervertebral disc, spinal stenosis, fracture)
• Known pregnancy and/or inability to lie prone and fully elevate bilateral arms
• Presence of neurogenic LBP defined by either a positive ipsilateral or contralateral straight leg raise (reproduction of symptoms at <45°) or reflex, sensation, or strength deficits in a pattern consistent with nerve root compression
• Medical "red flags" of a potentially serious condition including cauda equina syndrome, major or rapidly progressing neurological deficit, fracture, cancer, infection, or systemic disease

You may not qualify if…

• History of prior surgery to the lumbosacral spine
• Received manual therapy, acupuncture, or dry-needling interventions to the lumbosacral spine within the past 4 weeks
• Currently taking anticoagulant medications or those individuals with a medical history of bleeding disorder
• History of systemic inflammatory disease or other serious spinal pathology (e.g. annular tears of the intervertebral disc, spinal stenosis, fracture)
• Known pregnancy and/or inability to lie prone and fully elevate bilateral arms
• Presence of neurogenic LBP defined by either a positive ipsilateral or contralateral straight leg raise (reproduction of symptoms at <45°) or reflex, sensation, or strength deficits in a pattern consistent with nerve root compression
• Medical "red flags" of a potentially serious condition including cauda equina syndrome, major or rapidly progressing neurological deficit, fracture, cancer, infection, or systemic disease

Where it is running

• Army Medical Department Center and Schools — Fort Sam Houston, Texas, United States

Full record on ClinicalTrials.gov

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