Using Structural Health Monitoring to Improve Diagnosis and Treatment of Low Back Injury in U.S. Service Members- Phase 2
Condition: Low Back Pain
MeSH terms: Low Back Pain; Back Injuries
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      Low back pain (LBP) is the second most frequent reason for health care visits and a leading
      cause of medical evacuation from theater. Traditional medical diagnosis based on static
      imaging strategies (e.g. MRI) has failed to improve management of this epidemic. Functional
      assessment of lumbar musculature using ultrasound imaging provides evidence of clinically
      relevant deficits in the lumbar multifidus (LM) muscle of patients with LBP, however such
      procedures are likely only valid within a narrow range of assessment conditions. Shear-Wave
      Elastography (SWE) is an evolving non-invasive ultrasound imaging technology capable of
      quantifying tissue stiffness (i.e., elasticity). Originally developed to improve diagnosis of
      soft tissue tumors, SWE is beginning to be used to as an alternative and more stable method
      of functional assessment of muscles.

      This study will be the second project in a line of research aimed at improving the diagnosis,
      management, and treatment of patients with LBP using a new structural health monitoring
      technique called shear wave elastography (SWE). Since no previous studies had used SWE in the
      lumbar multifidus muscle, the initial project developed the measurement technique to be used
      with this device. We also established normative parameters, variance, and reliability
      estimates of SWE outcomes in asymptomatic individuals. A previous study, also performed at
      AMEDDC&S, found that individuals with LBP whom received dry needling to the lumbar multifidus
      muscle exhibited a reduction in pain and disability that was associated with an improved
      ability to contract the lumbar multifidus. The focus of this second project is to evaluate
      the diagnostic utility of 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.
    

Intervention name(s): Dry Needling; Sham Needling
Intervention type(s): Other; Other
Intervention description(s): The dry-needling treatment will consist of inserting a sterile needle into needling the prone participant's lumbar multifidus and paraspinal muscles, 1-2 times each, in regions of local tenderness to palpation and/or regions with palpable trigger points. All needling treatment will be performed with FDA approved (FDA regulation # 880.5580) disposable 0.30 x 50-60 mm stainless steel Seirin J-type needles (Seirin, Japan). Each needle insertion will last approximately 5 seconds using a "pistoning" (in and out) technique.; The sham dry-needling procedure will mimic the dry needling procedures by placing a sharp object in a needling guide tube against the skin (see figure). The sharp object will be rocked and twisted to simulate treatment, but will not pierce the skin. We have used this sham dry-needling technique in a previous study performed at AMEDDC&S and have found it to be indistinguishable from real dry needling by the great majority of participants.
Other intervention name(s): Trigger point dry needling
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dry Needling; Shear Wave Elastography; Ultrasound