Feasibility of Near-infrared Spectroscopy to Measure Cortical Pain Pathway (Brain) Activation During Dry Needling
Condition: Shoulder Pain; Chronic Pain; Musculoskeletal Injury
MeSH terms: Shoulder Pain; Chronic Pain
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The benefit experienced by some patients when treated with dry needling,1 combined with the
      field-expedient nature of this intervention, make dry needling uniquely suited for the
      military healthcare environment. An improved understanding of the mechanism by which dry
      needling exerts its clinical benefits will allow clinicians to adopt more efficacious
      treatment strategies for Soldiers with chronic musculoskeletal pain. The proposed study will
      utilize functional near-infrared spectroscopy and structural health monitoring (SHM) to
      provide insight on the central and peripheral mechanisms of dry needling. Phase 1 will
      compare the cortical pain pathway response of thirty participants with non-traumatic shoulder
      pain receiving either true or sham dry needling. An additional 15 participants will be
      enrolled to receive true dry needling to determine if brain responses may be able to predict
      clinical improvement (responders versus non-responders) in phase 2. Since chronic pain after
      musculoskeletal injury is the leading cause of medical discharge from service and a primary
      source of disability in the U.S. military2,3, improved complementary and alternative
      treatment strategies have the potential to have a large impact on both military readiness and
      health care costs within the Armed Forces.
    

Detailed description: 
      This study supports a line of ongoing investigation aimed at improving the diagnosis,
      management, and treatment of chronic pain after musculoskeletal injury. Continued progress in
      this arena requires novel methods to measure central nervous system (brain) mechanism of
      action and its role in identification of the unique transition of musculoskeletal injury to
      chronic pain. The purpose of this study is to use near-infrared spectroscopy (NIRS) to
      measure changes along cortical pain pathways in the brain related to true and sham dry
      needling treatment.

      Specific Aim #1: The investigators will compare the cortical pain pathway response during dry
      needling treatment to sham dry needling treatment using NIRS in two groups of patients with
      chronic shoulder pain.

      The investigators hypothesize that decreased cortical activity will be seen in the
      dorsolateral prefrontal cortex (DLPFC) in those treated with true dry needling compared to
      those treated with sham dry needling.

      Specific Aim #2: The investigators will evaluate whether the cortical pain pathway response
      (imaged using NIRS) during dry needling predicts 1-week improvement in shoulder muscle
      response, local hypoalgesia, and self-reported pain and disability in the group of patients
      that received true dry needling treatment. The investigators hypothesize that decreased
      cortical activity in the DLPFC will be associated with improvements in shoulder muscle
      response, local hypoalgesia, and self-reported pain and disability in those treated with true
      dry needling.
    

Intervention name(s): Dry Needling; Sham Dry Needling
Intervention type(s): Device; Other
Intervention description(s): The participant will undergo true or sham dry needling treatment with simultaneous monitoring using the NIRS head cap.; The participant randomized to the "sham" group will undergo placebo dry needling which is functionally mimicking trigger point dry needling
Other intervention name(s): Trigger point dry needling; functional dry needling; Placebo Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study will be a randomized controlled trial. A convenience sample will be recruited from the Army Medical Department Center and School and the Brooke Army Medical Center (BAMC) Outpatient Physical Therapy Clinic using fliers and word of mouth. A computer-generated table of random numbers will be used to accomplish the group assignment. Thirty participants with shoulder pain will be randomized to receive either true or sham dry needling (Aim #1). An additional 15 participants will be recruited to receive true dry needling (Aim #2). Pre- and post-treatment and 1-week follow-up measurements will be recorded using the MyotonPRO and NIRS, in addition to measures of local hypoalgesia and self-reported pain and disability.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Pain; Musculoskeletal Injury; Functional near-infrared spectroscopy; Structural health monitoring; Dry needling