Efficacy of the InterX 5000 in the Treatment of Chronic Neck Pain
Condition: Neck Pain; Shoulder Pain
MeSH terms: Shoulder Pain; Neck Pain
Study type: Interventional

Summary: 
      This study will focus on the efficacy of treating 80 patients who have functional limitations
      in activity because of chronic/recurrent neck or shoulder pain.

      Hypothesis 1: InterX therapy alone will have a moderate effect to reduce pain during weeks
      1-2.

      Hypothesis 2: Functional gains will be greater in patients receiving InterX therapy compared
      to those who received placebo treatment.

      Hypothesis 3: Chronic neck and shoulder pain is more prevalent in patients who exhibit
      radiographic evidence of degenerative spondylosis/arthrosis of the cervical spine.
    

Detailed description: 
      Evaluation of subjects will be conducted at baseline (interval 0) and at 2, 4, 6 and 12 week
      time periods. At 26 weeks, the patient will be contacted to obtain follow-up questionnaires
      on pain and function. After informed consent, participants will be randomly assigned to a
      treatment group and a sham group using the InterX5002, hand held electrical stimulation unit.
      Treatment will be administered three times per week for six weeks.

      During the interval of weeks 1-2 patients will have either the InterX treatment/sham alone.
      Weeks 3-4 will advance the patient adding a standardized rehabilitation exercise program
      typical for chronic neck patients. During weeks 5-6, the patient will be scheduled for
      treatment and will use a self-administered InterX treatment ("home" Flex) unit mimicking home
      care but accounting for compliance issues through attendance being monitored.

      Baseline and follow-up assessments will consist of pain scores, NDI, neck fatigue testing,
      shoulder and arm reach tasks and walking on a treadmill at 2 MPH for 5 minutes (Neck-walk
      Index, NWI). Neck fatigue testing will consist of prone positioning and extensor muscle
      exertion against resistance to tolerance at 60% MVC. Myoelectric sensors will be taped to the
      skin to record muscle activity during fatigue and reach task testing. Electromagnetic sensors
      will be taped to a swimmers cap worn by the patient and on the skin at T1 over the spine at
      the shoulder level and S1 at the pelvis during the walk on the treadmill and on the shoulder
      and arm during reach testing.

      Venipuncture will be performed at the evaluation intervals to collect blood samples for
      quantifying circulating inflammatory cytokines.

      Analysis will focus on change in pain scores and inflammatory cytokines over the first two
      weeks for Hypothesis H1. Primary functional outcomes including neck fatigue and progression
      through neck rehabilitation exercise will be tested for Hypothesis2. The third hypothesis
      will be tested in two ways. First, quantification of degenerative changes (e.g.disc narrowing
      & osteophyte formation) on x-ray (AP & Lat screening views) will be contrasted to incidence
      in the published literature. Second, pain levels at baseline will be stratified into
      quartiles and compared to quantitative tally of degenerative changes. This data will serve as
      a basis for determining whether future studies using degenerative change criteria are
      warranted. Myoelectric activity, fatigue and head-pelvic position data will be used
      descriptively to assess functional differences from baseline to completion of treatment.
    

Intervention name(s): InterX 5000; InterX 5000
Intervention type(s): Device; Device
Intervention description(s): A computer driven electrical stimulation unit that contains a cutaneous impedance sensor.; Placebo treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neck; Chronic; Musculoskeletal; Shoulder