Combining CES Alpha-Stim and InterX for Optimized Rehabilitation Following Extremity Immobilization
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional

Summary: 
      This study will be aimed at assessing the feasibility of a dual-device treatment prior to a
      rehabilitation session for an orthopaedic injury requiring immobilization, and its impact on
      improving outcomes and decreasing the risk for development of neuropathic pain. The
      investigators will evaluate the clinical feasibility and effectiveness of incorporating the
      Alpha-Stim and Inter-X treatment into a standard rehabilitation protocol to address risk
      factors associated with the development of neuropathic pain (i.e., pain, range of motion, and
      skin temperature) as well as its impact on reduced pain medication.
    

Detailed description: 
      Once patients provide consent and we have determined that they meet inclusion criteria the
      process will occur as follows:

        1. Participants will be administered baseline demographic and standard medical history
           questionnaires, including information about prescription medication use. In addition,
           participants will fill out baseline self-report outcomes and be administered the (LANSS)
           Pain Scale. Range of motion and temperature will also be assessed during the initial
           session. Some of these measurements are standard of care and would be filled out by the
           participant even if the participant were not participating in the study.

      Usual CARE The usual care aspect of this study is the delivery of the pain treatment (NIN and
      CES) as is commonly used at the Center for the Intrepid. The experimental aspect is the
      combined delivery of the treatment, and the use of sham treatment as a control. The treatment
      (NIN and CES) will be delivered in a pragmatic fashion, with treatment delivered in
      conjunction with rehab visits and lasting approximately 4-weeks total. Each session will last
      approximately 20-40 minutes long, and will most often be delivered in conjunction with their
      rehab visit (physical therapy or occupational therapy) that occurs anywhere from 1 to 3 times
      each week.

      STRICTLY RESEARCH The experimental aspect of the study will be the comparison of combined
      treatment (NIN + CES), standard NIN with sham CES, to standard care alone. Before initiation
      of treatment participants will be randomized to either NIN + CES, NIN + Sham CES, or standard
      care only immediately after the immobilization device (cast, brace, etc) has been removed.
      Randomization with be performed with a random number gerator. All groups will continue with
      their own rehabilitation as indicated throughout the entire course of the study treatment,
      and beyond as indicated by their therapist. The investigators will keep track of rehab
      appointments and visits, but not control for them.

      3. At the 1-month follow-up, all participants will fill out the same self-report outcome
      measures from baseline, to include prescription pain medication and be administered the LANSS
      pain scale. Range of motion and temperature will also be assessed.

      4. At the 2 and 4-month follow-up the same assessments will again be administered. If the
      participant has completed formal therapy prior to the 2 and 4 month follow-up time points the
      participant will be asked to return to the clinic to complete these assessments. Participants
      may be contacted by telephone or email, if agreeable, to provide a reminder for the return
      appointment(s).

      5. Outcomes will be compared between the three groups at each time point (i.e., initial, one
      month, two months, four months).

      6. All participants will be followed out to 4 months.

      Although every attempt will be made to collect data at these specific times, due to the
      variability of participant and clinic schedules, the actual timing of collection may vary
      (+/- 1 week) and some of the proposed measures may not be collected at all time points.
    

Intervention name(s): NIN; Sham CES; CES
Intervention type(s): Device; Device; Device
Intervention description(s): The InterX device will be applied by a trained therapist along the course of the dermatomes in the affected area, paying special attention to the location of major cutaneous nerves ensuring optimal treatment points are identified and treated within the neurologically related area.; The sham CES is identical to the regular device but ear clips will emit a dose at 100 mA, a sub-sensory level.; Cranial Electrical Stimulation (CES) Alpha-Stim is a noninvasive medical treatment device that delivers a microcurrent (100 to 500 microamperes) via ear clip electrodes connected to a handheld device.
Other intervention name(s): InterX; Alpha-Stim Sham; Alpha-Stim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment