Electrical Stimulus Therapy for Chronic Phantom Limb Pain
Condition: Phantom Limb Pain
MeSH terms: Phantom Limb
Study type: Interventional

Summary: 
      The goal of this pilot study is to assess the effectiveness of an electrical stimulation
      therapy option for the treatment of chronic phantom limb pain in upper or lower limb
      amputees. This therapy has been previously used for sports and joint injuries and is marketed
      for relaxation of muscle spasms, re-education of muscle action, prevention of disuse atrophy,
      increased local blood circulation, and maintaining or increasing range of motion. The
      investigators would like to explore the idea that physically exercising the muscles of the
      residual limb and increasing blood flow to the site of amputation through the promotion of
      motor contraction using electrical stimulation decreases chronic phantom limb pain.
    

Detailed description: 
      There are a large number of people living with an amputation due mainly to cardiovascular
      disease, diabetes, and trauma; and of these there is evidence to show that up to 80% of
      amputees experience phantom limb pain (PLP). PLP is classified as cramping, burning,
      shooting, or stabbing pain in the missing limb following an amputation. Current treatments
      include pharmacological drugs, anesthesia, additional surgery, mirror therapy, transcutaneous
      electrical nerve stimulation (TENS) and others. TENS, as usually implemented, has been used
      to effectively reduce pain in multiple spots of the body, but has shown little effect in
      reducing phantom limb pain especially long term even with varying the frequency and intensity
      of the electrical stimulation. These current treatments can be invasive, costly, and have
      shown only to offer immediate relief. Using an electrical stimulator at a higher intensity
      has proven to to reduce pain and increase healing in numerous sports and joint related
      injuries. Anecdotally, the investigators have learned that a similar treatment protocol when
      applied to persons with phantom limb pain can mitigate their pain. The goal of this pilot
      study is to assess the effectiveness of higher intensity electrical stimulation in the
      management of PLP and also to acquire data to inform the investigators to the most
      appropriate study design and power for a future more formal clinical trial. To accomplish
      this the investigators will utilize the ACP Omnistim FX2 Pro electrical stimulator, that has
      been provided to us by Accelerated Care Plus (ACP) Corporation, to physically exercise the
      muscles of the residual limb and hence increase the local blood flow and explore it's
      potential for treatment of PLP both short and long term. The self-identified subject will be
      hooked up to the ACP electrical stimulator using surface electrodes that will pass a current
      through the skin first at a low intensity for 5 minutes to allow the subject to adjust to the
      tingling sensation. The current will then be gradually increased to a level sufficient to
      elicit a non-painful motor contraction for 15 minutes. Using a numerical pain scale and short
      answer questions about the characteristics of the pain the investigators will track both
      short term and long term changes in pain.
    

Intervention name(s): Experimental Electrical Stimulation Regimen
Intervention type(s): Device
Intervention description(s): The electrodes will pass an electrical current through the skin and into the muscle first at a low intensity for 5 minutes to allow the subject to adjust to the sensation. The current will then be gradually increased to a level sufficient to elicit a non-painful motor contraction. The subject will sit in a relaxed position as the electrical stimulator contracts the muscles for a duration of 15 minutes.
Other intervention name(s): Device: Omnistim FX2 Pro
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility