Blue Light Device for Pain Therapy
Condition: Low Back Pain; Low Back Pain, Recurrent; Musculoskeletal Pain; Chronic Pain
MeSH terms: Musculoskeletal Pain; Back Pain; Low Back Pain; Chronic Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if the Pain Relief Patch, which shines light of a
      limited wavelength on the painful area of the back, relieves chronic musculoskeletal back
      pain. At the same time, this study will gather information on side effects associated with
      use of the Pain Relief Patch. The study will compare the Pain Relief Patch to a patch that is
      similar in appearance, but which shines a different, presumed nontherapeutic, wavelength of
      light.
    

Detailed description: 
      This study will test the Pain Relief Patch (PRP), a new device containing LEDs that is to be
      worn on the skin of the painful area, to see if it is effective in relieving chronic
      musculoskeletal back pain. It will also test the safety of the patch. The LEDs in the PRP
      emit a certain kind of light (peak wavelength 453 nm) that stimulates the production of
      nitric oxide (NO) in the skin. NO has been shown to induce a number of actions that should
      contribute to pain relief, including relaxation of smooth muscle cells, dilation of blood
      vessels, increased concentrations of oxygen in the cells and washout of metabolic byproducts
      and toxins caused by cell injury or death. Participants in one treatment group will be
      treated 5 times over 2 weeks for 30 minutes with PRP patches in the clinic. Participants in
      the control arm will be treated for the same length of time with a similar device that
      contains LEDs that emit another wavelength of light that does not induce production of NO. To
      prevent the influence of expectations on the results, neither the participants nor the
      medical staff directly responsible for their treatment will be told with which of the test
      patches the participants are treated. Other clinic staff will be responsible for all
      activities that could identify treatment arm, including putting the devices on and removing
      them, and examining the condition of the participants' skin before and after treatment. To
      get an accurate measure of how effective the devices are, participants will score their pain
      several times before the treatment period begins, as well as before and after each treatment.
      They will also complete several pain questionnaires during the study.
    

Intervention name(s): Pain Relief Patch; Control PRP device
Intervention type(s): Device; Device
Intervention description(s): The Pain Relief Patch is a non CE-marked device that is worn on the painful area of the back, where it shines light (453 ± 7 nm, maximum 42 ± 6 mW/cm2 and average 20 ± 1 mW/cm²). It will be used 5 times over 14 days for 30 minutes each time.; The Control PRP device is also a non CE-marked device. It is similar in appearance to the active Pain Relief Patch, except that it shines light of a different wavelength(531 ± 7 nm, maximum 0.4 ± 0.1 mW/cm² and average 0.2 ± 0.05 mW/cm²) for just 5 seconds before it turns off. Participants in the control arm will be treated with the control PRP device 5 times over 14 days for 30 minutes each time.
Other intervention name(s): Blue light device, PRP patch, LED patch
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Musculoskeletal pain; Back pain; Chronic pain