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
Intervention: Pain Relief Patch; Control PRP device
Intervention description: 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.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 171.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Musculoskeletal pain; Back pain; Chronic pain

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is between 18 and 65 years of age, inclusive

          -  Is able to consent to participation by signing the informed consent form

          -  Has had localized mild to moderate (a score ≥ 2 and ≤ 6 on a 0 - 10 point pain
             intensity VAS) back pain for the 3 months prior to enrollment in study or longer

          -  Has a mean pain intensity VAS value (calculated from pain intensity VAS at Screening
             Visit, home assessment and pretreatment at Visit 1) between ≥ 2 and ≤6 at baseline
             prior to randomization

          -  Has skin type II, III or IV on the Fitzpatrick skin type scale (Types I - VI)

          -  Is willing and able to adhere to all study requirements, including accurate completion
             of VAS and questionnaires at the required time points, and is willing and able to
             travel to investigator's site to attend all required visits

          -  Is able to understand the study plan, its conditions, the therapy goals and expected
             outcomes

        Exclusion Criteria:To be eligible for inclusion into this study, the patient must not meet
        any of the following criteria prior to enrollment:

        General:

          -  Is participating in another clinical study at time of this study, or has participated
             in another study within the 30 days prior to signing the informed consent form

          -  Is pregnant or breast-feeding

          -  Is a sexually active female of childbearing potential and is not using a medically
             approved form of contraception

          -  Has moderate or severe arterial hypertension (WHO/ISH grade 2 or higher; systolic BP ≥
             160 and/or a diastolic BP ≥ 100), a history of stroke, myocardial infarction, angina
             pectoris, arteriosclerotic vascular disease (ASVD), or peripheral vascular disease, or
             (severe) congestive heart failure

          -  Is in poor general health

          -  Is an employee of the investigational site directly affiliated with this study and/or
             their immediate family members; an employee of the sponsor or the CRO

        Back Pain Related:

          -  Has had any failed back surgery, or has had any surgery to torso, head or back within
             the previous 8 weeks

          -  Had an acute dislocation or fracture within the previous 8 weeks

          -  Has a degenerative central nervous system disease such as Multiple Sclerosis or
             Parkinson's disease; or a spinal stenosis that contributes to or is the cause of back
             pain; or Cauda equina syndrome, or other neurological symptoms indicating neuropathy

          -  Has any sensory deprivation or diagnosis of shingles or postherpetic neuralgia
             (specifically in mid-trunk region)

          -  Has wide spread pain

          -  Has any inflammatory disease that causes pain or any other chronic disease or
             infection known to cause pain (e.g. spondyloarthropathy, rheumatoid arthritis, Lupus
             erythematodes, Lyme borreliosis, etc.)

          -  Has schizophrenia, borderline syndrome or severe depression

          -  Has or has had cancer

          -  Has a history of severe osteoporosis (T score of 2.5 and a history of 1 or more bone
             fractures), or another severe bone disease

          -  Is unwilling to abstain from other non-drug back pain treatments, such as massage,
             sauna, transcutaneous electrical nerve stimulation, etc., for the duration of the
             trial

          -  Is unwilling to abstain from use of pain medication other than those recommended on
             steps 1 and 2 of the WHO Analgesic Ladder for the duration of the trial

        Treatment Related:

          -  Has a known sun allergy, or known allergy to any device related material

          -  Uses steroids or any photosensitizing medication

          -  Has any known disease or idiopathic dermatosis such as porphyria, polymorphic light
             eruption, chronic actinic dermatitis, actinic prurigo or solar urticaria that causes
             photosensitivity

          -  Has a skin pathology, tattoo etc., or skin disease such as local infection, psoriasis,
             eczema etc. in the treatment area

          -  Has any anatomical pathology or other limitation that would prevent successful
             placement of the device

          -  Has an implanted medical device (screw, etc.) in or near the treatment area or an
             active implantable medical device such as cardiac pacemaker, defibrillator,
             neurostimulator, cochlear implant, active drug administration device anywhere in the
             body

          -  Is unwilling to abstain from sunbathing or use of tanning lights for the duration of
             the trial

          -  Is in the process of seeking early retirement, or is engaged in outstanding litigation
             involving back pain