Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT01528332
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01528332
Study Brief:
Protocol Section:
NCT01528332