Status:
COMPLETED
Blue Light Device for Pain Therapy
Lead Sponsor:
Philips Electronics Nederland BV
Conditions:
Low Back Pain
Low Back Pain, Recurrent
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 ...
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
171 Patients enrolled
Trial Details
Trial ID
NCT01528332
Start Date
February 1 2012
End Date
August 1 2012
Last Update
March 12 2014
Active Locations (3)
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1
Clinic for Anaesthesiology and Supra-regional Center of Pain Therapy and Palliative Care, University Hosp Heidelberg
Heidelberg, Germany
2
Pain Therapy Section, Dept of Orthopedic Surgery and Traumatology, University Hosp Heidelberg
Heidelberg, Germany
3
University Medical Care Center Mannheim, Dept of Anaesthesiology and Surgical Care Medicine
Mannheim, Germany