Blue Light Device for Pain Therapy
CompletedPhase 3NCT01528332
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- A Prospective, Randomized, Controlled, Double-Blind, Multi-Centre Study to Evaluate the Efficacy and Safety of Blue Light Therapy for Relief of Chronic Musculoskeletal Back Pain
- Interventions
- Device: Pain Relief Patch
- Device: Control PRP device
- Sponsor
- Philips Electronics Nederland BV
- Start date
- 2012-02
- Primary completion
- 2012-08
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- Germany
- Total sites listed
- 3
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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 c…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01528332