Blue Light Device for Pain Therapy (PAINCT02)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Light and Health Venture
ClinicalTrials.gov Identifier:
NCT01528332
First received: February 1, 2012
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Low Back Pain
Low Back Pain, Recurrent
Musculoskeletal Pain
Chronic Pain
Device: Pain Relief Patch
Device: Control PRP device
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Light and Health Venture:

Primary Outcome Measures:
  • Change From Baseline (Mean of Three Measurements at Screening, Prior to Treatment Visit 1 and Treatment Visit 1 Pretreatment) in the Average Visual Analog Scale (VAS) Pain Intensity Over the 5 Treatment Days [ Time Frame: Baseline (Visit 1/day -7, at home and Visit 2/day +1), Treatment (Visits 2-6 post treatment/days +1 to +14) ] [ Designated as safety issue: No ]
    Pain intensity scored on a 10.0 cm VAS with the endpoints 0 = no pain; 10 = worst pain imaginable


Secondary Outcome Measures:
  • Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) at Visit 5 [ Time Frame: Baseline (days -7 to +1) to Treatment 5 (day +14) ] [ Designated as safety issue: No ]
    The RMDQ is a 24 list of yes/no questions about the effects of back pain on the participants daily activities. Each positive answer is a point; maximum total score = 24.

  • Change From Baseline in VAS Pain Intensity at Follow up [ Time Frame: Baseline (day -7 to 1) to Follow-up (up to day +42) ] [ Designated as safety issue: No ]
  • Change From Treatment in VAS Pain Intensity at Follow up [ Time Frame: Treatment (day +1 to +14) to Follow-up (up to day +42) ] [ Designated as safety issue: No ]
  • Change From Baseline in RMDQ at Follow up [ Time Frame: Baseline (days -7 to +1) to Follow-up (up to day +42) ] [ Designated as safety issue: No ]
  • Change From Treatment in RMDQ at Follow up [ Time Frame: Treatment (days +1 to +14) to Follow up (up to day +42) ] [ Designated as safety issue: No ]
  • Frequency, Severity, Nature and Duration of Adverse Events During the Whole Duration of the Study [ Time Frame: Baseline (days -7 to -1) to Follow up (up to day +42) ] [ Designated as safety issue: Yes ]
    Adverse events will be assessed using descriptive statistical methods and compared between treatment arms.

  • Vital Sign Parameters [ Time Frame: Baseline (days -7 to -1) to Follow up (up to day +42) ] [ Designated as safety issue: Yes ]
    Vital signs (blood pressure and pulse)will be assessed at each visit and changes from baseline compared between the treatment groups

  • Changes From Baseline in Skin Condition [ Time Frame: Baseline (days -7 to -1) to Follow up (up to day +42) ] [ Designated as safety issue: Yes ]
    Skin condition (erythema and hyperpigmentation as measured with the MX-18) and appearance (recorded with Polaroid photos) will be assessed once each at baseline and follow up, and before and after each treatment. The changes from baseline will be analysed using descriptive statistics and the two treatment arms compared.

  • Average Visual Analog Scale Pain Relief Over 5 Treatments [ Time Frame: 5 treatments (days +1 to +14) ] [ Designated as safety issue: No ]
    The average pain relief scored on a 10.0 cm VAS pain relief scale (endpoints 0 = no pain, 10 = no relief


Enrollment: 171
Study Start Date: February 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pain Relief Patch
Pain Relief Patch: Light wavelength 453 ± 7 nm, maximum 42 ± 6 mW/cm2 and average 20 ± 1 mW/cm², 30 minutes
Device: Pain Relief Patch
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.
Other Name: Blue light device, PRP patch, LED patch
Active Comparator: Control PRP device
Control PRP device: Light wavelength 531 ± 7 nm, maximum 0.4 ± 0.1 mW/cm² and average 0.2 ± 0.05 mW/cm², light on for 5 seconds, device worn for 30 minutes
Device: Control PRP device
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01528332

Locations
Germany
Pain Therapy Section, Dept of Orthopedic Surgery and Traumatology, University Hosp Heidelberg
Heidelberg, Germany
Clinic for Anaesthesiology and Supra-regional Center of Pain Therapy and Palliative Care, University Hosp Heidelberg
Heidelberg, Germany
University Medical Care Center Mannheim, Dept of Anaesthesiology and Surgical Care Medicine
Mannheim, Germany
Sponsors and Collaborators
Light and Health Venture
Investigators
Principal Investigator: Hubert Bardenheuer, Prof. Dr. Clinic for Anaesthesiology and Supra-regional Centre of Pain Therapy and Palliative Care, University Hosp Heidelberg
  More Information

No publications provided

Responsible Party: Light and Health Venture
ClinicalTrials.gov Identifier: NCT01528332     History of Changes
Other Study ID Numbers: PAINCT02
Study First Received: February 1, 2012
Results First Received: September 9, 2013
Last Updated: February 7, 2014
Health Authority: Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Light and Health Venture:
Musculoskeletal pain
Back pain
Chronic pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Musculoskeletal Pain
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 20, 2014