Blue Light Device for Pain Therapy (PAINCT02)

February 7, 2014 updated by: Philips Electronics Nederland BV

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
171

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany
        • Clinic for Anaesthesiology and Supra-regional Center of Pain Therapy and Palliative Care, University Hosp Heidelberg
      • Heidelberg, Germany
        • Pain Therapy Section, Dept of Orthopedic Surgery and Traumatology, University Hosp Heidelberg
      • Mannheim, Germany
        • University Medical Care Center Mannheim, Dept of Anaesthesiology and Surgical Care Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Pain intensity scored on a 10.0 cm VAS with the endpoints 0 = no pain; 10 = worst pain imaginable
Baseline (Visit 1/day -7, at home and Visit 2/day +1), Treatment (Visits 2-6 post treatment/days +1 to +14)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) at Visit 5
Time Frame: Baseline (days -7 to +1) to Treatment 5 (day +14)
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.
Baseline (days -7 to +1) to Treatment 5 (day +14)
Change From Baseline in VAS Pain Intensity at Follow up
Time Frame: Baseline (day -7 to 1) to Follow-up (up to day +42)
Baseline (day -7 to 1) to Follow-up (up to day +42)
Change From Treatment in VAS Pain Intensity at Follow up
Time Frame: Treatment (day +1 to +14) to Follow-up (up to day +42)
Treatment (day +1 to +14) to Follow-up (up to day +42)
Change From Baseline in RMDQ at Follow up
Time Frame: Baseline (days -7 to +1) to Follow-up (up to day +42)
Baseline (days -7 to +1) to Follow-up (up to day +42)
Change From Treatment in RMDQ at Follow up
Time Frame: Treatment (days +1 to +14) to Follow up (up to day +42)
Treatment (days +1 to +14) to Follow up (up to day +42)
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)
Adverse events will be assessed using descriptive statistical methods and compared between treatment arms.
Baseline (days -7 to -1) to Follow up (up to day +42)
Vital Sign Parameters
Time Frame: Baseline (days -7 to -1) to Follow up (up to day +42)
Vital signs (blood pressure and pulse)will be assessed at each visit and changes from baseline compared between the treatment groups
Baseline (days -7 to -1) to Follow up (up to day +42)
Changes From Baseline in Skin Condition
Time Frame: Baseline (days -7 to -1) to Follow up (up to day +42)
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.
Baseline (days -7 to -1) to Follow up (up to day +42)
Average Visual Analog Scale Pain Relief Over 5 Treatments
Time Frame: 5 treatments (days +1 to +14)
The average pain relief scored on a 10.0 cm VAS pain relief scale (endpoints 0 = no pain, 10 = no relief
5 treatments (days +1 to +14)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Philips Electronics Nederland BV

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hubert Bardenheuer, Prof. Dr., Clinic for Anaesthesiology and Supra-regional Centre of Pain Therapy and Palliative Care, University Hosp Heidelberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PAINCT02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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