Chronic Pain, Low Back Pain, Low Back Pain, Recurrent, Musculoskeletal Pain
Conditions
Keywords
Musculoskeletal pain, Back pain, Chronic pain
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 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.
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.
Interventions
DEVICEPain 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.
DEVICEControl 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.
Sponsors
Philips Electronics Nederland BV
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in VAS Pain Intensity at Follow up | Baseline (day -7 to 1) to Follow-up (up to day +42) | — |
| Change From Treatment in VAS Pain Intensity at Follow up | Treatment (day +1 to +14) to Follow-up (up to day +42) | — |
| Change From Baseline in RMDQ at Follow up | Baseline (days -7 to +1) to Follow-up (up to day +42) | — |
| Change From Treatment in RMDQ at Follow up | Treatment (days +1 to +14) to Follow up (up to day +42) | — |
| Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) at Visit 5 | 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. |
| Vital Sign Parameters | 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 |
| Changes From Baseline in Skin Condition | 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. |
| Average Visual Analog Scale Pain Relief Over 5 Treatments | 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 |
| Frequency, Severity, Nature and Duration of Adverse Events During the Whole Duration of the Study | 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. |
Countries
Germany
Participant flow
Recruitment details
Date of First Enrollment: 03-Feb-2012 Date of Last Patient Last Visit: 03-Jul-2012
Participants by arm
| Arm | Count |
|---|---|
| Pain Relief Patch Pain Relief Patch: Light wavelength 453 ± 7 nm, maximum 42 ± 6 mW/cm2 and average 20 ± 1 mW/cm², 30 minutes | 85 |
| 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 | 86 |
| Total | 171 |
Baseline characteristics
| Characteristic | Control PRP Device | Pain Relief Patch | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 86 Participants | 85 Participants | 171 Participants |
| Age, Continuous | 51.4 years STANDARD_DEVIATION 8.3 | 50.0 years STANDARD_DEVIATION 10.7 | 50.7 years STANDARD_DEVIATION 9.5 |
| Region of Enrollment Germany | 86 participants | 85 participants | 171 participants |
| Sex: Female, Male Female | 58 Participants | 55 Participants | 113 Participants |
| Sex: Female, Male Male | 28 Participants | 30 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 62 / 85 | 60 / 86 |
| serious Total, serious adverse events | 0 / 85 | 0 / 86 |
Outcome results
Primary
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
Pain intensity scored on a 10.0 cm VAS with the endpoints 0 = no pain; 10 = worst pain imaginable
Time frame: Baseline (Visit 1/day -7, at home and Visit 2/day +1), Treatment (Visits 2-6 post treatment/days +1 to +14)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pain Relief Patch | 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 | -1.24 cm | Standard Error 0.11 |
| Control PRP Device | 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 | -0.87 cm | Standard Error 0.11 |
Secondary
Average Visual Analog Scale Pain Relief Over 5 Treatments
The average pain relief scored on a 10.0 cm VAS pain relief scale (endpoints 0 = no pain, 10 = no relief
Time frame: 5 treatments (days +1 to +14)
Secondary
Change From Baseline in RMDQ at Follow up
Time frame: Baseline (days -7 to +1) to Follow-up (up to day +42)
Secondary
Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) at Visit 5
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.
Time frame: Baseline (days -7 to +1) to Treatment 5 (day +14)
Secondary
Change From Baseline in VAS Pain Intensity at Follow up
Time frame: Baseline (day -7 to 1) to Follow-up (up to day +42)
Secondary
Change From Treatment in RMDQ at Follow up
Time frame: Treatment (days +1 to +14) to Follow up (up to day +42)
Secondary
Change From Treatment in VAS Pain Intensity at Follow up
Time frame: Treatment (day +1 to +14) to Follow-up (up to day +42)
Secondary
Changes From Baseline in Skin Condition
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.
Time frame: Baseline (days -7 to -1) to Follow up (up to day +42)
Secondary
Frequency, Severity, Nature and Duration of Adverse Events During the Whole Duration of the Study
Adverse events will be assessed using descriptive statistical methods and compared between treatment arms.
Time frame: Baseline (days -7 to -1) to Follow up (up to day +42)
Secondary
Vital Sign Parameters
Vital signs (blood pressure and pulse)will be assessed at each visit and changes from baseline compared between the treatment groups
Time frame: Baseline (days -7 to -1) to Follow up (up to day +42)