Low Back PainPhase 3PAINCT02NCT01528332
Blue Light Device for Pain Therapy
A Phase 3 study testing Pain Relief Patch in people with Low Back Pain and Low Back Pain, Recurrent, run by Philips Electronics Nederland BV at 3 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain, Low Back Pain, Recurrent, Musculoskeletal Pain
- What is being tested?
- Pain Relief Patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 3 sitesGermany
- Study dates
- Feb 2012to Aug 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 36Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Clinic for Anaesthesiology and Supra-regional Center of Pain Therapy and Palliative Care, University Hosp Heidelberg
Heidelberg
Pain Therapy Section, Dept of Orthopedic Surgery and Traumatology, University Hosp Heidelberg
Heidelberg
University Medical Care Center Mannheim, Dept of Anaesthesiology and Surgical Care Medicine
Mannheim
About this study
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
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.
Read the 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.
- Being tested
- Pain Relief Patch, Control PRP device
- Keywords
- Musculoskeletal pain, Back pain, Chronic pain
- Medical subject headings
- Low Back Pain, Musculoskeletal Pain, Chronic Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Relief PatchDevice
Also called Blue light device, PRP patch, LED 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.
Control PRP deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Pain Relief Patch | Experimental | Pain Relief Patch: Light wavelength 453 ± 7 nm, maximum 42 ± 6 mW/cm2 and average 20 ± 1 mW/cm², 30 minutes Receives: Device: Pain Relief Patch |
| Control PRP device | Active comparator | 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 Receives: Device: Control PRP device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (Visit 1/day -7, at home and Visit 2/day +1), Treatment (Visits 2-6 post treatment/days +1 to +14)
Secondary outcomes (9)
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.
Measured: Baseline (days -7 to +1) to Treatment 5 (day +14)
Change From Baseline in VAS Pain Intensity at Follow up
Measured: Baseline (day -7 to 1) to Follow-up (up to day +42)
Change From Treatment in VAS Pain Intensity at Follow up
Measured: Treatment (day +1 to +14) to Follow-up (up to day +42)
Change From Baseline in RMDQ at Follow up
Measured: Baseline (days -7 to +1) to Follow-up (up to day +42)
Change From Treatment in RMDQ at Follow up
Measured: 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
Adverse events will be assessed using descriptive statistical methods and compared between treatment arms.
Measured: Baseline (days -7 to -1) to Follow up (up to day +42)
Vital Sign Parameters
Vital signs (blood pressure and pulse)will be assessed at each visit and changes from baseline compared between the treatment groups
Measured: Baseline (days -7 to -1) to Follow up (up to day +42)
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.
Measured: Baseline (days -7 to -1) to Follow up (up to day +42)
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
Measured: 5 treatments (days +1 to +14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Electronics Nederland BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hubert Bardenheuer, Prof. Dr., Principal investigator, Clinic for Anaesthesiology and Supra-regional Centre of Pain Therapy and Palliative Care, University Hosp Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01528332
- Sponsor's protocol ID
- PAINCT02
- Acronym
- PAINCT02
- Status last verified
- Feb 2014
- First submitted
- 1 Feb 2012
- Last updated
- 12 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Baron R, Morlion B, Dahan A, Uberall M, von Basum G, Wild I. A prospective, randomized, controlled, double-blind, multi-center study to evaluate the efficacy and safety of a blue light device for the treatment of chronic back pain. Front Pain Res (Lausanne). 2024 Jul 23;5:1444401. doi: 10.3389/fpain.2024.1444401. eCollection 2024.
PubMed 39109241
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01528332
- Acronym / sponsor ID
- PAINCT02 / PAINCT02
- Keywords
- Musculoskeletal pain, Back pain, Chronic pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Philips Electronics Nederland BVIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 8 Feb 2012 (estimated)
- Results
- Posted 8 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain Relief Patch | Experimental | Device: Pain Relief PatchPain Relief Patch: Light wavelength 453 ± 7 nm, maximum 42 ± 6 mW/cm2 and average 20 ± 1 mW/cm², 30 minutes |
| Control PRP device | Active comparator | Device: Control PRP deviceControl 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (36 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain Relief PatchAlso: Blue light device, PRP patch, LED patchThe 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. | Device | Pain Relief Patch |
| Control PRP deviceThe 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. | Device | Control PRP device |
Primary outcome
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
9 secondary outcomes
Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) at Visit 5
Time frame: 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)
Change From Treatment in VAS Pain Intensity at Follow up
Time frame: 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)
Change From Treatment in RMDQ at Follow up
Time frame: 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)
Vital Sign Parameters
Time frame: 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)
Average Visual Analog Scale Pain Relief Over 5 Treatments
Time frame: 5 treatments (days +1 to +14)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39109241Baron R, Morlion B, Dahan A, Uberall M, von Basum G, Wild I. A prospective, randomized, controlled, double-blind, multi-center study to evaluate the efficacy and safety of a blue light device for the treatment of chronic back pain. Front Pain Res (Lausanne). 2024 Jul 23;5:1444401. doi: 10.3389/fpain.2024.1444401. eCollection 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hubert Bardenheuer, Prof. Dr. principal investigator
Clinic for Anaesthesiology and Supra-regional Centre of Pain Therapy and Palliative Care, University Hosp Heidelberg
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pain Relief Patch in people with Low Back Pain and Low Back Pain, Recurrent, run by Philips Electronics Nederland BV at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 36 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01528332, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2014.