Blue Light Device for Pain Therapy (PAINCT02)
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.
Low Back Pain
Low Back Pain, Recurrent
Device: Pain Relief Patch
Device: Control PRP device
|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|
- 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
- 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
|Study Start Date:||February 2012|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
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.
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.
|Pain Therapy Section, Dept of Orthopedic Surgery and Traumatology, University Hosp Heidelberg|
|Clinic for Anaesthesiology and Supra-regional Center of Pain Therapy and Palliative Care, University Hosp Heidelberg|
|University Medical Care Center Mannheim, Dept of Anaesthesiology and Surgical Care Medicine|
|Principal Investigator:||Hubert Bardenheuer, Prof. Dr.||Clinic for Anaesthesiology and Supra-regional Centre of Pain Therapy and Palliative Care, University Hosp Heidelberg|