Blue Light Device for Pain Therapy (PAINCT02)
|ClinicalTrials.gov Identifier: NCT01528332|
Recruitment Status : Completed
First Posted : February 8, 2012
Results First Posted : January 8, 2014
Last Update Posted : March 12, 2014
|Condition or disease||Intervention/treatment||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 (Clinical Trial)|
|Actual Enrollment :||171 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|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|
|Study Start Date :||February 2012|
|Primary Completion Date :||August 2012|
|Study Completion Date :||August 2012|
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.
- 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
- 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.
- 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) ]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) ]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) ]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) ]The average pain relief scored on a 10.0 cm VAS pain relief scale (endpoints 0 = no pain, 10 = no relief
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01528332
|Clinic for Anaesthesiology and Supra-regional Center of Pain Therapy and Palliative Care, University Hosp Heidelberg|
|Pain Therapy Section, Dept of Orthopedic Surgery and Traumatology, 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|