Trial Outcomes & Findings for Blue Light Device for Pain Therapy (NCT NCT01528332)

Results Overview

Pain intensity scored on a 10.0 cm VAS with the endpoints 0 = no pain; 10 = worst pain imaginable

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

171 participants

Primary outcome timeframe

Baseline (Visit 1/day -7, at home and Visit 2/day +1), Treatment (Visits 2-6 post treatment/days +1 to +14)

Results posted on

2014-03-12

Participant Flow

Date of First Enrollment: 03-Feb-2012 Date of Last Patient Last Visit: 03-Jul-2012

Participant milestones

Participant milestones
Measure	Pain Relief Patch Pain Relief Patch: Light wavelength 453 ± 7 nm, maximum 42 ± 6 mW/cm2 and average 20 ± 1 mW/cm², 30 minutes	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
Overall Study STARTED	85	86
Overall Study COMPLETED	81	84
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Blue Light Device for Pain Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pain Relief Patch n=85 Participants Pain Relief Patch: Light wavelength 453 ± 7 nm, maximum 42 ± 6 mW/cm2 and average 20 ± 1 mW/cm², 30 minutes	Control PRP Device n=86 Participants 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	Total n=171 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	85 Participants n=5 Participants	86 Participants n=7 Participants	171 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	50.0 years STANDARD_DEVIATION 10.7 • n=5 Participants	51.4 years STANDARD_DEVIATION 8.3 • n=7 Participants	50.7 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants	58 Participants n=7 Participants	113 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	28 Participants n=7 Participants	58 Participants n=5 Participants
Region of Enrollment Germany	85 participants n=5 Participants	86 participants n=7 Participants	171 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Pain Relief Patch n=85 Participants Pain Relief Patch: Light wavelength 453 ± 7 nm, maximum 42 ± 6 mW/cm2 and average 20 ± 1 mW/cm², 30 minutes	Control PRP Device n=86 Participants 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
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	-0.87 cm Standard Error 0.11

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (day -7 to 1) to Follow-up (up to day +42)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment (day +1 to +14) to Follow-up (up to day +42)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (days -7 to +1) to Follow-up (up to day +42)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment (days +1 to +14) to Follow up (up to day +42)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

Adverse Events

Pain Relief Patch

Serious events: 0 serious events

Other events: 62 other events

Deaths: 0 deaths

Control PRP Device

Serious events: 0 serious events

Other events: 60 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Pain Relief Patch n=85 participants at risk Pain Relief Patch: Light wavelength 453 ± 7 nm, maximum 42 ± 6 mW/cm2 and average 20 ± 1 mW/cm², 30 minutes	Control PRP Device n=86 participants at risk 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
Nervous system disorders Headache	31.8% 27/85 • 6 months	34.9% 30/86 • 6 months
Musculoskeletal and connective tissue disorders Arthralgia	7.1% 6/85 • 6 months	1.2% 1/86 • 6 months
General disorders General Disorders	20.0% 17/85 • 6 months	14.0% 12/86 • 6 months
Gastrointestinal disorders Gastrointestinal disorders	12.9% 11/85 • 6 months	17.4% 15/86 • 6 months
Infections and infestations Infections and Infestations	5.9% 5/85 • 6 months	11.6% 10/86 • 6 months
Ear and labyrinth disorders Ear and labyrinth disorders	5.9% 5/85 • 6 months	4.7% 4/86 • 6 months
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	2.4% 2/85 • 6 months	7.0% 6/86 • 6 months
Psychiatric disorders Psychiatric disorders	1.2% 1/85 • 6 months	7.0% 6/86 • 6 months
Musculoskeletal and connective tissue disorders Back Pain	4.7% 4/85 • 6 months	5.8% 5/86 • 6 months

Additional Information

Dr. Elke Naujokat

Philips Consumer Lifestyle

Phone: +31 (0) 631974213

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place