Trial Outcomes & Findings for Study of Low Level Laser Therapy to Treat Chronic Heel Pain Arising From Plantar Fasciitis (NCT NCT01835743)

Last Updated: 2014-06-03

Results Overview

Each subject rated heel pain upon taking the first few steps of the day on the 0-100 mm (0 -10 cm) Visual Analog Pain Scale (VAS) from '0: no pain at all' to '100: worst pain imaginable'. The higher the VAS score, the greater the heel pain experienced. Percent (%) change in VAS score was calculated as the % difference in VAS score at week 5 (2 weeks after procedure administration end) relative to baseline evaluation. A negative (-) % difference in VAS score across the evaluation period indicated a decrease (improvement) in heel pain, and a positive (+) % difference in VAS score indicated an increase (worsening) in heel pain. A change of -30% or greater in the VAS score was considered positive for study success. The number of participants who attained a change of -30% of greater in VAS score across the evaluation period was calculated for both subjects in the test group and in th placebo group as a proportion of the total number of subjects in each procedure group.

Recruitment status

COMPLETED

Study phase

Target enrollment

69 participants

Primary outcome timeframe

baseline and 5 weeks

Results posted on

2014-06-03

Participant Flow

Participant milestones

Participant milestones
Measure	Erchonia HPS Laser The Erchonia HPS Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light. Erchonia HPS Laser: The Erchonia HPS Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration.	Placebo Laser The Placebo Laser is identical in appearance and operation to the Erchonia HPS Laser but does not emit any therapeutic light. Placebo Laser: The Placebo Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration.
Overall Study STARTED	37	32
Overall Study COMPLETED	37	32
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Low Level Laser Therapy to Treat Chronic Heel Pain Arising From Plantar Fasciitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Erchonia HPS Laser n=37 Participants The Erchonia HPS Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light. Erchonia HPS Laser: The Erchonia HPS Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration.	Placebo Laser n=32 Participants The Placebo Laser is identical in appearance and operation to the Erchonia HPS Laser but does not emit any therapeutic light. Placebo Laser: The Placebo Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration.	Total n=69 Participants Total of all reporting groups
Age, Continuous	56.70 years STANDARD_DEVIATION 10.46 • n=5 Participants	55.81 years STANDARD_DEVIATION 12.33 • n=7 Participants	56.29 years STANDARD_DEVIATION 11.29 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	18 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	34 Participants n=5 Participants	29 Participants n=7 Participants	63 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	37 participants n=5 Participants	32 participants n=7 Participants	69 participants n=5 Participants
Heel Side Right Heel	20 participants n=5 Participants	9 participants n=7 Participants	29 participants n=5 Participants
Heel Side Left Heel	17 participants n=5 Participants	23 participants n=7 Participants	40 participants n=5 Participants
Duration of Heel Pain at Baseline	12.34 months STANDARD_DEVIATION 11.08 • n=5 Participants	12.23 months STANDARD_DEVIATION 12.41 • n=7 Participants	12.29 months STANDARD_DEVIATION 11.63 • n=5 Participants
Degree of Heel Pain at Baseline	69.15 units on a scale STANDARD_DEVIATION 12.65 • n=5 Participants	67.70 units on a scale STANDARD_DEVIATION 11.80 • n=7 Participants	68.48 units on a scale STANDARD_DEVIATION 12.19 • n=5 Participants

PRIMARY outcome

Timeframe: baseline and 5 weeks

Outcome measures

Outcome measures
Measure	Erchonia HPS Laser n=37 Participants The Erchonia HPS Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light. Erchonia HPS Laser: The Erchonia HPS Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration.	Placebo Laser n=32 Participants The Placebo Laser is identical in appearance and operation to the Erchonia HPS Laser but does not emit any therapeutic light. Placebo Laser: The Placebo Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration.
Number of Participants Who Attained a Change of -30% or Greater in the VAS Score	23 participants	4 participants

SECONDARY outcome

Timeframe: baseline and 5 weeks

Each subject rated heel pain upon taking the first few steps of the day on the 0-100 mm (0 -10 cm) Visual Analog Pain Scale (VAS) from '0: no pain at all' to '100: worst pain imaginable'. The higher the VAS score, the greater the heel pain experienced. Change in heel pain score on the VAS was calculated as the heel pain VAS score at week 5 (2 weeks after procedure administration end) minus the heel pain VAS score at baseline evaluation. A negative (-) change in heel pain VAS score across the evaluation period indicated a decrease (improvement) in heel pain and was positive for study success. A positive (+) change in heel pain VAS score indicated an increase (worsening) in heel pain and was negative for study success.

Outcome measures

Outcome measures
Measure	Erchonia HPS Laser n=37 Participants The Erchonia HPS Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light. Erchonia HPS Laser: The Erchonia HPS Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration.	Placebo Laser n=32 Participants The Placebo Laser is identical in appearance and operation to the Erchonia HPS Laser but does not emit any therapeutic light. Placebo Laser: The Placebo Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration.
Change in Heel Pain Score on the Visual Analog Scale (VAS)	-29.47 scores on a 0-100 VAS scale Standard Deviation 24.94	-5.38 scores on a 0-100 VAS scale Standard Deviation 16.01

Adverse Events

Erchonia HPS Laser

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Laser

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Coughlin, MD

Coughlin Foot and Ankle Clinic

Phone: 208-367-3330

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place