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Trial record 36 of 2651 for:    ( Map: Idaho, United States )

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

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ClinicalTrials.gov Identifier: NCT01835743
Recruitment Status : Completed
First Posted : April 19, 2013
Results First Posted : June 3, 2014
Last Update Posted : June 3, 2014
Sponsor:
Information provided by (Responsible Party):
Erchonia Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Plantar Fasciitis
Interventions Device: Erchonia HPS Laser
Device: Placebo Laser
Enrollment 69
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Erchonia HPS Laser Placebo Laser
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 37 32
Completed 37 32
Not Completed 0 0
Arm/Group Title Erchonia HPS Laser Placebo Laser Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 37 32 69
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants 32 participants 69 participants
56.70  (10.46) 55.81  (12.33) 56.29  (11.29)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 32 participants 69 participants
Female
24
  64.9%
18
  56.3%
42
  60.9%
Male
13
  35.1%
14
  43.8%
27
  39.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 32 participants 69 participants
Hispanic or Latino
3
   8.1%
3
   9.4%
6
   8.7%
Not Hispanic or Latino
34
  91.9%
29
  90.6%
63
  91.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 37 participants 32 participants 69 participants
37 32 69
Heel Side   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 37 participants 32 participants 69 participants
Right Heel 20 9 29
Left Heel 17 23 40
[1]
Measure Description: Heel side (right heel or left heel) that qualified for and received the study procedure administrations
Duration of Heel Pain at Baseline   [1] 
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 37 participants 32 participants 69 participants
12.34  (11.08) 12.23  (12.41) 12.29  (11.63)
[1]
Measure Description: The duration of heel pain at baseline was recorded as subject reported length of experiencing heel pain to that timepoint, in months.
Degree of Heel Pain at Baseline   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 37 participants 32 participants 69 participants
69.15  (12.65) 67.70  (11.80) 68.48  (12.19)
[1]
Measure Description: Subjects rated the overall degree of pain experienced in the heel region of the heel being treated and evaluated in the study upon waking in the morning and taking the first few steps of the day for 2 consecutive days before receiving the first study procedure with the Erchonia HPS. The degree of pain was recorded by placing a cross along the point that best represented their current heel pain level on the 0-100 mm (0 -10 cm) Visual Analog Pain Scale (VAS) ranging from ‘0: no pain at all’ to ‘100: worst pain imaginable,’. The higher the rating, the greater the heel pain experienced.
1.Primary Outcome
Title Number of Participants Who Attained a Change of -30% or Greater in the VAS Score
Hide Description 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.
Time Frame baseline and 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erchonia HPS Laser Placebo Laser
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 37 32
Measure Type: Number
Unit of Measure: participants
23 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erchonia HPS Laser, Placebo Laser
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.00005
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Change in Heel Pain Score on the Visual Analog Scale (VAS)
Hide Description 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.
Time Frame baseline and 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erchonia HPS Laser Placebo Laser
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 37 32
Mean (Standard Deviation)
Unit of Measure: scores on a 0-100 VAS scale
-29.47  (24.94) -5.38  (16.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erchonia HPS Laser, Placebo Laser
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments t-test for two independent samples to compare the change in VAS scores across the evaluation period between the two procedure administration groups
Time Frame 5 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Erchonia HPS Laser Placebo Laser
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Erchonia HPS Laser Placebo Laser
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Erchonia HPS Laser Placebo Laser
Affected / at Risk (%) Affected / at Risk (%)
Total   0/37 (0.00%)   0/32 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Erchonia HPS Laser Placebo Laser
Affected / at Risk (%) Affected / at Risk (%)
Total   0/37 (0.00%)   0/32 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Coughlin, MD
Organization: Coughlin Foot and Ankle Clinic
Phone: 208-367-3330
EMail: thefootmd@gmail.com
Layout table for additonal information
Responsible Party: Erchonia Corporation
ClinicalTrials.gov Identifier: NCT01835743     History of Changes
Other Study ID Numbers: EC_HP_001
First Submitted: April 17, 2013
First Posted: April 19, 2013
Results First Submitted: April 4, 2014
Results First Posted: June 3, 2014
Last Update Posted: June 3, 2014