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Low Level Laser Therapy to Reduce Chronic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00929773
Recruitment Status : Completed
First Posted : June 29, 2009
Results First Posted : May 2, 2014
Last Update Posted : May 2, 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 Chronic Pain
Interventions Device: Erchonia PL2000 Laser
Device: Placebo laser
Enrollment 100
Recruitment Details Recruitment period was July through September, 2000 at a single medical clinic.
Pre-assignment Details Following enrollment and prior to group assignment, study participants underwent study qualification evaluation which included a self-report rating of current neck and/or shoulder pain level on the 0-100 VAS.
Arm/Group Title Erchonia PL2000 Laser Placebo Laser
Hide Arm/Group Description Low level laser energy comprised of 1 milliWatt (mW) of near-infrared light (635 nm) to the neck and shoulder area . inactive light
Period Title: Overall Study
Started 50 50
Completed 50 50
Not Completed 0 0
Arm/Group Title Erchonia Low Level Laser Therapy Placebo Laser Total
Hide Arm/Group Description Low level laser energy comprised of 1 mw of near-infrared light (635 nm) to the neck and shoulder area . inactive light Total of all reporting groups
Overall Number of Baseline Participants 50 50 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
50
 100.0%
50
 100.0%
100
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Female
25
  50.0%
25
  50.0%
50
  50.0%
Male
25
  50.0%
25
  50.0%
50
  50.0%
Location of Pain   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Shoulders 10 14 24
Neck 13 14 27
Neck & Shoulders 27 22 49
[1]
Measure Description: Subject report of pain located in the neck, shoulder or both regions.
Type of Pain  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Chronic 43 44 87
Acute 7 6 13
Pain Rating on the Visual Analog Scale (VAS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 50 participants 50 participants 100 participants
51.14  (16.50) 49.06  (19.48) 50.10  (18.00)
[1]
Measure Description: The Visual Analog Scale (VAS) is used as a self-reported measure of current pain level. Participants mark the spot on the line scale that shows the level of their pain at that time. The scale ranges fron '0: no pain at all' to '100: worst pain imaginable.' The scale is a straight line of 100mm. The point marked by the participant is measured as their current pain level. The higher the number, the greater the pain level. To qualify to be in the study, participants needed to record a Baseline pain level on the VAS of 30 or greater.
Duration of Pain  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 50 participants 50 participants 100 participants
57.11  (121.40) 40.25  (71.13) 48.15  (97.64)
1.Primary Outcome
Title Number of Participants Whose Self-reported Degree of Pain on the Visual Analog Scale (VAS) in the Neck and Shoulder Area Decreased by 30% or More From Before to After Study Treatment.
Hide Description Self-reported degree of pain in the neck and shoulder region on the Visual Analog Scale (VAS). The VAS is a 100 mm long horizontal line ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end. Participants mark a point along the line that best represents the pain they are experiencing at that moment.
Time Frame baseline and one hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erchonia PL2000 Laser Placebo Laser
Hide Arm/Group Description:
Low level laser energy comprised of 1 mW of near-infrared light (635 nm) to the neck and shoulder area .
inactive light
Overall Number of Participants Analyzed 50 50
Measure Type: Number
Unit of Measure: participants
40 7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erchonia PL2000 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 Fisher Exact
Comments [Not Specified]
2.Primary Outcome
Title Change in Self-reported Degree of Pain in the Neck-shoulder Region on the 0-100 Visual Analog Scale (VAS)
Hide Description Self-reported degree of pain in the neck and shoulder region on the Visual Analog Scale (VAS). The VAS is a 100 mm long horizontal line ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end. Participants mark a point along the line that best represents the pain they are experiencing at that moment. The change is calculated as the difference from the VAS score recorded at baseline to the VAS score recorded one hour after study treatment administration. A positive change (+) means that the pain got worse and a negative change (-) means that the pain got better.
Time Frame baseline and one hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erchonia PL2000 Laser Placebo Laser
Hide Arm/Group Description:
Low level laser energy comprised of 1 mW of near-infrared light (635 nm) to the neck and shoulder area .
inactive light
Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
-27.38  (19.28) -2.43  (12.57)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erchonia PL2000 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 [Not Specified]
3.Secondary Outcome
Title Change in Range of Motion (ROM) for the Left Side of the Neck From Baseline to One Hour After Study Treatment.
Hide Description Range of motion (ROM) for the left side of the neck is a measure of how well the neck can move to the left side. The participant gently tilts their neck to the left side as far as possible, and this distance is measured in degrees. The change for ROM for the left side of the neck is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment. If the change is positive (+), this means that ROM has gotten better and the neck can move further to the left side than before getting the treatment. If the change is negative (-), this means that ROM has gotten worse and the neck can move less to the left side than before getting the treatment
Time Frame baseline and one hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erchonia PL2000 Laser Placebo Laser
Hide Arm/Group Description:
Low level laser energy comprised of 1 mW of near-infrared light (635 nm) to the neck and shoulder area.
inactive light
Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: degrees
11.28  (9.64) 0.02  (6.90)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erchonia PL2000 Laser, Placebo Laser
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Change in Range of Motion (ROM) for the Left Shoulder From Baseline to One Hour After Study Treatment.
Hide Description Range of motion (ROM) for the left shoulder is a measure of how well the participant can move the left shoulder. The participant gently raises the left shoulder (and left arm) as far as possible, and this distance is measured in degrees. The change for ROM for the left shoulder is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment. If the change is positive (+), this means that ROM has gotten better and can move the left shoulder better and further than before getting the treatment. If the change is negative (-), this means that ROM has gotten worse and the left shoulder can move less easily and not as far than before getting the treatment
Time Frame one hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erchonia PL2000 Laser Placebo Laser
Hide Arm/Group Description:
Low level laser energy comprised of 1 mW of near-infrared light (635 nm) to the neck and shoulder area .
inactive light
Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: degrees
28.00  (22.67) 2.24  (0.33)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erchonia PL2000 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 [Not Specified]
5.Secondary Outcome
Title Change in Range of Motion (ROM) for the Right Side of the Neck From Baseline to One Hour After Study Treatment.
Hide Description Range of motion (ROM) for the right side of the neck is a measure of how well the neck can move to the right side. The participant gently tilts their neck to the right side as far as possible, and this distance is measured in degrees. The change for ROM for the right side of the neck is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment. If the change is positive (+), this means that ROM has gotten better and the neck can move further to the right side than before getting the treatment. If the change is negative (-), this means that ROM has gotten worse and the neck can move less to the right side than before getting the treatment.
Time Frame baseline and one hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erchonia PL2000 Laser Placebo Laser
Hide Arm/Group Description:
Low level laser energy comprised of 1 mW of near-infrared light (635 nm) to the neck and shoulder area .
inactive light
Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: degrees
11.06  (9.63) 0.72  (7.58)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erchonia PL2000 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 [Not Specified]
6.Secondary Outcome
Title Change in Range of Motion (ROM) for the Right Shoulder From Baseline to One Hour After Study Treatment.
Hide Description Range of motion (ROM) for the right shoulder is a measure of how well the participant can move the right shoulder. The participant gently raises the right shoulder (with right arm) as far as possible, and this distance is measured in degrees. The change for ROM for the right shoulder is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment. If the change is positive (+), this means that ROM has gotten better and the right shoulder can move further more easily than before getting the treatment. If the change is negative (-), this means that ROM has gotten worse and the right shoulder can move less and not as far to the left side than before getting the treatment.
Time Frame baseline and one hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erchonia PL2000 Laser Placebo Laser
Hide Arm/Group Description:
Low level laser energy comprised of 1 mW of near-infrared light (635 nm) to the neck and shoulder area.
inactive light
Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: degrees
30.90  (25.97) 1.70  (11.60)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erchonia PL2000 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 [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Erchonia Low Level Laser Therapy Placebo Laser
Hide Arm/Group Description Low level laser energy comprised of 1 mw of near-infrared light (635 nm) to the neck and shoulder area . inactive light
All-Cause Mortality
Erchonia Low Level Laser Therapy Placebo Laser
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Erchonia Low Level Laser Therapy Placebo Laser
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Erchonia Low Level Laser Therapy Placebo Laser
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (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: Elvira Walls, Clinical Consultant
Organization: Regulatory Insight, Inc.
Phone: 615-712-9743
EMail: elvira@reginsight.com
Layout table for additonal information
Responsible Party: Erchonia Corporation
ClinicalTrials.gov Identifier: NCT00929773    
Other Study ID Numbers: ECP-001
First Submitted: June 25, 2009
First Posted: June 29, 2009
Results First Submitted: July 6, 2009
Results First Posted: May 2, 2014
Last Update Posted: May 2, 2014