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Low Level Laser Light Therapy and Chronic Neck and Shoulder 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: NCT00929305
Recruitment Status : Completed
First Posted : June 29, 2009
Results First Posted : April 22, 2013
Last Update Posted : April 21, 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
Conditions Shoulder Pain
Neck Pain
Musculoskeletal Pain
Musculoskeletal Strain
Musculoskeletal Sprain
Interventions Device: Erchonia PL2000
Device: Placebo laser
Enrollment 100
Recruitment Details Recruitment period was June-July, 2001. Locations were 3 private practice test sites: 2 in California and one in Virginia.
Pre-assignment Details 14 enrolled participants were subsequently excluded for taking study excluded medications, for having a self-reported pre-treatment pain Visual Analog Score (VAS) of less than 50 and for having a herniated disc injury.
Arm/Group Title Placebo Laser Erchonia PL2000
Hide Arm/Group Description inactive laser light The Erchonia EVRL Laser emits 1 mw of red (635nm wavelength) light via an electric diode energy source (CDRH Class II). It is a hand-held device that uses rechargeable batteries or a separate AC power adapter.
Period Title: Overall Study
Started 43 43
Completed 43 43
Not Completed 0 0
Arm/Group Title Placebo Laser Erchonia PL2000 Total
Hide Arm/Group Description inactive laser light The Erchonia EVRL Laser emits 1 mw of red (635nm wavelength) light via an electric diode energy source (CDRH Class II). It is a hand-held device that uses rechargeable batteries or a separate AC power adapter. Total of all reporting groups
Overall Number of Baseline Participants 43 43 86
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 43 participants 86 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
43
 100.0%
43
 100.0%
86
 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 43 participants 43 participants 86 participants
Female
23
  53.5%
26
  60.5%
49
  57.0%
Male
20
  46.5%
17
  39.5%
37
  43.0%
Location of Pain   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 43 participants 43 participants 86 participants
Neck only 16 13 29
Shoulder only 4 7 11
Both Neck & Shoulder 23 23 46
[1]
Measure Description: Pain on the right and/or left sides of the neck and/or shoulders, or both.
Origin of Pain   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 43 participants 43 participants 86 participants
muscle spasms and sprain strain 26 31 57
muscle spasms only 10 5 15
osteoarthritis 7 7 14
[1]
Measure Description: Pain originating from one or more of three etiologies: osteoarthritis; muscle spasms, sprain strain.
Baseline Visual Analog Scale (VAS) pain rating   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 43 participants 43 participants 86 participants
60.00  (8.60) 60.21  (9.84) 60.10  (9.19)
[1]
Measure Description: Participants recorded a self-rating of their degree of pain in the neck-shoulder area before the study treatment was administered on the 0-100 standardized Visual Analog Scale (VAS). The VAS is a 100mm long horizontal line ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end. The participant marked the point along the scale that best represented the level of pain they experienced at that time in the neck-shoulder area. The higher the number marked, the greater the pain level.
Duration of Pain   [1] 
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 43 participants 43 participants 86 participants
82.95  (86.14) 61.74  (77.21) 72.35  (82.01)
[1]
Measure Description: Duration in months of chronic pain in the neck and/or shoulder region.
1.Primary Outcome
Title The Number of Participants Whose Self-reported Pain Rating in the Neck and Shoulder Area on the 0-100 Visual Analog Scale (VAS) Decreased by 30% or More From Baseline to One Day After Study Treatment
Hide Description Participants self-rated the degree of pain experienced in the neck-shoulder region on the 0-100 standardized Visual Analog Scale (VAS) at baseline and one day post-treatment. The VAS is a 100mm long horizontal scale ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end. The participant marked the point along the scale that best showed the pain level they experienced in the neck-shoulder area at each point in time. The higher the number marked, the greater the pain level.
Time Frame baseline and one day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Laser Erchonia PL2000
Hide Arm/Group Description:
inactive laser light
The Erchonia EVRL Laser emits 1 mw of red (635nm wavelength) light via an electric diode energy source (CDRH Class II). It is a hand-held device that uses rechargeable batteries or a separate AC power adapter.
Overall Number of Participants Analyzed 43 43
Measure Type: Number
Unit of Measure: participants
5 28
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Laser, Erchonia PL2000
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 Pain Rating in the Neck and Shoulder Area on the 0-100 Visual Analog Scale (VAS)From Baseline to One Day Post-treatment
Hide Description Participants self-rated the degree of pain experienced in the neck-shoulder region on the 0-100 standardized Visual Analog Scale (VAS) at baseline and one day post-treatment. The VAS is a 100mm long horizontal scale ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end. The participant marked the point along the scale that best showed the pain level they experienced in the neck-shoulder area at that point in time. The higher the number marked, the greater the pain level.
Time Frame baseline and one day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Laser Erchonia PL2000
Hide Arm/Group Description:
inactive laser light
The Erchonia EVRL Laser emits 1 mW of red (635nm wavelength) light via an electric diode energy source (CDRH Class II). It is a hand-held device that uses rechargeable batteries or a separate AC power adapter.
Overall Number of Participants Analyzed 43 43
Mean (Standard Deviation)
Unit of Measure: units on a scale
-4.34  (14.01) -28.06  (19.95)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Laser, Erchonia PL2000
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 Range of Motion of the Neck and Shoulders
Hide Description [Not Specified]
Time Frame one day
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Muscle Trigger Points of the Cervical Spine
Hide Description [Not Specified]
Time Frame one day
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Laser Erchonia PL2000
Hide Arm/Group Description inactive laser light The Erchonia EVRL Laser emits 1 mw of red (635nm wavelength) light via an electric diode energy source (CDRH Class II). It is a hand-held device that uses rechargeable batteries or a separate AC power adapter.
All-Cause Mortality
Placebo Laser Erchonia PL2000
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Placebo Laser Erchonia PL2000
Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/43 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Laser Erchonia PL2000
Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/43 (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: NCT00929305    
Other Study ID Numbers: ECP-002
First Submitted: June 25, 2009
First Posted: June 29, 2009
Results First Submitted: July 7, 2009
Results First Posted: April 22, 2013
Last Update Posted: April 21, 2014