Trial Outcomes & Findings for Low Level Laser Light Therapy and Chronic Neck and Shoulder Pain (NCT NCT00929305)

Last Updated: 2014-04-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

100 participants

Primary outcome timeframe

baseline and one day

Results posted on

2014-04-21

Participant Flow

Recruitment period was June-July, 2001. Locations were 3 private practice test sites: 2 in California and one in Virginia.

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.

Participant milestones

Participant milestones
Measure	Placebo Laser inactive laser light	Erchonia PL2000 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 Study STARTED	43	43
Overall Study COMPLETED	43	43
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Low Level Laser Light Therapy and Chronic Neck and Shoulder Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Laser n=43 Participants inactive laser light	Erchonia PL2000 n=43 Participants 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 n=86 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	43 Participants n=5 Participants	43 Participants n=7 Participants	86 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	26 Participants n=7 Participants	49 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	17 Participants n=7 Participants	37 Participants n=5 Participants
Location of Pain Neck only	16 participants n=5 Participants	13 participants n=7 Participants	29 participants n=5 Participants
Location of Pain Shoulder only	4 participants n=5 Participants	7 participants n=7 Participants	11 participants n=5 Participants
Location of Pain Both Neck & Shoulder	23 participants n=5 Participants	23 participants n=7 Participants	46 participants n=5 Participants
Origin of Pain muscle spasms and sprain strain	26 participants n=5 Participants	31 participants n=7 Participants	57 participants n=5 Participants
Origin of Pain muscle spasms only	10 participants n=5 Participants	5 participants n=7 Participants	15 participants n=5 Participants
Origin of Pain osteoarthritis	7 participants n=5 Participants	7 participants n=7 Participants	14 participants n=5 Participants
Baseline Visual Analog Scale (VAS) pain rating	60.00 units on a scale STANDARD_DEVIATION 8.60 • n=5 Participants	60.21 units on a scale STANDARD_DEVIATION 9.84 • n=7 Participants	60.10 units on a scale STANDARD_DEVIATION 9.19 • n=5 Participants
Duration of Pain	82.95 months STANDARD_DEVIATION 86.14 • n=5 Participants	61.74 months STANDARD_DEVIATION 77.21 • n=7 Participants	72.35 months STANDARD_DEVIATION 82.01 • n=5 Participants

PRIMARY outcome

Timeframe: baseline and one day

Outcome measures

Outcome measures
Measure	Placebo Laser n=43 Participants inactive laser light	Erchonia PL2000 n=43 Participants 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.
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	5 participants	28 participants

PRIMARY outcome

Timeframe: baseline and one day

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.

Outcome measures

Outcome measures
Measure	Placebo Laser n=43 Participants inactive laser light	Erchonia PL2000 n=43 Participants 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.
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	-4.34 units on a scale Standard Deviation 14.01	-28.06 units on a scale Standard Deviation 19.95

SECONDARY outcome

Timeframe: one day

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one day

Outcome measures

Outcome data not reported

Adverse Events

Placebo Laser

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Erchonia PL2000

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

Elvira Walls, Clinical Consultant

Regulatory Insight, Inc.

Phone: 615-712-9743

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place