Trial Outcomes & Findings for Low Level Laser Therapy to Reduce Chronic Pain (NCT NCT00929773)

NCT ID: NCT00929773

Last Updated: 2014-05-02

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

100 participants

Primary outcome timeframe

baseline and one hour

Results posted on

2014-05-02

Participant Flow

Recruitment period was July through September, 2000 at a single medical clinic.

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.

Participant milestones

Participant milestones
Measure	Erchonia PL2000 Laser Low level laser energy comprised of 1 milliWatt (mW) of near-infrared light (635 nm) to the neck and shoulder area .	Placebo Laser inactive light
Overall Study STARTED	50	50
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Low Level Laser Therapy to Reduce Chronic Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Erchonia Low Level Laser Therapy n=50 Participants Low level laser energy comprised of 1 mw of near-infrared light (635 nm) to the neck and shoulder area .	Placebo Laser n=50 Participants inactive light	Total n=100 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	50 Participants n=5 Participants	50 Participants n=7 Participants	100 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	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Location of Pain Shoulders	10 participants n=5 Participants	14 participants n=7 Participants	24 participants n=5 Participants
Location of Pain Neck	13 participants n=5 Participants	14 participants n=7 Participants	27 participants n=5 Participants
Location of Pain Neck & Shoulders	27 participants n=5 Participants	22 participants n=7 Participants	49 participants n=5 Participants
Type of Pain Chronic	43 participants n=5 Participants	44 participants n=7 Participants	87 participants n=5 Participants
Type of Pain Acute	7 participants n=5 Participants	6 participants n=7 Participants	13 participants n=5 Participants
Pain Rating on the Visual Analog Scale (VAS)	51.14 units on a scale STANDARD_DEVIATION 16.50 • n=5 Participants	49.06 units on a scale STANDARD_DEVIATION 19.48 • n=7 Participants	50.10 units on a scale STANDARD_DEVIATION 18.00 • n=5 Participants
Duration of Pain	57.11 months STANDARD_DEVIATION 121.40 • n=5 Participants	40.25 months STANDARD_DEVIATION 71.13 • n=7 Participants	48.15 months STANDARD_DEVIATION 97.64 • n=5 Participants

PRIMARY outcome

Timeframe: baseline and one hour

Outcome measures

Outcome measures
Measure	Erchonia PL2000 Laser n=50 Participants Low level laser energy comprised of 1 mW of near-infrared light (635 nm) to the neck and shoulder area .	Placebo Laser n=50 Participants inactive light
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.	40 participants	7 participants

PRIMARY outcome

Timeframe: baseline and one hour

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.

Outcome measures

Outcome measures
Measure	Erchonia PL2000 Laser n=50 Participants Low level laser energy comprised of 1 mW of near-infrared light (635 nm) to the neck and shoulder area .	Placebo Laser n=50 Participants inactive light
Change in Self-reported Degree of Pain in the Neck-shoulder Region on the 0-100 Visual Analog Scale (VAS)	-27.38 units on a scale Standard Deviation 19.28	-2.43 units on a scale Standard Deviation 12.57

SECONDARY outcome

Timeframe: baseline and one hour

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

Outcome measures

Outcome measures
Measure	Erchonia PL2000 Laser n=50 Participants Low level laser energy comprised of 1 mW of near-infrared light (635 nm) to the neck and shoulder area .	Placebo Laser n=50 Participants inactive light
Change in Range of Motion (ROM) for the Left Side of the Neck From Baseline to One Hour After Study Treatment.	11.28 degrees Standard Deviation 9.64	0.02 degrees Standard Deviation 6.90

SECONDARY outcome

Timeframe: one hour

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

Outcome measures

Outcome measures
Measure	Erchonia PL2000 Laser n=50 Participants Low level laser energy comprised of 1 mW of near-infrared light (635 nm) to the neck and shoulder area .	Placebo Laser n=50 Participants inactive light
Change in Range of Motion (ROM) for the Left Shoulder From Baseline to One Hour After Study Treatment.	28.00 degrees Standard Deviation 22.67	2.24 degrees Standard Deviation 0.33

SECONDARY outcome

Timeframe: baseline and one hour

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.

Outcome measures

Outcome measures
Measure	Erchonia PL2000 Laser n=50 Participants Low level laser energy comprised of 1 mW of near-infrared light (635 nm) to the neck and shoulder area .	Placebo Laser n=50 Participants inactive light
Change in Range of Motion (ROM) for the Right Side of the Neck From Baseline to One Hour After Study Treatment.	11.06 degrees Standard Deviation 9.63	0.72 degrees Standard Deviation 7.58

SECONDARY outcome

Timeframe: baseline and one hour

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.

Outcome measures

Outcome measures
Measure	Erchonia PL2000 Laser n=50 Participants Low level laser energy comprised of 1 mW of near-infrared light (635 nm) to the neck and shoulder area .	Placebo Laser n=50 Participants inactive light
Change in Range of Motion (ROM) for the Right Shoulder From Baseline to One Hour After Study Treatment.	30.90 degrees Standard Deviation 25.97	1.70 degrees Standard Deviation 11.60

Adverse Events

Erchonia Low Level Laser Therapy

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

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