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Completed

NCT Number: NCT00929773

Low Level Laser Therapy to Reduce Chronic Pain

The purpose of this study was to determine whether low level laser light directed at the neck and shoulders could be effective in the temporary reduction of chronic pain in the neck and shoulder region.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Chronic neck and shoulder pain arising from osteoarthritis, chronic muscle spasms or thoracic or cervical spine sprain strain can be seriously debilitating. Currently available treatment options such as pain relief medication, ice pack, massage, physical therapy and chiropractic are typically of limited effectiveness. More permanent options such as surgery are invasive with long recovery periods and side-effects and complications of their own. Low level laser light therapy, with its proven anti-inflammatory ability, offers a simple non-invasive option for the reduction of chronic neck and shoulder pain.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Muscular-skeletal pain in the neck/shoulder region
  • Acute and chronic pain in the neck/shoulder region
  • Restricted range of motion in the neck/shoulder region
  • Fibrosis or scar tissue in the neck/shoulder region
  • Inflammation in the neck/shoulder region
  • Altered function in the neck/shoulder region
  • Muscle strains in the neck/shoulder region
  • Rating of 30 or greater on the 0-100 Visual Analog Scale (VAS) pain scale
  • 18-65 years of age

Exclusion criteria

  • Severely herniated disks
  • Pregnancy
  • Taken pain medication within the past 12 hours

Treatment and study plan

Erchonia PL2000 Laser

Device

Low level laser light therapy device that emits 1 mW of red (635 nm wavelength) light. It is a hand-held device that uses rechargeable batteries or a separate power adapter.

Other names: Erchonia PL5000, Erchonia EVRL Laser

Placebo Laser

Device

Inactive laser light.

Primary outcomes

  1. 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.

    Time frame: 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.

  2. Change in Self-reported Degree of Pain in the Neck-shoulder Region on the 0-100 Visual Analog Scale (VAS)

    Time frame: 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.

Secondary outcomes

  1. Change in Range of Motion (ROM) for the Left Side of the Neck From Baseline to One Hour After Study Treatment.

    Time frame: 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

  2. Change in Range of Motion (ROM) for the Left Shoulder From Baseline to One Hour After Study Treatment.

    Time frame: 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

  3. Change in Range of Motion (ROM) for the Right Side of the Neck From Baseline to One Hour After Study Treatment.

    Time frame: 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.

  4. Change in Range of Motion (ROM) for the Right Shoulder From Baseline to One Hour After Study Treatment.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Erchonia Corporation

Industry

Registry information

Official study title

Study of the Effect of Low Level Laser Light Therapy on the Reduction of Chronic Pain of the Neck and Shoulders

Important dates

Study start
2000
Primary completion
2000
Study completion
2000
First posted
Jun 29, 2009
Registry last updated
May 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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