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Completed

NCT Number: NCT00929305

Low Level Laser Light Therapy and Chronic Neck and Shoulder Pain

The purpose of this study was to determine whether the application of low level laser light therapy to the neck and shoulder region is effective in reducing chronic neck and shoulder pain of musculoskeletal origin.

Completed

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Key information

Conditions

Shoulder Pain Arthralgia Chronic Pain Joint Diseases Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Musculoskeletal Sprain Musculoskeletal Strain Neck 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

  • Location of pain is on the right and/or left side of the neck and/or shoulder and/or the back of the neck.
  • Etiology of pain is osteoarthritis/Degenerative Joint Disorder (DJD); chronic muscle spasms or cervical and thoracic spine sprain strain, determined according to subject medical history, medication use history, previous records review, physical examination of the cervical spine and shoulder.
  • Stage of injury is chronic, having prevailed for longer than 30 days.
  • Degree of Pain self-rating of 50 or greater on the 0-100 Visual Analog Scale (VAS).
  • 18-65 years.

Exclusion criteria

  • Stage of injury is acute, having prevailed for less than 30 days.
  • Known herniated disc injury.
  • Any other disease or condition that may cause or contribute to the chronic pain condition.
  • Presence of infection or open wound at the treatment areas.
  • Use of steroids or narcotics.
  • Use of over-the-counter (OTC) medication for the relief of pain within the 24-hour period prior to participating in the treatment phase of the study, or prescription medication for the relief of pain within the 48-hour period prior to participating in the treatment phase of the study.
  • pregnant or lactating.

Treatment and study plan

Erchonia PL2000

Device

The Erchonia PL2000 Laser emits 1 mW of red (635nm wavelength) light via an electric diode energy source. 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. 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

    Time frame: 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 each point in time. The higher the number marked, the greater the pain level.

  2. 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

    Time frame: 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.

Secondary outcomes

  1. Range of Motion of the Neck and Shoulders

    Time frame: one day

  2. Muscle Trigger Points of the Cervical Spine

    Time frame: one day

Sponsors and collaborators

Lead sponsor

Erchonia Corporation

Industry

Registry information

Official study title

Study of the Effect of Low Level Laser Therapy on the Reduction of Chronic Pain Associated With Neck and Shoulder Pain of Musculoskeletal Origin.

Important dates

Study start
2001
Primary completion
2001
Study completion
2001
First posted
Jun 29, 2009
Registry last updated
Apr 21, 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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