Low Level Laser Light Therapy and Chronic Neck and Shoulder Pain

A study testing Erchonia PL2000 in people with Shoulder Pain and Neck Pain, run by Erchonia Corporation.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Shoulder Pain, Neck Pain, Musculoskeletal Pain
What is being tested?: Erchonia PL2000
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: No sites listed yet
Study dates: Jan 2001to Jun 2001
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

About this study

Official 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.

Read the detailed description

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.

Conditions: Shoulder Pain, Neck Pain, Musculoskeletal Pain, Musculoskeletal Strain, Musculoskeletal Sprain
Being tested: Erchonia PL2000, Placebo laser
Keywords: chronic pain, neck, shoulder, musculoskeletal origin
Medical subject headings: Shoulder Pain, Neck Pain, Musculoskeletal Pain, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Erchonia PL2000Device
Also called Erchonia PL5000, Erchonia EVRL Laser
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.
Placebo laserDevice
Inactive laser light

Study groups in NCT00929305
Study group	Role	What they receive
Placebo laser	Placebo comparator	inactive laser light Receives: Device: Placebo laser
Erchonia PL2000	Active comparator	The Erchonia PL2000 Laser emits 1 milliWatt (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. Receives: Device: Erchonia PL2000

What is being measured

The primary outcome is the main question the study is designed to answer.

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
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.
Measured: baseline and one day
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
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.
Measured: baseline and one day

Secondary outcomes (2)

Range of Motion of the Neck and Shoulders
Measured: one day
Muscle Trigger Points of the Cervical Spine
Measured: one day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2001Jun 2001

First posted29 Jun 2009 (estimated)
Study startJan 2001
Primary completionJun 2001
Study completionJun 2001

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Shoulder PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00929305
Sponsor's protocol ID: ECP-002
Status last verified: Apr 2014
First submitted: 25 Jun 2009
Last updated: 21 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Shoulder Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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.
ClinicalTrials.gov ID: NCT00929305
Acronym / sponsor ID: ECP-002
Conditions: Shoulder Pain, Neck Pain, Musculoskeletal Pain, Musculoskeletal Strain, Musculoskeletal Sprain
Keywords: chronic pain, neck, shoulder, musculoskeletal origin
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Erchonia CorporationIndustry (pharma, biotech, devices)
Study start: Jan 2001
Primary completion: Jun 2001 (actual)
Study completion: Jun 2001 (actual)
First posted: 29 Jun 2009 (estimated)
Results: Posted 22 Apr 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo laser	Placebo comparator	Device: Placebo laserinactive laser light
Erchonia PL2000	Active comparator	Device: Erchonia PL2000The Erchonia PL2000 Laser emits 1 milliWatt (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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Erchonia PL2000Also: Erchonia PL5000, Erchonia EVRL LaserThe 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.	Device	Erchonia PL2000
Placebo laserInactive laser light	Device	Placebo laser

Primary outcome

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.
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.

2 secondary outcomes

Range of Motion of the Neck and Shoulders
Time frame: one day
Muscle Trigger Points of the Cervical Spine
Time frame: one day

Results and safety

Results posted to the registry on 22 Apr 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Laser	43	43
Erchonia PL2000	43	43

Primary outcome: 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. Number. Unit: participants

Measure	Placebo Laser n = 43	Erchonia PL2000 n = 43
Value	5	28

Placebo Laser vs Erchonia PL2000: p <0.0001, Fisher Exact

Primary outcome: 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. Mean (Standard Deviation). Unit: units on a scale

Measure	Placebo Laser n = 43	Erchonia PL2000 n = 43
Value	-4.34 (14.01)	-28.06 (19.95)

Placebo Laser vs Erchonia PL2000: p <0.0001, t-test, 2 sided

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Laser	0 of 43 (0%)	0 of 43 (0%)	Not reported
Erchonia PL2000	0 of 43 (0%)	0 of 43 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
FDA 510(k)#K012580 clearance based on the results of this studyLink provided by the sponsor.
FDA 510(k)#K050672 clearance based on this study's resultsLink provided by the sponsor.

Related trials for Shoulder Pain

Not yet recruitingPhase 4
Methylprednisolone Taper is an Effective Addition to Multimodal Pain Regimens After Rotator Cuff Repair
Shoulder
Not yet recruiting
ESP Versus SPSIP Block for Pain Relief After Shoulder Arthroscopy
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Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
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Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
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Active, not recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gregory C Roche, DO principal investigator

Douglas D Dedo, MD principal investigator

Edward B Lack, MD principal investigator

Questions about this trial

What is this clinical trial studying?

A study testing Erchonia PL2000 in people with Shoulder Pain and Neck Pain, run by Erchonia Corporation.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00929305.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2014.