Musculoskeletal PainNCT07121933
Evaluation of Erchonia PPL Laser as a Pretreatment Adjunct to Enhance Standard Erchonia Red Laser for the Relief of Pain
A study testing Erchonia® PPL blue laser therapy, followed sequentially with the standard Erchonia red laser therapy in people with Musculoskeletal Pain, run by Erchonia Corporation at 1 site in United States.
Trial summary
This study is to see if applying pre-treatment with the Erchonia® PPL blue laser therapy, followed sequentially with the standard Erchonia red laser therapy can help reduce nociceptive musculoskeletal pain Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- Erchonia® PPL blue laser therapy, followed sequentially with the standard Erchonia red laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2025to 28 Mar 2026
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 22 years of age or older
- Primary language is English
- Subject presents with with one or more of:
- chronic neck pain on the right side of the neck and/or the left side of the neck and/or the back of the neck; and/or
- chronic shoulder pain on the right shoulder and/or the left shoulder.
- Subject is diagnosed with of one or more of the following:
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- Osteoarthritis: Degenerative Joint Disorder (DJD)
- Chronic Muscle Spasms
- Cervical and Thoracic Spine Sprain Strain
- Pain is chronic, having persisted for longer than the past 30 days
- Self-reported Pain rating on the 0-100 Visual Analog Scale (VAS) of 50 or greater.
- Willing and able to refrain from consuming any over-the-counter and/or prescription medication(s) and/or herbal supplements intended for the relief of pain and/or inflammation, including muscle relaxants throughout the course of study participation.
- Willing and able to refrain from engaging in any non-study procedure therapies throughout the course of study participation, including conventional therapies such as physical therapy, occupational therapy and hot or cold packs, as well as alternative therapies such as chiropractic care and acupuncture
Who cannot join
- Presenting primary pain is located outside or in addition to the region of the neck (right side/left side/back) or the shoulder (right and/or left side)
- Etiology of neck/shoulder pain cannot be definitively diagnosed; or has bene diagnosed as being in whole or in part other than that of osteoarthritis, chronic muscle spasms or cervical and thoracic spine sprain strain; or other potentially contributing etiologies cannot be satisfactorily ruled out
- Pain is acute: symptoms prevailed for fewer than each of the prior 30 days
- Current active chronic pain disease: such as chronic fatigue syndrome and fibromyalgia
- Use of analgesics or muscle relaxants within 7 days prior to study procedure administration
- Use of systemic corticosteroid therapy (inhaled and topical corticosteroids permitted), narcotics or Botulinum toxin (Botox®) injection in the neck / shoulder region within 30 days prior to study procedure administration
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- Active cancer or treatment for cancer within the last 6 months
- Unstable cardiac disease, such as recent cardiac arrhythmia, congestive heart failure or myocardial infarction
- Prior surgery to the neck/shoulder region
- Known herniated disc injury
- Active infection, would or other external trauma to the areas to be treated with the laser
- Medical, physical, or other contraindications for or sensitivity to light therapy
- Serious known mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years
- Pregnant or breast feeding
- Participation in a research study within the past 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluation of The Erchonia® PPL Laser as a Pre-Treatment Adjunct to Enhance Standard Erchonia Red Laser Therapy for the Temporary Relief of Nociceptive Musculoskeletal Pain
This study is to see if applying pre-treatment with the Erchonia® PPL blue laser therapy, followed sequentially with the standard Erchonia red laser therapy can help reduce nociceptive musculoskeletal pain
Read the detailed description
It is the goal of this single (active) group study to evaluate the efficacy of the pre-treatment with the Erchonia® PPL blue laser therapy, followed sequentially with the standard Erchonia red laser therapy, is non-inferior to (equivalent to or superior to) the standard Erchonia red laser therapy when applied alone in providing temporary relief of nociceptive musculoskeletal pain
- Conditions
- Musculoskeletal Pain
- Being tested
- Erchonia® PPL blue laser therapy, followed sequentially with the standard Erchonia red laser therapy
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erchonia® PPL blue laser therapy, followed sequentially with the standard Erchonia red laser therapyDevice
450 nanometers (nm) blue dual-diode laser application followed by 640nm red laser application
| Study group | Role | What they receive |
|---|---|---|
| Erchonia® PPL | Experimental | Not described Receives: Device: Erchonia® PPL blue laser therapy, followed sequentially with the standard Erchonia red laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) from one day, baseline to endpoint measurement (following 13-minute treatment administration) is calculated for each subject. Individual subject success is defined as a 30% or greater change in VAS pain scores across the evaluation period. A negative (-) percent change indicates a decrease in pain level and is positive for individual subject success. A positive (+) percent change indicates an increase in pain level and is negative for individual subject success.
Overall study success criteria is defined as at least 65%±5% (percentage of subjects) meeting the study individual success criteria.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start20 Aug 2025
- Primary completion26 Mar 2026
- Study completion28 Mar 2026
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 Musculoskeletal 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erchonia Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121933
- Sponsor's protocol ID
- R-PPL
- Status last verified
- May 2026
- First submitted
- 12 Aug 2025
- Last updated
- 4 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of The Erchonia® PPL Laser as a Pre-Treatment Adjunct to Enhance Standard Erchonia Red Laser Therapy for the Temporary Relief of Nociceptive Musculoskeletal Pain
- ClinicalTrials.gov ID
- NCT07121933
- Acronym / sponsor ID
- R-PPL
- Conditions
- Musculoskeletal Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Erchonia CorporationIndustry (pharma, biotech, devices)
- Study start
- 20 Aug 2025 (actual)
- Primary completion
- 26 Mar 2026 (actual)
- Study completion
- 28 Mar 2026 (actual)
- First posted
- 14 Aug 2025 (actual)
- Results
- Posted 4 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to see if applying pre-treatment with the Erchonia® PPL blue laser therapy, followed sequentially with the standard Erchonia red laser therapy can help reduce nociceptive musculoskeletal pain
Detailed description
It is the goal of this single (active) group study to evaluate the efficacy of the pre-treatment with the Erchonia® PPL blue laser therapy, followed sequentially with the standard Erchonia red laser therapy, is non-inferior to (equivalent to or superior to) the standard Erchonia red laser therapy when applied alone in providing temporary relief of nociceptive musculoskeletal pain
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erchonia® PPL | Experimental | Device: Erchonia® PPL blue laser therapy, followed sequentially with the standard Erchonia red laser therapy |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 22 years of age or older
- Primary language is English
- Subject presents with with one or more of:
- Subject is diagnosed with of one or more of the following:
- Pain is chronic, having persisted for longer than the past 30 days
Key exclusion criteria (15 listed)
- Presenting primary pain is located outside or in addition to the region of the neck (right side/left side/back) or the shoulder (right and/or left side)
- Etiology of neck/shoulder pain cannot be definitively diagnosed; or has bene diagnosed as being in whole or in part other than that of osteoarthritis, chronic muscle spasms or cervical and thoracic spine sprain strain; or other potentially contributing etiologies cannot be satisfactorily ruled out
- Pain is acute: symptoms prevailed for fewer than each of the prior 30 days
- Current active chronic pain disease: such as chronic fatigue syndrome and fibromyalgia
- Use of analgesics or muscle relaxants within 7 days prior to study procedure administration
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® PPL blue laser therapy, followed sequentially with the standard Erchonia red laser therapy450 nanometers (nm) blue dual-diode laser application followed by 640nm red laser application | Device | Erchonia® PPL |
Primary outcome
Percentage of Subjects With 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS)
Time frame: Day 1
The Visual Analog Scale (VAS) from one day, baseline to endpoint measurement (following 13-minute treatment administration) is calculated for each subject. Individual subject success is defined as a 30% or greater change in VAS pain scores across the evaluation period. A negative (-) percent change indicates a decrease in pain level and is positive for individual subject success. A positive (+) percent change indicates an increase in pain level and is negative for individual subject success. Overall study success criteria is defined as at least 65%±5% (percentage of subjects) meeting the study individual success criteria.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erchonia® PPL blue laser therapy, followed sequentially with the standard Erchonia red laser therapy in people with Musculoskeletal Pain, run by Erchonia Corporation at 1 site in United States.
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 13 inclusion and 15 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 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 4 Jun 2026). 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?
Percentage of Subjects With 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS) (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.