Nociceptive PainNCT06393088
Clinical Trial of the invisaRED® IR REHAB Device When Used as an Adjunctive Therapy for Nociceptive Musculoskeletal Pain
A study testing IR REHAB in people with Nociceptive Pain and Musculoskeletal Pain, run by IR Technology, LLC at 1 site in United States.
Trial summary
This is a trial to measure the effectiveness and safety of the invisa-RED® IR REHAB device. The researchers will compare the muscle and joint pain relief of participants who are treated with the real machine, to those treated with a non-working "look-a-like" device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nociceptive Pain, Musculoskeletal Pain
- What is being tested?
- IR REHAB
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2024to 30 Aug 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The number of participants is projected to be thirty (30).
- There will be an equitable distribution of male and female participants.
- Women who are pregnant, trying to get pregnant, or nursing will be excluded from the study, as they should not receive Low-level Laser Therapy (LLLT). There is no evidence of harm to a an unborn baby however there have been no safety tests either, so for medical legal reasons we recommend never treating such individuals.
- The participants will be 18 years or older.
- The ethnicity of the participants will be equitably distributed.
- Inclusion criteria will be individuals that may benefit from an adjunctive therapy for musculoskeletal pain.
Who cannot join
- If you are pregnant, trying to get pregnant or nursing laser light therapy should be received only after the end of these conditions. There is no evidence of harm to a an unborn baby however there have been no safety tests either, so for medical legal reasons we recommend never treating areas directly over a developing child.
- Individuals with hypertension, light sensitive epilepsy, cancer, heart disease, infectious skin disease, and severe varicose veins should not use this device.
- People suffering from infectious and acute disease such as a fever should not use this device.
- People who have hemorrhagic disease, vascular ruptures, skin inflammation, or any disease of the skin should not use this device.
- Person with a history of lentigines, an autoimmune vascular disease that causes color changes in the legs or arms due to obstruction or stenosis of blood vessels.
- A person with a history of erythema, an acquired, long-lasting reticulocyte red and pigmented rash, caused by persistent or repeated exposure to intense heat or infrared radiation.
Show all 17Show fewer
- Persons who are susceptible to or have a history of herpes in the treatment area
- Anyone who has experienced problems subsequent to previous laser treatments
- People who have immune system dysfunction such as Leukemia, Hemophilia, etc., and light sensitive persons should not use this device.
- Use of laser light therapy in the ears, nose, eye, or throat is not recommended.
- Individuals with a history of melanoma, raised moles, suspicious lesions, keloid scar formation, or healing problems should not undergo laser light therapy.
- Individuals with active infections, open lesions, hives, herpetic lesions, cold sores, or tattoos and permanent make-up in the area of treatment should not undergo laser light therapy.
- People who have used isotretinoin (commonly known as Accutane), tetracycline, St. John's Wort, or any photo sensitizing drugs in the last year should not undergo laser light therapy.
- Individuals with autoimmune diseases such as Lupus, Scleroderma, or Vitiligo should not undergo laser light therapy.
- Individuals who have pacemakers or other electro-stimulation devices surgically implanted should not undergo laser light therapy.
- Any insulin dependent individual should consult their physician before undergoing laser light therapy.
- All individuals considered "vulnerable" such as children, pregnant women, nursing home residents or other institutionalized persons, students, employees, fetuses, prisoners, and persons with decisional incapacity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial to Establish the Safety and Efficacy of the invisaRED® IR REHAB Device When Used as an Adjunctive Therapy for Nociceptive Musculoskeletal Pain
This is a trial to measure the effectiveness and safety of the invisa-RED® IR REHAB device. The researchers will compare the muscle and joint pain relief of participants who are treated with the real machine, to those treated with a non-working "look-a-like" device. If there is a significant difference of pain relief between those treated with the real machine and those treated with the 'look-a-like' device and no safety issues are discovered, the researchers will be able to assume the IR REHAB device is safe and effective for the treatment of muscle and joint pain.
Read the detailed description
Clinical Trial to Establish the Safety and Efficacy of the IR REHAB Device When Used as an Adjunctive Therapy for Nociceptive Musculoskeletal Pain
Purpose of the Study
The trial is designed to provide data with which to evaluate the efficacy and safety of the invisa-RED® IR REHAB Low-level Laser Therapy (LLLT) device as compared with a sham device when used for the adjunctive treatment of musculoskeletal pain . This will be a single blind trial of two groups of equal number; one group will be treated as usual, the other treated using a sham device. At the conclusion of the trial; results from the two groups will be statistically analyzed to determine the efficacy of the IR REHAB machine for the adjunctive treatment of musculoskeletal pain .
"Musculoskeletal pain is a challenging condition for both patients and physicians. Many adults have experienced one or more episodes of musculoskeletal pain at some time of their lives, regardless of age, gender, or economic status. It affects approximately 47% of the general population. Of those, about 39-45% have long-lasting problems that require medical consultation. Inadequately managed musculoskeletal pain can adversely affect quality of life and impose significant socioeconomic problems."
Monitoring Plan
The study is classified as a minimal risk trial of short duration therefore a detailed plan for monitoring the data for participant safety is not required.
Data Storage and Security
All individuals participating in the trial will be assigned a participant number. Subsequently all clinical records and reports will reference only the participant number, ensuring that participants remain anonymous.
Because of the low number of trial participants, only paper records will be maintained for all clinical and personal data. Records will be kept in locked storage and physical access will only be on a need to know basis. A participants' personal data correlating the participating individuals name and the trial participants Identifying Number will only be available to the principal investigator, clinical staff, and the trial administrator. All analytics will be performed on securely encrypted devices using only data masked or redacted of any personal information.
Risk/Benefit Assessment
Applying the test for the determination of risk established by the FDA Regulation referred to as the "Common Rule" found in 45 Code of Federal Regulations (CFR) 46, Subpart A the rule states;
"Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
The researchers have determined that only a minimal risk is presented to participants of the trial.
All persons interviewed for the trial will be selected using the established invisaRED Technologies IR REHAB guidelines for indications and contraindications. Combining the guidelines for indications and contraindications with the thorough classroom review and "hands on training " for clinicians who will be conducting the trial, the risk is best compared to exposure to sunlight.
Subjects of the study receiving the invisaRED Technologies IR REHAB therapy may receive the following benefits:
- Open up blood vessels to ease swelling
- Help the immune system create more chemicals that heal tissue
- Build more connective tissue in injured area
- Trigger endorphins, natural hormones that ease pain
- Drug free therapy without a chance of addiction
- The therapy is noninvasive
- There are no known side effects
Subject Identification, Recruitment And Consent/Assent
At roadway intersections in close proximity to the research facility signs will be erected containing the verbiage: "Pain and Injury Study, No Cost, Call 770 988-5594" in order to recruit study volunteers from the community.
The clinic's primary care patients will also be provided an opportunity to volunteer for consideration as a trial participant.
The primary investigator will conduct all subject interviews and obtain informed consent. A thorough disclosure of all clinical process, contraindications, and any risk will be discussed with candidates for the trial.
There shall be no cost incurred by candidates for inclusion in the study or individuals selected to participate in the study.
No monetary remuneration will be offered participants in the study. However a commensurate number of treatments with the "as usual" IR REHAB device will be offered for free to those patients who received treatment using the sham device at the conclusion of the clinical trial. This will provide the participants treated with the sham device the opportunity to undergo therapy using an activated IR REHAB device.
Requirements for Human Subject Protection Training
The Primary Investigator and clinical associates conducting the trial will complete the Collaborative Institutional Training Initiative (CITI) course Good Clinical Practice (GCP) for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus).
- Conditions
- Nociceptive Pain, Musculoskeletal Pain
- Being tested
- IR REHAB, Sham
- Keywords
- Low level laser therapy, photobiomodulation, dual frequency, red, near infrared, light
- Medical subject headings
- Nociceptive Pain, Musculoskeletal Pain, Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IR REHABDevice
Participants undergo therapy sessions with active, dual frequency, low level laser therapy device
ShamDevice
Participants undergo therapy sessions with disabled device producing no laser energy
| Study group | Role | What they receive |
|---|---|---|
| IR REHAB Device | Experimental | Participants will receive 6 treatments of 15 minutes each with an active IR REHAB device over the period of three weeks. Receives: Device: IR REHAB |
| Sham Device | Sham comparator | Participants will receive 6 treatments of 15 minutes each with a disabled (sham) IR REHAB device over the period of three weeks. Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measured Change in the Participants Pain Levels
Participants pain levels will be measured using a visual analog scale of 0-100mm where a smaller number indicates a lower perceived pain level and a larger number indicates a higher level of pain. The participant will personally manipulate a visual analog scale with a manual slide indicator to record their pain levels
Measured: Participants pain levels will be recorded over a period of three weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start22 Jul 2024
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nociceptive 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
- Model description
- The trial will compare results between two groups; the first will be treated using the invisa-RED Technology IR REHAB and the second group with a sham device. The trial will be conducted employing a single blind study methodology; participants will not know to which trial group they have been assigned. Participants will undergo six (6) therapy sessions each using a standardized 15 minute protocol. At each of the therapy sessions; the participant will be asked to record their pain level before the treatment session and then in the same manner after the treatment using a Visual Analog Scale (VAS). The results from the two groups will be statistically analyzed to determine the efficacy of the invisa-RED Technology IR REHAB as an adjunctive therapy for musculoskeletal pain. Any medical errors will be included in the statistical analysis.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- IR Technology, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ajibole Abatunde, MD, Principal investigator, Midnight Rose LLC dba Abbycare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393088
- Sponsor's protocol ID
- IR_REHAB_Clinical_Trial
- Status last verified
- Oct 2024
- First submitted
- 26 Apr 2024
- Last updated
- 18 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
El-Tallawy SN, Nalamasu R, Salem GI, LeQuang JAK, Pergolizzi JV, Christo PJ. Management of Musculoskeletal Pain: An Update with Emphasis on Chronic Musculoskeletal Pain. Pain Ther. 2021 Jun;10(1):181-209. doi: 10.1007/s40122-021-00235-2. Epub 2021 Feb 11.
PubMed 33575952
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Establish the Safety and Efficacy of the invisaRED® IR REHAB Device When Used as an Adjunctive Therapy for Nociceptive Musculoskeletal Pain
- ClinicalTrials.gov ID
- NCT06393088
- Acronym / sponsor ID
- IR_REHAB_Clinical_Trial
- Conditions
- Nociceptive Pain, Musculoskeletal Pain
- Keywords
- Low level laser therapy, photobiomodulation, dual frequency, red, near infrared, light
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- IR Technology, LLCIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 1 May 2024 (actual)
- Results
- Posted 18 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a trial to measure the effectiveness and safety of the invisa-RED® IR REHAB device. The researchers will compare the muscle and joint pain relief of participants who are treated with the real machine, to those treated with a non-working "look-a-like" device. If there is a significant difference of pain relief between those treated with the real machine and those treated with the 'look-a-like' device and no safety issues are discovered, the researchers will be able to assume the IR REHAB device is safe and effective for the treatment of muscle and joint pain.
Detailed description
Clinical Trial to Establish the Safety and Efficacy of the IR REHAB Device When Used as an Adjunctive Therapy for Nociceptive Musculoskeletal Pain
Purpose of the Study
The trial is designed to provide data with which to evaluate the efficacy and safety of the invisa-RED® IR REHAB Low-level Laser Therapy (LLLT) device as compared with a sham device when used for the adjunctive treatment of musculoskeletal pain . This will be a single blind trial of two groups of equal number; one group will be treated as usual, the other treated using a sham device. At the conclusion of the trial; results from the two groups will be statistically analyzed to determine the efficacy of the IR REHAB machine for the adjunctive treatment of musculoskeletal pain .
"Musculoskeletal pain is a challenging condition for both patients and physicians. Many adults have experienced one or more episodes of musculoskeletal pain at some time of their lives, regardless of age, gender, or economic status. It affects approximately 47% of the general population. Of those, about 39-45% have long-lasting problems that require medical consultation. Inadequately managed musculoskeletal pain can adversely affect quality of life and impose significant socioeconomic problems."
Monitoring Plan
The study is classified as a minimal risk trial of short duration therefore a detailed plan for monitoring the data for participant safety is not required.
Data Storage and Security
All individuals participating in the trial will be assigned a participant number. Subsequently all clinical records and reports will reference only the participant number, ensuring that participants remain anonymous.
Because of the low number of trial participants, only paper records will be maintained for all clinical and personal data. Records will be kept in locked storage and physical access will only be on a need to know basis. A participants' personal data correlating the participating individuals name and the trial participants Identifying Number will only be available to the principal investigator, clinical staff, and the trial administrator. All analytics will be performed on securely encrypted devices using only data masked or redacted of any personal information.
Risk/Benefit Assessment
Applying the test for the determination of risk established by the FDA Regulation referred to as the "Common Rule" found in 45 Code of Federal Regulations (CFR) 46, Subpart A the rule states;
"Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
The researchers have determined that only a minimal risk is presented to participants of the trial.
All persons interviewed for the trial will be selected using the established invisaRED Technologies IR REHAB guidelines for indications and contraindications. Combining the guidelines for indications and contraindications with the thorough classroom review and "hands on training " for clinicians who will be conducting the trial, the risk is best compared to exposure to sunlight.
Subjects of the study receiving the invisaRED Technologies IR REHAB therapy may receive the following benefits:
- Open up blood vessels to ease swelling
- Help the immune system create more chemicals that heal tissue
- Build more connective tissue in injured area
- Trigger endorphins, natural hormones that ease pain
- Drug free therapy without a chance of addiction
- The therapy is noninvasive
- There are no known side effects
Subject Identification, Recruitment And Consent/Assent
At roadway intersections in close proximity to the research facility signs will be erected containing the verbiage: "Pain and Injury Study, No Cost, Call 770 988-5594" in order to recruit study volunteers from the community.
The clinic's primary care patients will also be provided an opportunity to volunteer for consideration as a trial participant.
The primary investigator will conduct all subject interviews and obtain informed consent. A thorough disclosure of all clinical process, contraindications, and any risk will be discussed with candidates for the trial.
There shall be no cost incurred by candidates for inclusion in the study or individuals selected to participate in the study.
No monetary remuneration will be offered participants in the study. However a commensurate number of treatments with the "as usual" IR REHAB device will be offered for free to those patients who received treatment using the sham device at the conclusion of the clinical trial. This will provide the participants treated with the sham device the opportunity to undergo therapy using an activated IR REHAB device.
Requirements for Human Subject Protection Training
The Primary Investigator and clinical associates conducting the trial will complete the Collaborative Institutional Training Initiative (CITI) course Good Clinical Practice (GCP) for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The trial will compare results between two groups; the first will be treated using the invisa-RED Technology IR REHAB and the second group with a sham device. The trial will be conducted employing a single blind study methodology; participants will not know to which trial group they have been assigned. Participants will undergo six (6) therapy sessions each using a standardized 15 minute protocol. At each of the therapy sessions; the participant will be asked to record their pain level before the treatment session and then in the same manner after the treatment using a Visual Analog Scale (VAS). The results from the two groups will be statistically analyzed to determine the efficacy of the invisa-RED Technology IR REHAB as an adjunctive therapy for musculoskeletal pain. Any medical errors will be included in the statistical analysis.
| Arm | Type | Receives |
|---|---|---|
| IR REHAB Device | Experimental | Device: IR REHABParticipants will receive 6 treatments of 15 minutes each with an active IR REHAB device over the period of three weeks. |
| Sham Device | Sham comparator | Device: ShamParticipants will receive 6 treatments of 15 minutes each with a disabled (sham) IR REHAB device over the period of three weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The number of participants is projected to be thirty (30).
- There will be an equitable distribution of male and female participants.
- Women who are pregnant, trying to get pregnant, or nursing will be excluded from the study, as they should not receive Low-level Laser Therapy (LLLT). There is no evidence of harm to a an unborn baby however there have been no safety tests either, so for medical legal reasons we recommend never treating such individuals.
- The participants will be 18 years or older.
- The ethnicity of the participants will be equitably distributed.
Key exclusion criteria (17 listed)
- If you are pregnant, trying to get pregnant or nursing laser light therapy should be received only after the end of these conditions. There is no evidence of harm to a an unborn baby however there have been no safety tests either, so for medical legal reasons we recommend never treating areas directly over a developing child.
- Individuals with hypertension, light sensitive epilepsy, cancer, heart disease, infectious skin disease, and severe varicose veins should not use this device.
- People suffering from infectious and acute disease such as a fever should not use this device.
- People who have hemorrhagic disease, vascular ruptures, skin inflammation, or any disease of the skin should not use this device.
- Person with a history of lentigines, an autoimmune vascular disease that causes color changes in the legs or arms due to obstruction or stenosis of blood vessels.
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 |
|---|---|---|
| IR REHABParticipants undergo therapy sessions with active, dual frequency, low level laser therapy device | Device | IR REHAB Device |
| ShamParticipants undergo therapy sessions with disabled device producing no laser energy | Device | Sham Device |
Primary outcome
Measured Change in the Participants Pain Levels
Time frame: Participants pain levels will be recorded over a period of three weeks.
Participants pain levels will be measured using a visual analog scale of 0-100mm where a smaller number indicates a lower perceived pain level and a larger number indicates a higher level of pain. The participant will personally manipulate a visual analog scale with a manual slide indicator to record their pain levels
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33575952El-Tallawy SN, Nalamasu R, Salem GI, LeQuang JAK, Pergolizzi JV, Christo PJ. Management of Musculoskeletal Pain: An Update with Emphasis on Chronic Musculoskeletal Pain. Pain Ther. 2021 Jun;10(1):181-209. doi: 10.1007/s40122-021-00235-2. Epub 2021 Feb 11.
- Individual participant dataSharing planned: No
Related trials for Nociceptive Pain
RecruitingPhase 4
Anrikefon-based Patient-controlled Intravenous Analgesia Following Laparoscopic Surgery
Laparoscopic Surgery, Visceral Pain, Postoperative
Not yet recruiting
Effects of Music During Walking on Pain and Muscle Activation in People With Chronic Pain Due to Knee Osteoarthritis
Knee Osteoarthritis
Not yet recruitingObservational study
Evaluation of Consciousness Depth (qCON) and Analgesia Depth (qNOX) Indices in General Anesthesia
Cesarean Section (MeSH: D002585), Anesthesia
RecruitingObservational study
Overlapping Pain Trajectory Study
Migraine, Musculoskeletal Pain
Not yet recruiting
TAP vs. ESP Blocks for Post-Cesarean Analgesia
Postoperative Pain After Cesarean Section
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.
Ajibole Abatunde, MD principal investigator
Midnight Rose LLC dba Abbycare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IR REHAB in people with Nociceptive Pain and Musculoskeletal Pain, run by IR Technology, LLC 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 6 inclusion and 17 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 18 Mar 2025. 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. 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 18 Mar 2025). 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?
Measured Change in the Participants Pain Levels (time frame: Participants pain levels will be recorded over a period of three weeks.). 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 NCT06393088, which also lists 1 linked publication.
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 18 Mar 2025.