Clinical Trial to Establish the Safety and Efficacy of the invisaRED® IR REHAB Device When Used as an Adjunctive Therapy for Nociceptive Musculoskeletal Pain
Phase: NA
Conditions: Nociceptive Pain, Musculoskeletal Pain
Sponsor: IR Technology, LLC

invisa-RED IR REHAB™ FDA 510 K  
Clinical Trial Protocol, Statistical Analysis Plan,  
Results, and Conclusions 
Clinical Trial to Establish the Safety and Eﬃcacy of the IR REHAB Device  
When Used as an Adjunctive Therapy for Nociceptive Musculoskeletal Pain 
FDA Study NCT06393088 
December 10, 2024 
Sponsor: 
Stephen Joseph Reardon IR 
Technology LLC 
(404) 573-8993 
Investigator: 
Dr Ajibola Babatunde 6380 Bells 
Ferry, suite 107 
Acworth, GA 30102 

invisa-RED IR REHAB Clinical Trial Protocol 
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 nociceptive 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. 
Background 
“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.”1 The invisaRED® IR REHAB 
has been developed to deliver adjunctive pain therapy for musculoskeletal pain. 
Criteria for Participants 
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 nociceptive 
musculoskeletal pain. 
 
1 El-Tallawy, Salah N et al. “Management of Musculoskeletal Pain: An Update with Emphasis on 
Chronic Musculoskeletal Pain.” Pain and therapy vol. 10,1 (2021): 181-209. doi:10.1007/
s40122-021-00235-2 

Subject Qualiﬁcation 
No candidates of diminished capacity will be considered for inclusion in the trial. 
Capacity is a functional assessment and a clinical determination about a speciﬁc decision 
that can be made by any clinician familiar with a patient’s case. The four key components 
addressed during the candidates capacity evaluation include: 1) communicating a choice, 2) 
understanding, 3) appreciation, and 4) rationalization/ reasoning. 
No monetary remuneration will be oﬀered participants in the study. At the conclusion of the 
clinical trial, and upon approval by the FDA, a commensurate number of treatments with the 
IR REHAB device will be oﬀered to those patients who received treatment using the sham 
device. This will provide the participants treated with the sham device the opportunity to 
undergo therapy using an activated IR REHAB device. 
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 increase circulation and ease swelling 
•
Help your immune system create more chemicals that heal tissue 
•
Build more connective tissue in injured area 
•
Trigger endorphins, natural hormones that ease pain 
•
Drug free alternative without a chance of addiction 
•
Noninvasive therapy 
•
No known side effects 
Criteria for Participants: 
Participants will be taken from a random population of respondents to email and social 
media recruitment, in person oﬀers to participate to existing patients, and individuals in the 
community who have seen signage advertising the trial. The number of participants is 
projected to be thirty  (30). There will be an equitable distribution of male and female 
participants. The participants will be older than the age of 18 years. Inclusion criteria will be 
individuals that may beneﬁt from an adjunctive therapy for nociceptive musculoskeletal 
pain. 

Exclusion criteria will include the following: 
• For women who 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 an unborn baby however there have been no safety tests either, so for 
medical legal reasons we recommend against treatment during these times.  
• Individuals with uncontrolled 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. 
• 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. 

Exclusion Criteria - continued 
• 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. 
Subject Identification, Recruitment And Consent/Assent 
At roadway intersections in close proximity to the Abbycare/IR Medical Centers Clinic located 
at 1105 Parkside Ln, suite 1300, Woodstock, GA 30189 ro a d  s i d e  s i g n s  will be erected 
containing the verbiage: “Pain and Injury Study, No Cost, Call 770 988-5594”   
This will be done 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. All candidates will be older than the age of majority in 
the state of Georgia (18 years old). There shall be no cost incurred by candidates for inclusion 
in the study or individuals selected to participate in the study. 
Methods and Procedures 
The trial is designed to prove the eﬃcacy and safety of the invisa-RED Technology IR REHAB 
device when used as prescribed as an adjunctive therapy for musculoskeletal pain . 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 (placebo) device. 
The trial will be conducted employing a single blind study methodology; participants will not 
know to which trial group they have been randomly assigned. Participants randomly selected 
for the control or Sham (placebo) Group will undergo therapy sessions with a disabled IR 
REHAB device producing no laser energy, however, this sham device will power up the 
console and fans to appear to be operating normally. If a participant questions the eﬃcacy of 
the sham device, an assertion may be made that only a near infrared, non-visible frequency of 
light, is being employed. The control group receiving treatments using the sham device will be 
scheduled for treatment at times other than participants who will undergo therapy sessions 
with the fully functioning device in order to ensure the trial blind.  
All participants will undergo treatments 2 times weekly for 3 weeks. Treatment will be 15 
minutes each session. For each 15 minute session a singular adjustment to the laser’s power 
output will be made based on the participants standard Fitzpatrick Skin Type. This power 
adjustment ensures optimal photonic energy absorption, enhanced eﬃcacy, and participant 
safety. The minimum time between any participants’ scheduled treatments will be 48 hours.   

Methods and Procedures - continued 
Prior to each therapy session the participant will be asked to record their pain level using a 
Visual Analog Scale (VAS) and then in the same manner after each treatment using the same 
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 
nociceptive musculoskeletal pain. Any medical errors will be included in the statistical 
analysis. 
Data Analysis and Data Monitoring 
The mean change in each group of participant’s pain levels as recorded at the trials beginning 
and then at the trials conclusion will be statistically evaluated using a two-tailed independent 
sample T-test with an a priori threshold p value of < (less than) 0.05. 
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 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. 
We have determined that only a minimal risk is presented to participants of the trial 
See the detail minimal risk criteria analysis below: 
I) The device is NOT intended as an implant that presents a potential for serious risk to 
the health, safety, or welfare of a subject. The invisa-RED IR REHAB employs no 
implanted devices as part of any treatment or therapy. 
II) The device is NOT purported or represented to be for a use in supporting or 
sustaining human life that presents a potential for serious risk to the health, safety, or 
welfare of a subject. 
III) The invisa-RED IR REHAB is only to be used as directed as an adjunctive therapy for 
nociceptive musculoskeletal pain and is not represented or employed as a life sustaining 
device or therapy. 

Risk/Benefit Assessment - cont. 
IV) The device is NOT for a use of substantial importance in diagnosing, curing, 
mitigating, or treating disease, or otherwise preventing impairment of human health 
that presents a potential for serious risk to the health, safety, or welfare of a subject. 
V) The invisa-RED Technology IR REHAB is to be used only as directed as an 
adjunctive therapy for nociceptive musculoskeletal pain.  
VI) The device does NOT otherwise present a potential for serious risk to the health, 
safety, or welfare of a subject. 
VII)The invisa-RED IR REHAB is classiﬁed as an FDA Class II device and has passed all 
FDA electromagnetic compatibility (EMC) standards. 
VIII)The invisa-RED IR REHAB device employs Class 3b laser diodes in a system of 
“paddles” each containing multiple diodes. Class 3B lasers are hazardous for eye 
exposure; therefore during therapy protective eyewear is prescribed for staﬀ, the 
individual undergoing treatment, and any others in the room. Eye safety is further 
enhanced by standardized invisa-RED Technology IR REHAB clinical procedures, 
which are designed to eliminate exposure of the eyes of the patient and any 
proximate individuals to direct laser light. IR REHAB clinical procedures which are 
found in the manual and are stressed as mandatory during user training dictate that 
the paddles are to be 1) placed on the area to be treated, 2) secured if required, and 
then and only then 3) the system is activated and treatment begun. This greatly 
reduces the chance of any direct laser light entering the eye. Class 3B lasers can 
heat skin and materials but are not considered a burn hazard. Treatment protocol 
standards do dictate power settings be adjusted for the patient’s Fitzpatrick Scale 
skin type; as diﬀering skin tones result in a variance in their coeﬃcient of absorption 
of photonic energy. If these recommendations are not followed the therapy may 
result in skin sensitivity.  Additionally each patient is asked to verbally attest to his or 
her comfort level at the start of each therapy session and further instructed to notify 
staﬀ of any skin discomfort at any time during the treatment. 
Staﬀ and Investigator Training and Certification 
All staﬀ involved in conducting the clinical trial will undergo training and be certiﬁed on the 
use, safety, and clinical procedures of the invisa-RED Technology IR REHAB device. The 
Primary Investigator and clinical associates conducting the trial will also successfully 
complete the Collaborative Institutional Training Initiative (CITI) course GCP for Clinical Trials 
with Investigational Drugs and Medical Devices (U.S. FDA Focus). 

Statistical Analysis Plan 
for the clinical study 
“Clinical Trial to Establish the Safety and Eﬃcacy of the IR REHAB Device When Used 
as an Adjunctive Therapy for Nociceptive Musculoskeletal Pain” 
FDA Study NCT06393088 
Study Research Questions 
Research Question: 
Is there a statistically signiﬁcant diﬀerence in nociceptive musculoskeletal pain after 
therapy with the IR REHAB device as compared to a sham (placebo) device when 
used in an approved and standardized clinical protocol? 
Null Hypothesis: 
There is not a statistically signiﬁcant diﬀerence in nociceptive musculoskeletal pain when 
using an IR REHAB device when compared with a sham (placebo) device as a therapy in 
an approved and standardized clinical protocol. 
Alternative Hypothesis: 
There is a statistically signiﬁcant diﬀerence in nociceptive musculoskeletal pain when 
using an IR REHAB device when compared with a sham (placebo) device as a therapy in 
an approved and standardized clinical protocol. 
Data Sets/Populations 
Criteria for Participants: 
Participants will be taken from a random population of respondents to email and social 
media recruitment, in person oﬀers to participate to existing patients, and individuals in the 
community who have seen signage advertising the trial. 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). Note; there is no 
evidence of harm to 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 older than the age of 18 years. Inclusion criteria will be individuals that may beneﬁt from 
an adjunctive therapy for nociceptive musculoskeletal pain. 

Exclusion criteria will include the following: 
• For women who 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 an unborn baby however there have been no safety tests either, so for 
medical legal reasons we recommend against treatment during these times.  
• 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. 
• 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. 

Exclusion Criteria - continued 
• 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. 
Analysis 
To examine the research question, independent sample t-tests using the statistical analysis 
program IBM SPSS ver.30 will be conducted on the data set. The data set will be comprised of 
comparative results from the two trial groups, the Care as Usual Study Group and the Sham 
(placebo eﬀect) Study Group. The tests will be bootstrapped to a test size of N=20,000 for 
validation. 
An independent samples t-test is the appropriate statistical test when the purpose of research 
is to assess if diﬀerences exist on a continuous (interval/ratio) dependent variable by a 
dichotomous (2 groups) independent variable. The continuous dependent variable to be 
tested is the change in pain level of the joint or body area treated during the clinical trial. Each 
participant will be asked to indicate on a standard 100mm Visual Analog Scale their pain 
levels before the ﬁrst treatment and after each of the prescribed treatments. The diﬀerence 
between the initial pain level of a participant and the level of pain indicted after their sixth and 
ﬁnal treatment will be statistically analyzed to determine if there is a signiﬁcant diﬀerence 
between those in the Care As Usual Group and the Sham (placebo) Group. 
The dichotomous independent variables for the data set is the change in pain level of each 
participant in the group treated with the invisa-RED Technology IR REHAB Low-level Laser 
Therapy (LLLT) device and the group treated using the sham (placebo) device as a therapy in 
the standardized clinical protocol. The assumptions of normality and homogeneity of variance 
will be assessed. Homogeneity of variance assumes that both groups have equal error 
variances and will be assessed using Levene’s Test for the Equality of Error Variances. Each t-
test will be two tailed with the probability of rejecting the null hypothesis when it is true set at 
p < 0.05. This ensures a 95% certainty that the diﬀerences did not occur by chance. Data 
produced by both groups will be the results of a clinical trial governed and conducted as a 
randomized single - blind study using an IRB approved clinical protocol. 
Requirements for Human Subject Protection Training 
The Primary Investigator and clinical associates conducting the trial will complete the 
Collaborative Institutional Training Initiative (CITI) course GCP for Clinical Trials with 
Investigational Drugs and Medical Devices (U.S. FDA Focus). 

Recruitment 
The Trial recruitment period had a start date of July 22nd and ended on August 7th 2024. (A 
total of 17 days) All participant recruitment and interviews were conducted at the Abbycare 
Clinic in Woodstock, GA. 
Reporting Groups  
The ﬁrst was the IR REHAB Group which was a randomly selected group of sixteen (16) 
participants who received treatment per the prescribed trial protocol using a fully functional 
invisa-RED Technology IR REHAB device. Treatment protocol is as follows: Participants will 
undergo six (6) therapy sessions of 15 minutes each over a three week period. Power settings 
will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power 
setting of 7 was used, for skin types iii and iv a power setting of 6, for skin types v and vi a 
power setting of 4 was employed. Each participant randomly assigned to the IR REHAB 
group underwent six therapy sessions over three weeks using a fully functional invisa-RED 
Technology IR REHAB device. 
The second group was the Sham Group which was a control group of thirteen (13) randomly 
selected participants who received a placebo treatment per the prescribed trial protocol using 
a non functional IR REHAB device. (The sham device was disabled and delivered no Low-level 
Laser Light energy during therapy but appeared to be fully functioning and powered-up.) 
Treatment protocol was as follows: Participants underwent six (6) therapy sessions of 15 
minutes each over a three week period. Power settings were input based on the participants 
Fitzpatrick Scale skin type as per usual. For skin types i and ii a power setting of 7 was input, 
for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 was 
utilized. Each participant randomly assigned to the "Sham Group" underwent six therapy 
sessions over three weeks using the sham (non functioning invisa-RED Technology IR 
REHAB) device. 

Participant Flow: 
 
Baseline Characteristics: 
Outcome Measures: 
 

Outcome Measures - continued: 
 
Adverse Eﬀects Overview: 

Graphs Depicting Results: 
 

Graphs Depicting Results - continued: 
 

Graphs Depicting Results - continued: 
 

Study Results 
The “Clinical Trial to Establish the Safety and Eﬃcacy of the IR REHAB Device  
When Used as an Adjunctive Therapy for Nociceptive Musculoskeletal Pain” 
FDA Study NCT06393088, was 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 
single blind trial of two groups; one group treated as usual, the other treated using a sham 
device. At the conclusion of the trial; results from the two groups were statistically analyzed to 
determine the eﬃcacy and safety of the invisa-RED® IR REHAB machine for the adjunctive 
treatment of nociceptive musculoskeletal pain. 
The study was designed as a superiority trial with a null hypotheses which asserted, in the 
population where the sample was obtained there was no diﬀerence between the 
intervention (IR REHAB) and placebo (Sham Device) groups in the mean change in the primary 
outcome variable: 
However, the results of a bootstrapped (N=20,000) independent samples 2 sided t-test 
revealed: 
An estimated mean diﬀerence (net value) of 41.67% greater reduction in 
participant’s pain level when using the invisa-RED® IR REHAB as compared to 
the Sham Device this with a 95% conﬁdence level from 20.15% to 61.67% and 
a two tailed P value < 0.01. 
Therefore by conventional criteria the results are considered to be statistically 
signiﬁcant for the trial's primary outcome variable, disproving the null hypotheses 
and aﬃrming the alternative hypotheses that there exists an interventional superiority of the 
invisa-RED® IR REHAB therapy over the Sham Device (placebo). 
Additionally and of great signiﬁcance, there were zero adverse eﬀects or mortality reported 
during or after the the clinical trial. 

Three additional bootstrapped analysis (N=20,000) of the data were conducted: 
1) An independent samples eﬀect size analysis was conducted using Cohen’s d and 
resulted in a value of 1.44, which by convention indicates a large eﬀect size for 
the invisa-RED® IR REHAB over a placebo.  
2)  A Mann-Whitney U test was performed to evaluate whether results diﬀered by 
treatment group. The results also indicated that the group treated with the invisa-
RED® IR REHAB had signiﬁcantly greater pain reduction than those treated with 
the Sham Device,  z = [-3.12], p = [<0.01]. 
3) Levene’s test showed that equal variances for the IR REHAB and Sham Device 
Groups may be assumed, F(1,27) = .006, p = .936. 
Conclusions That May Be Drawn From The Study 
A conclusion may be made that there is an interventional superiority of the invisa-RED® IR 
REHAB over a Sham (placebo) device when employed as a therapy for the adjunctive 
treatment of nociceptive musculoskeletal pain, and that the invisa-RED® IR REHAB when 
used as directed is both clinically safe and eﬀective.