The Instant Verification System™ - Document unpredicted events in real time.
Warning: technical jargon ahead and formatted for computer screens
The Instant Verification System (IVS) provides photobiomodulation therapy (PBM) researchers and clinicians with the ability to record sessions in real-time, on a millisecond timescale. The recorded data, in fine temporal and spatial details, may help answer new questions. Looking for some new areas to explore?
We hope that a brief history of the IVS development sparks your imagination.
The Vari-Chrome® Pro - No Missing Wavelengths
The versatility of the Vari-Chrome® Pro opens research and care with selected visible wavelengths, a few wavelengths at a time.
The Vari-Chrome Pro lets the practitioner efficiently find the wavelengths needed by the patient. The practitioner may now select from 270 wavelengths, with no missing wavelengths.
The Instant Verification System records the wavelengths applied in real time along with data from cameras and sensors.
Each treatment works like a mini-study with its recorded responses and outcomes, or not.
If at first you don't succeed, then try a different wavelength...
Which wavelengths may the injury need to resume its healing?
The Instant Verification System opens efficient means for examining relationships among multiple disorders, responses, and outcomes within the SAME person during a SINGLE visit.
Could each injury respond to a particular wavelength or wavelengths?
Might you expect each injury to resume healing on it own schedule?
PhotoMed's feasibility studies suggest that some injuries may be interdependent. For example, non-healing wounds have been recorded to resume healing upon the release of "nothing works" chronic pain at a different site. That is, the wound had not been directly treated before its healing had resumed.
Because the body does its own healing, could the therapy "merely" press a restart button?
How many different restart buttons might prompt healing of a single injury?
A few factors that form that basis for deciding which wavelengths might efficiently restart healing.
Could the skin be the sensor for prompting healing to resume?
Varying the wavelength during therapy may overcome the problem that the needed wavelengths aren't known in advance of a measurable physiological response.
Each wavelength may interact with molecules in specific cells. But which cells need the photonic energy? Wavelengths in the blue, green, and yellow don't penetrate the skin as deeply as red.
Might the responses from many cells in the skin to different wavelengths compete and perhaps cancel the effects? Might that make room light boring to the body?
Different tissues and sensors in the skin respond to different wavelengths as they absorb photons. The molecules select the photon to absorb, or not.
Like for your eyes, skin has adapted to sense tiny variations across vast ranges of intensity. Intensity beyond some level can't be uniquely detected.
The practitioner typically positions the beam from the Vari-Chrome Pro to keep the maximum intensity within the normal sensing range of the skin (direct sunlight on the skin).
Some lasers and LED wavelengths are chosen to "penetrate" the skin. Might the skin work like welding goggles if the intensity of the photons is 500x that of sunlight (for the specific wavelength)?
Not sure that you skin can "see" light? Consider that LED illumination may be called "cool" or "warm" depending upon the ratio of red and blue wavelength intensities. The warm and cool designations are opposite to how a welder thinks about "white" or "red" hot.
Non-invasive therapies - could the outcomes be hard to believe?
The outcomes from non-invasive therapies don't appear to fit the "need another dose" paradigm. The return to normal functioning isn't expected. The resulting "zero" dose makes it hard to calculate a dose-response relationship.
It took tons of data, collected over 20 years, to identify patterns in the return to normal healing or functioning. Unsurprising, invasive interventions and non-invasive therapies "work" on different people.
Unsurprising now, healing is what the body does, not the therapy.
The key concept was to replace the subjective abstractions of "acute & chronic" with objectively measurable "healing & not-healing".
Might the Quick Events suggest that healing had stalled at the last step?
The language used by rehabilitation specialists includes the concepts of normal healing and the return to normal functioning. The Ouick Events begin and complete during a visit that may be recorded in real time.
The data kept circling back. Lots of different wavelengths appeared to prompt the desired relief or improved functioning.
The quick events felt like "anecdotes" for their unexpectedness whether from the Vari-Chrome Pro or another non-invasive therapy.
Some patients reported, I can't believe what just happened.
Other patients reported, I feel better.
Could nature videos suggest a solution?
The team's anesthesiologist and neurologist advisors were puzzled. Stories about the outcomes felt like anecdotes. More data please.
The Instant Verification System™
PhotoMed's team of engineers implemented conventional industrial quality-improvement strategies that recorded events, objective responses, and outcomes during each visit. Each 2-minute treatment contributed response and outcomes data whether it prompted a response, or not.
The engineers weren't scientists or doctors, but they understood that measuring TIME would be a key to improving efficiency - their task.
The team focused on physiological responses and outcomes to overcome the limitations imposed by the subjective nature of pain. Also, that pain relief often occurred after the visit ended. Trying to connect the dots between visits was too complicated.
The engineers developed all-electronic study management systems that recorded events in real time.
The Instant Verification System digitally records events as they unfold with the TIME captured to the millisecond.
Like a video referee, the real-time recordings present events with fine temporal and spatial details. The recorded data may be replayed to test insights and to help answer entirely new questions.
The modular system manages study patient's narratives, records appropriate sensors, and cameras, and supports scrolling playback.
Some crazy-fast responses forced the engineers to think in terms of "events". Zero time.
Record physiological responses that occur during therapy
The engineers thought that it was cool for hands to resume warming after 30 years of persistent coldness. Sometimes on the first try! The called that a homerun.
Thermal imaging lets the practitioner monitor the patient's skin temperatures. Patients with persistently cold limbs typically remark that they can feel the cold "leaving" before mentioning that their fingers may be warming. Lighter gray is warmer.
Thermal imaging supplied the early data needed to develop the Vari-Chrome Pro. Certain wavelength ranges were found to be more efficient at prompting a return to comfortable regulation.
Of course, the electronic sensors must be appropriate for the particular impairments. Thermal imaging provides a non-contact means for recording continuous measurements. Other measurement may necessarily be available only on a before/after basis.
The data in the thermal images may be re-examined to answer new questions. For example, what may be the lag time between the response and when it becomes measurable. Clue: the veins across the back of the hand get colder (darker).
A neurologist found that she could observe a "pupillary response" at the moment when warming begins. The response is her cue to stop therapy.
Real-time recordings - replay quick events
The Instant Verification System evolved to capture unpredicted quick events while testing the Vari-Chrome Pro.
Today, the quick events make sense from a software engineer's "if/then" switching perspective. Couldn't the events mark the return to normal functioning if the body was waiting at the very last step of healing?
The team focused on the physiological responses that occurred during each visit.
The examples show a few quick events:
The number of years in the not-healing state doesn't appear to limit the return to normal functioning, for some people.
Counterintuitive, is appears that the unmanageable pain and impairments can switch back to normal functioning or normal healing.
Real-time recordings - Connect the Dots...
The growing library of recorded physiological responses provided an economical means of comparing the outcomes from the new therapy with the earlier failed interventions.
However, the comparisons show the challenges of testing new non-invasive therapies that may prompt the return of normal functioning:
The injury may return to normal functioning only one time and then remain normal for a lifetime with no other therapy needed.
The data confirmed that different wavelengths could prompt healing responses, such as warming for painfully cold hands. The needed wavelengths appear to be personal rather than absolute for a type of injury.
The treatment sites may be different from the problem area, like with acupuncture.
Real-time data and recordings may help answer new questions. The practitioner may monitor physiological functions, such as warming, to support their treatment decisions.
Could the finding of a "dose response relationship" be impossible when the dose drops to zero?
Warning: technical jargon ahead, formatted for computer screens
Why focus on patients with “nothing works” impaired functions and pain?
Editor's note: we are using the terms "nothing works", "treatment-resistant", and "unmanageable" interchangeably. These terms imply that interventions were tested but failed, or that no intervention previously exist to restore functioning for the impairment. Please suggest terms and metaphors that may improve communications.
In 2000, a few wavelengths in the red and infrared spectrums were prompting amazing relief from horrible pain syndromes. However, the therapies were inefficient for the required practitioner knowledge, clinical experience, and clinic time.
Patients with "unmanageable" types of pain and impaired functioning appeared to switch back to normal in zero time. Patients with "managed" chronic pain didn't respond that way.
Starting with a zero expectation of improvement in functioning made it easier to detect whether a specific 2-minute stimulation by the therapy works, or not.
The reports of pain relief often arrive too late to support the practitioner's decision making, or to record the event during the visit.
It took years of real-time data and recordings to find the "unmanageable" or "nothing works" characteristic that increased the likelihood of success.
Could the chronic pain be waiting for a signal?
The team was lucky, excluding the patients with "nothing works" chronic pain would have limited the utility of the Vari-Chrome Pro.
The team was lucky again that unrelenting "nothing works" chronic pain may have healed except for the last step.
Could the pain experience be waiting for a distraction or an "all clear" signal?
Could the variable wavelength therapy provide a different signal every millisecond?
Why focus on the quick events?
The return to normal functioning may feel impossible after years of "nothing works" chronic pain.
However, doesn't the "chronic" clock begin after most injuries have healed?
Wouldn't the quick events likely occur unnoticed during the normal healing phase?
The software engineers suggest that the quick events mark some cool if/then branch in the body's computer programs. The view the not-healing to healing switch as a logic problem not a medical impossibility.
The common feature is the switch-like return to normal functioning or the resumption of normal healing in the Quick Events that improve the functioning of the sensory, motor, abnormal skin temperatures, and non-healing wounds systems.
The return to normal functioning may feel impossible after years of "nothing works" chronic pain. But haven't most injuries healed before the "chronic" clock begins?
Could "null hypothesis" testing confirm that the therapy "works"?
The team reasoned that starting with patients who did not achieve relief from earlier interventions might provide “comparison arms” without the cost. Some of the previous tests include pain-masking medications, electronic spinal cord stimulators, and deep brain stimulators. Each test "rules" out some reasons for the presences and intensity of pain or the impaired functioning. Ultimately, the failed attempts lead to terms such as "nothing works", "treatment-resistant", or "unmanageable".
A basic “null” hypothesis suggested that; the new therapy won’t “work” better than any earlier intervention.
When the patient's functioning improved, the hypothesis failed!
The failures were good because each failure of the hypothesis suggested that the therapy “works”. The patient's surprise confirmed that the improved functioning wasn't expected.
The recording systems captured events that challenge notions about chronic pain and impaired functioning.
The earlier failed interventions ruled out known causes for the chronic pain. Counterintuitively, this filtering improved the likelihood that a non-invasive therapy might prompt healing to resume.
Each 2-minute treatment tested the null hypothesis compared with every earlier intervention tested by the patient.
With more than 500 volunteers, there were no adverse side effects. The most common side effects were improved sleeping and overcoming the notion that the pain would never leave.
Could the therapy "work" but be missed based upon 0-10 pain scores?
The Instant Verification System recorded unexpected responses and outcomes that may affect studies that prompt quick effects.
Real-time recordings and data show that reports of pain relief often do not match the measured improvement in functioning. For example, a significantly improved range-of-motion of the neck and head but the reports of pain relief did not always improve during the visit.
How might that occur? A long story made short, the team and advisors found that the patients shrank their "10" standard after therapy (Time 3) relative to the time immediately before the therapy (Time 2). The result is that the residual pain remains a proportional "6/10".
The key question after therapy was, are you using the same "worst imaginable pain for your "10" as before the therapy? The typical answer was; I can't imagine that "worst imaginable pain" anymore. Curiously, the same problem occurred with multiple sources of pain and impairment in the same person that resolved during a single visit or during different visits.
The problem was first noticed when people with complex regional pain syndrome (CRPS or RSD) experienced their hands warming up and their pain subsiding. Later the team learned about the concept that the warming only shows the first signs of the return to normal functioning. PhotoMed's feasibility studies relied on objective measures of functioning and the relative timing.
The feasibility studies included the collection of pain data, such as with a McGill SF questionnaire. Unfortunately, typical pain "measurement" questionnaires collect data for a single source of pain. PhotoMed's studies tracked multiple impaired functions in parallel in the same person during a visit. Multiple impairments typically resolved at separate times with apparently independent lag times for reports of pain relief.