The Instant Verification System™ - Document unpredicted events in real time.
Warning: technical jargon ahead and formatted for computer screens
The Instant Verification System provides photobiomodulation therapy (PBM) researchers and clinicians the ability to record sessions in real-time, on a millisecond timescale. The recorded data may help answer new questions.
The research methods follow a standard delayed entry style. For the “nothing works” patients, the control arms have been tested, failed, and exhausted.
The Vari-Chrome® Pro - No Missing Wavelengths
The versatility of the Vari-Chrome® Pro introduced challenges to developing it as a product.
The problem was to let the practitioner efficiently select the wavelengths needed by the patient. The practitioner could now select from 270 wavelengths, with no missing wavelengths.
Solving the problem needed new ways to learn how to use that versatility.
The Instant Verification System enabled the recording of previously unexpected quick events.
Would conventional testing one wavelength at a time would be inefficient?
Which wavelengths may the injury need to resume its healing?
Could each cell respond to a particular wavelength or wavelengths?
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). For your eyes, vision on a sunny white beach may be improved by wearing sunglasses that bring the intensity range into a useful range.
For example, non-healing wounds may restart healing upon receiving photonic energy with competing wavelengths filtered out. The arrival of fresh exudates may be seen only at some wavelengths that are absorbed rather than reflected or scattered.
Varying the wavelength during therapy may overcome the problem that the needed wavelengths aren't known in advance of a measurable physiological response.
Non-invasive therapies - how many adjustments may be possible?
Individually testing 270 wavelengths x 1000 frequencies x 22 rates of wavelength variation x 300 treatment locations on the body at 1 iteration per second might take more than 50 years.
(Reducing a galaxy of possible settings to the current 7 pre-programmed settings in the Vari-Chrome Pro took the team 20 years.)
What if the patient was experiencing multiple impairments at the same location? Different locations?
PhotoMed's team of nerdy soft- and hardware engineers developed sophisticated study management systems. The aim was to gather data that might help to make the therapy more efficient. Today, it's called the Instant Verification System.
A few factors that form that basis for deciding which wavelengths might efficiently restart healing.
Non-invasive therapies - could the outcomes be hard to believe?
Another problem with the new therapy was that the responses and outcomes were not predicted and occurred too quickly and completely to easily be believed.
Couldn't versatility be a curse if you were trying to prove that doing one thing always produces the same outcome?
The Vari-Chrome Pro delivers an efficient means for finding wavelengths that work for the individual injury.
Of course, healing is what the body does, not the therapy.
The data kept circling back. Lots of different wavelengths could 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.
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™
The team, as engineers, tried to apply conventional industrial quality improvement models based upon real-time recordings of objective responses and outcomes. 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 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.
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?
By 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 "nothing works" types of pain and impaired functioning could appear to switch back to normal. Patients with "managed" chronic pain didn't respond that way.
Observing impaired functioning simplified detection of whether the therapy works, or not. Pain may not respond quickly enough to support the practitioner's decision making.
It took years of real-time data and recordings to find the "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 similarity of the return to 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.
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 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.
What if you changed "chronic" to "not healing"?
We're embarrassed that we didn't believe the patients when they blurted out; I feel normal again.
It was beyond the team's imaginations that sensations and movements could instantly switch back on to "normal". The problem was that the notion of "chronic" doesn't suggest the possibility of reversibility. Especially after years of impairment.
The concept that the body could "return to normal functioning" in a quick event just didn't feel possible. However, the team tried, and failed, to fit the data into models for pain-masking medications.
Could the abstract time-related notions of "acute" and "chronic" deflect thinking about the underlying processes of "healing" and "not healing"?
Unsurprising, don't many non-invasive therapies aim to prompt the body to return to its normal functioning? The Instant Verification System records the physiological responses that mark the return to normal functioning events.
In 2018, friends in the physical medicine and rehabilitation specialties presented the answer. They suggested that the therapy prompts the impaired functions to return to the "acute" or healing state. The body does the rest.
Like with many non-invasive therapies, the practitioner, the patient, and the Vari-Chrome Pro work together to efficiently prompt the body to resume healing itself.
Could the quick events occur when the healing had stalled at the last step?
The Instant Verification System may be configured to save time and $$ for research into the underlying phenomena.