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Worldwide, pain and pain-related diseases are the leading causes of
disability and disease burden. In the United States, pain is the most
common reason patients consult primary care providers and an
estimated 100 million people live with pain everyday [1]. Acute,
chronic, and mild to moderate pain issues are widely prevalent
throughout the US and have been shown to impact quality of life
and activities of daily living (ADLs) [2-4].
In recent years, several medical associations have updated their
guidelines for pain management and recommend a multi-modal
approach that includes non-invasive and non-pharmacological
therapies as a first line treatment before consideration of other
approaches [5,6]. There has been an effort to minimize the use of
pharmacologic treatments in light of their potential adverse effects
and toxicities. As we progress, it is important to investigate novel
nonpharmacologic treatment options for patients as part of a multimodal treatment approach to maximize effectiveness, improve a patient’s quality of life (QoL), and restore function. A variety of
non-pharmacologic treatments have been reported to be successful
in addressing a patient’s pain with limited, if any, side effects.
These include physical therapeutic, behavioral, and topical drug
and device therapies [7-9]. Evidence supports that topical analgesic
therapies are safe and effective for pain conditions and should be
considered as part of a multi-modal treatment strategy [10,11].
Several theoretical frameworks have been proposed to explain the
physiological basis of pain, the most well-known of which is the
Gate Control Theory [12]. Over the past several years, researchers
have developed an understanding of the Neuromatrix Theory of
Pain (NTP) through imaging studies and related theories of how
various peripheral, spinal and brain regions modulate and perceive
pain [13-15]. By extension of the so-called “gate control” theory
of pain, the neuromatrix of pain is a network of neuronal pathways
and circuits responding to sensory (nociceptive) stimulation
[13,16,17]. The neuromatrix theory of pain proposes that pain
is a multidimensional experience produced by characteristic
“neurosignature” patterns of nerve impulses generated by a
widely distributed neural network in the brain [13,16]. These
neurosignature patterns may be triggered by inputs such as tactile
sensations. Tactile perception is an innate mechanism for human
survival and represents our evolved and adaptive somatosensorial
ability to apprehend information via haptics – the active touch
for object recognition and perception by higher centers of the
brain [18,19]. The somatosensory experience is determined by
a set of channels and receptors sensitive to thermal, tactile, and
mechanical stimuli shown to be critical to survival, balance control,
and pain modulation[18-20]. The complex pain neuromatrix, an
explanatory model of how pain is generated and therapeutically
alleviated, suggests that pain originates and is experienced in
specific clusters and patterns within neuronal impulses, which originate from a neural network dubbed “body-self neuromatrix”
[13]. This challenges the theory that pain originates in a noxious
stimulus causing tissue injury or damage, or the “Cartesian model
of pain” [21,22].
The intricate neuronal signals associated with pain are measurable
by the electroencephalogram (EEG) [17,23,24]. Decoding pain
perception using EEG is an advancement that has a wide spectrum
of physiological and pathophysiological ramifications. This reveals
a spatio-temporal signature associated with pain, nociception, and
hyperalgesia. EEG research has shown that haptic vibrotactile
trigger technology (VTT) modulates brain centers that are
associated with pain pathways [25]. In recent years, haptic skin stimulation technology has been incorporated into several over the-counter products with different routes of delivery that include
patches, apparel (socks), braces, wrist bands, and compression
sleeves, among others.
In this pilot HARMONI (Health Assessments: Reviewing,
Measuring, and Observing Neuromatrix Interaction) study,
we evaluate a non-invasive pain-relieving patch (FREEDOM
Super Patch with VTT; Srysty Holding Co., Toronto, Canada)
that incorporates haptic-vibrotactile trigger technology (VTT).
This minimal risk, observational study, evaluated this over-the counter (OTC) non- pharmacological patch that is embedded with
proprietary sensory patterns and incorporating VTT. The patch is
designed to trigger neural pathways and circuits associated with
the neuromatrix of pain and other cortical networks. This study
included patients with mild/moderate/severe, and acute or chronic
pain and evaluated their overall perceptions of pain treatment and
associated symptoms with the use of the VTT pain patch. The Brief
Pain Inventory short form (BPI) tool was used to assess patient reported changes in pain severity and pain interference scores and
change in the use of pain medications at 7- and 14-days following
treatment. Data presented here are on active treatment. Future
planned analyses will include a control and a crossover group of
patients and explore differences between each group.
Methods
Study Design
This study was a prospective, Institutional Review Board-approved
Observational Study aimed at evaluating patients’ experiences and/
or perceptions and patient response for those who have received
a haptic vibrotactile trigger technology (VTT) embedded patch
(FREEDOM Super Patch with VTT; Srysty Holding Co.,Toronto,
Canada) or an inactive pain patch by their clinician. Preliminary
study data presented here include only subjects who received
active treatment.
Baseline Demographic and Clinical Characteristics of Patients
A total of 148 patients (96 females, 52 males) at 3 US investigator
sites were enrolled in the treatment arm of the study and completed
the baseline, day 7, and day 14 surveys. Demographic results were
similar for gender and age at the baseline survey for all groups of
patients. The mean age at baseline was 52.9 years. The primary
pain complaint for the patients was recorded at baseline for all groups. (Table 1). Myofascial/musculoskeletal pain was the most
prominent pain complaint indicated by 54/148 (36.5%) of patients.
Forty-seven (47; 31.8%) patients indicated that neuropathy/
radiculopathy and Arthritis was their primary pain complaint.
Table 1: Primary Pain Complaint (one type, one location, N=148)
Primary Complaint Baseline
Arthritis 47, 31.8%
Neuropathy/Radiculopathy 47, 31.8%
Myofascial/Musculoskeletal 54, 36.5%
At baseline, of the 54 study participants who indicated myofascial/
musculoskeletal pain as their primary complaint, 59% noted that
their hips and lower extremities was the most common location
of pain (n=33), followed by 39% (n=21) of patients indicating
that their neck, back, and shoulders was the area of their pain. Of
the remaining 47 patients who indicated arthritis as their primary
pain complaint, 81% noted their lower extremities (hip, knee, and
foot) was the most common location of their pain (n=38). Almost
30% of patients reported having their pain for 3 months to one
year (43/148) and over 62% reported having pain for more than
one year (93/148). BPI scores indicated that patients receiving the
patch embedded with the haptic vibrotactile trigger technology
(VTT) were experiencing mild (10%; 15/148), moderate (29%;
43/148), or severe pain (61%; 90/148).
Pain management and symptoms were evaluated by patient answers
to validated pain measurement and symptom scales (e.g., Brief Pain
Inventory (BPI)) as well as additional survey questions regarding
patient satisfaction, patient quality of life, and resumption of their
normal activities. Evaluation of a Control Group (CG) of patients
(given an inactive vehicle patch) and a crossover group of patients
(CROSSG) who received the active patch after 14 days of being in
the control group, will also be included in future analyses.
Patients who met the eligibility criteria and who were treated
with the pain-relieving patch comprised the study’s treatment
group (TG). For the treatment group, patient inclusion criteria
were as follows: 1) ages 18 to 85 years, inclusive; 2) ability to
provide written informed consent; 3) received the active VTT
embedded study patch; and 4) had been diagnosed with a mild/
moderate/severe, acute or chronic pain condition. Patients who
had had a history of use drug or alcohol abuse, patients who had
an implantable pacemaker, defibrillator or other electrical devices,
or patients who were pregnant, were ineligible to participate in the
study.
Each site provided patients an identification number, and a
confidential file containing the informed consent forms and
patient identification numbers were kept and maintained in a
secured cabinet only accessible to the principal investigator and
authorized personnel. Patient survey responses were provided with
no identifying patient information.
Patients could withdraw from this study at any time with the
assurance of no unfavorable impact on their medical care. All
diagnostic tests and treatment decisions were made at the discretion
of clinicians, with no tests, treatments, or investigations performed
as part of this study. Patients were provided the treatment at no
cost and were not compensated for their participation in the study.
The study protocol was approved by ADVARRA institutional
review board and was performed in full accordance with the rules
of the Health Insurance Portability and Accountability Act of 1996
(HIPAA) and the principles of the declaration of Helsinki and the
international council of Harmonisation/GCP. All patients gave
informed and written consent.
Topical Intervention
The active, non-invasive, 2 x 2 inch non-pharmacological patches
are embedded with proprietary sensory pattern imprints and
incorporate haptic vibrotactile trigger technology (VTT). The
active patches contain no drug or energy source. There is an
adhesive backing on one side of the active patch. Patients in the
treatment group were instructed to wear one patch near the site
of pain and replace the patch each day (SEE PICTURE 1). The
non-active patches look similar to the active patches but do not
incorporate the haptic vibrotactile trigger technology (VTT).
Duration of Pain Relief
At day 14, patients were asked how long it took for the pain to
return once they removed the patch. Approximately 10% of
patients reported that their pain did not return after they removed
the patch; 44% of patients (65/148) reported that it took longer
than one day for the pain to return after patch removal, and 31/148
(21%) of patients reported that pain was still absent after 2 hours
of removing the patch.
Safety
Patients reported no adverse skin reactions or serious adverse
events while being treated with the pain relief patch.