Biostrap Labs Study Finds NeuFit Neuromuscular Electrical Stimulation to Improve Chronic Pain, Range of Motion, Sleep Quality and Overall Quality of Life in Participants With Orthopedic Pain

The real-world intervention trial led to positive adaptations that were maintained beyond the duration of the study confirming the long-term efficacy of the Neubie Direct Current therapy

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Biostrap

Aug 11, 2021, 08:13 ET

LOS ANGELES, Aug. 11, 2021 /PRNewswire/ -- A seven-week study conducted by Biostrap Labs finds quantitative improvement in chronic pain, range of motion and physiological biometrics with the use of the Neubie Direct Current neuromuscular electrical stimulation (NMES) therapy.

"After about three weeks, I started noticing remarkable improvement in my lower back pain," said Jeremiah O Olaniyan, Biostrap Labs study participant. "The progress in terms of pain and tightness really stuck through even after the study, and I finally have my mornings back without the pain and struggle I had before."

A brief summary of the Biostrap Labs study investigating the physiological impact of the Neubie Direct Current neuromuscular electrical stimulation therapy.

Approximately 20.4% of adults in the US suffer from chronic pain, according to the Centers for Disease Control and Prevention (CDC), with 7.4% reporting high impact chronic pain which is associated with decreased quality of life, opioid dependence and poor mental health.

Additionally, clinical evidence suggests that chronic pain also impacts sleep, causing multiple nightly awakenings, lack of restorative deep sleep and overall poor sleep quality. Would improvements in chronic pain then lead to positive adaptations in all of these aspects of health and wellness?

Based on clinical evidence for maintaining or increasing range of motion, increasing blood circulation, neuromuscular re-education and the management or relief of chronic pain, NMES is already being utilized in various clinical areas including physical therapy and pain management. This study wanted to dive deeper into how it may impact autonomic function, perceived pain and even sleep quality.

"Our initial question was about how the progress made with the NeuFit therapies affect the autonomic nervous system," Ramona von Leden, PhD, director of research and clinical education at NeuFit, said. "If the range of motion and level of perceived pain are improving, is that then, in turn, related to improvements in autonomic function, sleep quality and overall quality of life of patients with orthopedic pain?"

Study results confirmed the hypothesis. Data analysis throughout study phases showed improvements in self-reported pain and range of motion, in addition to decreased resting heart rate (RHR), increased heart rate variability (HRV) and sleep efficiency.

"Various health metrics of interest were moving in the right direction," Biostrap Chief Science Officer Kevin Longoria said. "We recognized day-to-day improvement in HRV and decrease in nocturnal RHR, which led investigators to believe that the therapy was directly impacting the autonomic nervous system leading to less systemic stress and potentially improving cardiorespiratory efficiency."

Because adaptation from daily stressors primarily occurs during sleep, nocturnal health monitoring throughout the night was essential to further understanding the effect of NMES.

"That's where we saw the Biostrap being an excellent tool to determine if there were any changes in sleep and essential physiological biometrics that provide clinically reliable insight into an individual's autonomic nervous system," von Leden said.

While medications may provide short-term improvement in chronic pain, it may not address the root cause or negatively impact other important aspects of health.

However, seeing ongoing positive adaptation even after the therapy phase was concluded showed that improvement in chronic pain was not dependent on continued use of NMES and that the therapy had lasting benefits.

"The Neubie is a stressor which then triggers a positive physiological adaptation," Longoria explained, adding that by looking at data changes in between sessions, they could get a better insight into how the technology is working on a physiological level. "The data analysis indicated that NMES therapy may help people get more restorative deep sleep and decrease the number of awakenings throughout the night, thus improving overall sleep efficiency."

Study design and results:

Participants were recruited from multiple sites with access to the Neubie technology. Measurements were collected on 17 participants with current orthopedic pain, ages 22-61, using the Biostrap wrist-worn photoplethysmography (PPG) device with in-application prompts for daily survey responses for seven weeks.

Following a two-week baseline, participants underwent a total of eight Neubie sessions over approximately four weeks under the care of a certified Neubie specialist. The treatment session duration was roughly 45 minutes during which electrode pads attached to the Neubie would be placed on targeted areas, and the intensity of current would be increased to a perceived intensity of four to eight out of 10 by the participant (this level of intensity is ideal for providing adequate stimulation while still allowing for full movement through prescribed exercises in session). Participants would then undergo a series of physical therapy exercises as directed by their certified practitioner. The specific exercises used would depend on the targeted area, but they would be used to activate the muscles, increase blood flow, stimulate the nerves and increase movement in the areas experiencing limited range of motion or pain. Participants were followed for one additional week after the conclusion of the therapy to measure the lasting benefits of Neubie Direct Current NMES.

Study results concluded that consistent application of Neubie Direct Current NMES under the care of a certified specialist may provide quantitative improvements in pain, range of motion and physiological biometrics in a population of orthopedic pain without neurological disease.

On average, participants' pain decreased by 21% and range of motion increased by 27% throughout this investigational study. The greatest improvement in pain and range of motion were experienced during the washout period. This improvement during the washout phase post-intervention may be a result of the cumulative nature of the treatment benefits. In addition to the improvements in pain and range of motion, participants showed reductions in their resting heart rate — even without doing cardiovascular exercise — and an improvement in their Biostrap Recovery Score, which is a composite measure of heart rate, heart rate variability, and sleep quality. These improvements demonstrate that there may be additional neurological benefits to sessions with the Neubie device beyond the typical therapeutic goals of addressing pain and range of motion.

Further research is required to establish the statistical significance of these outcomes.

About Biostrap Labs

Biostrap Labs provides a science-based resource to wellness companies that want to validate product claims in a real-world setting, affordably and with the participation of an engaged user base. The research division of Biostrap handles all aspects of managing a validation study including recruitment, data collection, project management, study compliance, data aggregation and analysis as well as reporting. Facilitating data collection through a proprietary and clinically reliable wrist-worn device, Biostrap utilizes machine learning to provide actionable data to improve sleep, recovery and performance. Biostrap is referenced in 14 publications and has 22 clinical studies validating its biometric measurements against gold standard medical diagnostics and use cases in specific medical conditions. Providing an individualized approach to consumers via an app and web dashboard, Biostrap also delivers customizable remote monitoring solutions for medical, clinical and fitness professionals. For more information on Biostrap Labs, visit www.Biostrap.com and follow the company on social media through LinkedIn, Instagram, Facebook and Twitter. The Biostrap app is available for iOS on the Apple App Store and Android on the Google Play Store.

About NeuFit

NeuFit helps people get back to doing what they love, faster. Used by thousands of professionals like physical therapists, chiropractors, athletic trainers, strength coaches and more, plus numerous universities and professional sports teams, NeuFit combines next-generation electrical stimulation and protocols from functional neurology to help people accelerate recovery from injuries and surgeries, restore function lost due to neurological injuries or diseases, and build sustainable and efficient fitness programs. In addition to the large body of clinical evidence, NeuFit is also the subject of multiple ongoing trials evaluating the effectiveness of its technology in areas like post-operative recovery, muscle hypertrophy and functional recovery after stroke. For more information about NeuFit, visit www.Neu.Fit and connect with the company on social media through LinkedIn, Instagram and Facebook.

CONTACT: Klaudia Balogh, [email protected]

SOURCE Biostrap