ThermBack LED is Clinically Proven to Alleviate Low Back Pain, New Study Finds

ThermBack LED is Clinically Proven to Alleviate Low Back Pain, New Study Finds

Written by Therabody scientists: Tim Roberts MSc; Emily E. Munn, PhD, MEd; Rachelle Reed, PhD, MS, ACSM-EP 

Expert contributor: Dr. Kyle Kelleran, Principal Investigator and Professor of Emergency Medicine at the University of Buffalo

A new clinical trial finds that Therabody’s® ThermBack LED reduces lower back pain and the use of over-the-counter pain medications to treat it.  

Lower back pain is one of the most common types of pain experienced and is the leading cause of disability worldwide. It's a pain that 84% of adults are likely to experience in their lifetime. [1] In 2020, it was estimated to impact 619 million people worldwide, and this number is predicted to continue to rise. [2, 3] 

The impact of lower back pain isn’t localized to this area; it impacts everything from experiencing reduced physical and mental capacities, negatively affecting quality of life, well-being, and ability to participate at work and socially. [4] 

“Low back pain is both prevalent and challenging for individuals and their healthcare workers to manage. There is a need for effective interventions to reduce low back pain so people can keep moving, and maintain healthy, active lives,” says Dr. Kyle Kelleran, Principal Investigator and Professor of Emergency Medicine at the University of Buffalo.  

Here’s what the study found. 

How can the therapies included in ThermBack LED help reduce pain?

ThermBack LED is a back wrap that uses four therapies: heat, near and far infrared light, and vibration for fast, effective lower back pain relief. 

Heat therapy: Heat comfortably warms the skin and surface-level muscles, increasing blood flow and circulation. This helps relax tense muscles — lessening pain, [5] reducing soreness and stiffness, improving mobility, and accelerating recovery. [6] A 2021 review found that early treatment of mild, acute back pain with heat helped keep back pain from progressing. [7, 8] 

Infrared light therapy: Near and far-infrared light penetrate even deeper than heat therapy to increase blood flow, reduce inflammation, and promote healing at the cellular level. [9] This can help relax tight muscles and relieve tension. 

Vibration therapy: Vibration therapy is a gentle, rhythmic, massage-like pressure applied to tight muscles that can help relieve pain. A 1984 landmark study found that 59% of people with chronic musculoskeletal and nerve-related pain found pain relief using vibration therapy. Of those who found relief, 72% reported having a more vibrant social life, and 50% reported decreasing pain medication use. [10] 

Each of these therapies alone has been shown to relieve low back pain, and this study aimed to understand the impact and synergistic benefits when combining therapies into a 4-in-1 device.

How was the study conducted?

The 2025 registered clinical trial was conducted at the University of Buffalo's Department of Emergency Medicine. This study had a randomized, counterbalanced crossover design, meaning during the four-week study period, participants used the ThermBack LED device for two weeks, and no device for two weeks, and were randomly assigned to the condition they’d complete first. 

Who participated in the study?

Participants with low back pain were recruited in person through the Buffalo emergency department, an email-based research registry, social media, and word of mouth.  

The participants experienced current acute (short-term) or chronic (longer-term) low back pain: 

  • 64% of the participants experienced low back pain for more than 5 years
  • 51% of the participants experienced pain almost every single day

140 participants completed the study: 

  • 52% were female, 48% male
  • Age range was 20-65, with an average age of 40
  • Average BMI was 30.5 
  • 72% of participants identified as Caucasian

How did the ThermBack LED treatment work?

During the ThermBack LED treatment, participants wore the lower back wrap at least once per day for one full 20-minute session. Based on a compliance survey, participants reported using the device on average, 12 out of the 14 days.  

To mimic real-life treatment, participants could wear the back wrap more often if desired. Some participants used the device multiple times per day, an average of 1.7 times daily.  

During the control phase, participants did not use the device, though some device use was reported. 

What did the study measure?

Participants completed several surveys and function tests, including a: 

  • Self-reported pain experienced and pain intensity
  • Patient-Reported Outcomes Measurement Information System (PROMIS) survey measuring pain interference 
  • Sit-to-stand test measuring physical function 
  • Daily questionnaire on pain interference, pain intensity, and medication use 
  • Self-reported medication use at baseline, mid-point, and after the study 
  • Device feedback survey 

ThermBack LED helped reduce participants low back pain and the intensity of pain experienced

Consistent use of ThermBack LED reduces lower back pain. When using the device consistently, participants had a decreased perception of pain compared to when they were not using the device.

  • 94% of participants reported that the device relieved their lower back pain.
  • 81% of participants reported the Therabody ThermBack LED provides immediate and long-term pain relief.

Pain intensity lowered

The intensity of low back pain experienced can greatly impact one’s quality of life. Participants were asked to rate the intensity of their low back pain at three time points: baseline, after two weeks, and after the study. They rated their pain on a Likert scale that ranges from “had no pain” to “very severe pain.” 

When using the ThermBack LED, participants reported experiencing significantly less pain compared to the group using the control condition.

ThermBack LED is clinically proven to decrease pain's interference with participants’ daily activities

Low back pain has been shown to impact people’s ability to carry out essential activities of daily living, including their ability to independently bathe, eat, and get dressed. [4] 

“Low back pain can be frustrating, expensive, and tough to manage. That’s why we need real solutions that help people move better, recover faster, and stay active and healthy for life,” says Dr. Kelleran.

The PROMIS Pain Interference-Short Form (6a) is a six-question survey designed to assess the extent by which pain influences daily activities. [11]

While using the ThermBack LED device, participants experienced a reduction in pain interference, a reduction that was significant compared to the control period. Participants’ reduction in pain interference scores reached a minimally important difference (between a 2.0-3.5-point change). [12] 

Daily pain interference reduced

Participants also reported the extent to which pain interfered with their daily activities over the last 24 hours. Significant findings showed: 

  • Participants were 60% less likely to report pain interference on days they used ThermBack LED compared to days they did not use the device.
  • Participants were 61% less likely to report pain interference during the overall ThermBack LED use phase relative to the non-device use phase of the study.

ThermBack LED use significantly reduced the extent to which pain interfered with participant's daily lives. Participants reported feeling better day-to-day, with improvements meaningful enough to make a difference in their routines, suggesting the device can help manage everyday pain and improve quality of life.

ThermBack LED is clinically shown to improve physical function

Physical function, a measure of an individual's capacity to carry out physical tasks and maintain mobility, strength, and independence, was also measured objectively through a 5-repetition sit-to-stand test.

Participants’ physical function was assessed by how fast they could complete these reps to gauge their tolerance for movement. At baseline, participants performed the sit-to-stand test in an average of 15 seconds, far slower than the population average of 6.2 seconds.  

When using the ThermBack LED, participants performed the test an average of 1.7 seconds faster than when they didn’t use the device.

While this finding was statistically significant, the average improvement of 1.7 seconds did not meet the threshold of minimal clinical importance (2.3-3.6 seconds). [13] 

That said, even small improvements in physical function can show up as improvements in one’s mobility, quality of life, and activities of daily living. 

With consistent use of ThermBack LED, participants reported taking less pain medication

Participants were asked about their use of over-the-counter or prescription medications to treat their lower back pain using two methods:  

  • A bi-weekly survey administered at baseline, after two weeks, and at the end of the study asked about overall over-the-counter and prescription medication use at the three time points.
  • Daily surveys asked about over-the-counter and prescription medication use over the previous 24 hours. 

Biweekly survey results

Over the 4-week intervention, both groups reported a significant reduction in over-the-counter pain medications during their respective ThermBack LED use study period. There was a 50% reduction in participants who reported over-the-counter pain medication usage following device usage. 

The bi-weekly survey did not indicate a significant reduction in prescription pain medication use corresponding to using the device. Both groups reported reduced prescription pain medication usage during the first two weeks of the study, regardless of whether they started in the ThermBack LED or control group. 

Daily survey results

The 24-hour recall surveys showed that participants reportedly took less over-the-counter and prescription pain medications when using ThermBack LED. 

When using the ThermBack LED, participants were 60% less likely to use over-the-counter pain medication and 66% less likely to use prescription pain medication compared to when they did not use the device. 

Medications can be accompanied by side effects and hefty price tags, making pain management a challenge for many people. ThermBack LED offers a drug-free alternative to pain relief.

Participants reported that ThermBack LED is easy to use and works on pain

Oftentimes, the best solutions are ones that are simple and easy to use, driving consistency. That’s why participants were asked about the efficacy and ease of use of the ThermBack LED device.

  • 98% of participants agreed or strongly agreed that the ThermBack LED was easy to use.
  • 92% of participants agreed or strongly agreed that using the ThermBack LED has improved their ability to manage lower back pain.  
  • 77% of participants agreed or strongly agreed that the ThermBack LED is a medication-free tool to help reduce their lower back pain.  
  • 74% of participants agreed or strongly agreed that their mobility improved after using the Therabody ThermBack LED. 

Because low back pain is often chronic and persistent, participants were asked to estimate the amount of time ThermBack LED helped relieve their lower back pain.

  • 78% of participants reported that the device helped improve their symptoms more than half of the time.
  • 46% of participants reported that the device helped improve their symptoms 76% of the time 
  • 31% of participants reported that the device helped improve their symptoms 51-75% of the time

How does this study influence what we know about low back pain?

“This study gives us great insight into how people with low back pain can use products like the ThermBack LED to properly self-manage their low back pain. Using a product like this may help support them to stay active and use less medication. Pain is part of life, but we saw a significant reduction in how much pain impacted their lives when using the ThermBack LED, allowing them to live their life more wholly,” says Dr. Kelleran on what this study contributes to what we know about treating low back pain.

Looking to the future, Dr. Kelleran wants to explore how pairing ThermBack LED with a structured exercise program can improve pain and physical function. 

“Low back pain may respond best to maintaining movement via physical activity and exercise. Developing and testing a plan that includes the ThermBack LED to help manage pain sensation, exercise while pain is managed, and knowledge of the condition could create a cost-effective way to help self-manage low back pain,” concludes Dr. Kelleran.  

Key takeaways

  • A clinical study found that when participants used the ThermBack LED, they experienced less back pain and had lower-intensity pain
  •  When using the device, participants used fewer over-the-counter and prescription medications according to daily recall surveys 
  • Participants reported reductions in the extent to which pain interfered with their daily activities, and they had better physical function on days they used the device  
  • Participants reported that ThermBack LED is easy to use and effectively offered pain relief with consistent use 

Disclaimer: Clinical trial results (NCT06749912 STUDY00008828) with State University of New York at Buffalo. Therabody, Inc. sponsored the trial, but execution, data analysis, and reporting of results were independent of the funding source. 

 

References

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