Skip to main content
NCBI home page
Frontiers in Neuroergonomics logoLink to Frontiers in Neuroergonomics
. 2026 Jan 9;6:1674928. doi: 10.3389/fnrgo.2025.1674928

Automated thermo-mechanical therapy for immediate relief in chronic non-specific lower back pain: a randomized controlled trial

Kyle Donnery 1,*, Giuseppina Pilloni 2, Mohamad FallahRad 1, Kiwon Lee 3, Byungyun Han 3, Soonhi Park 3, Jihye Kim 3, Leigh Charvet 2, Marom Bikson 1
PMCID: PMC12827622  PMID: 41585325

Abstract

Objective

Chronic non-specific lower back pain (cNSLBP) is a prevalent and disabling condition, imposing a substantial socioeconomic burden due to high healthcare costs and productivity losses, with limited accessible and effective long-term treatment options. Automated Thermo-mechanical Therapy (ATT) is a promising, non-drug intervention that leverages innovative technical advances to provide multimodal pain relief, offering accessibility and low-cost delivery. This study tested ATT for immediate pain relief in individuals with cNSLBP in a single-session, double-blind, randomized controlled trial.

Methods

Forty participants with cNSLBP were assigned to receive either active ATT (n = 20) or control ATT (n = 20) in a 40-min session with urn randomization. The active device applied heated cylindrical rollers along the spine, using far-infrared heat and mechanical tissue stimulation tailored to spinal alignment. In the control condition, the device used minimal mechanical therapy intensity without heat, targeting only the cervical area to avoid lower back therapeutic effects. Pre- and post-intervention assessments measured changes in pain intensity (primary outcome) via a 100-mm Visual Analog Scale for Pain (VAS-P100), alongside secondary outcomes assessing pain characteristics, anxiety, and functional mobility.

Results

The active ATT group showed a significant reduction in pain on the VAS-P100, with an average decrease of 46.8%, compared to 17.0% in the control group. Participants in the active group also reported significantly greater subjective pain relief (p = 7.88e−05). Secondary outcomes demonstrated significant improvements in lumbar flexibility (Modified-Modified Schober Test, MMST) for the active ATT group compared to the control group (p = 0.0031). No adverse events were reported, and all participants tolerated the intervention well.

Conclusions

A single session of ATT provides immediate, significant pain relief in individuals with cNSLBP, supporting its potential as a safe, non-invasive option for managing chronic back pain. Future studies should examine the long-term benefits of repeated ATT sessions and explore mechanistic insights into thermo-mechanical stimulation's effects on pain and function.

Clinical Trial Registration

ClinicalTrials.gov, identifier: NCT06769321.

Keywords: ATT, cNSLBP, pain, randomized controlled trial (RCT), thermo-mechanical therapy

1. Introduction

Chronic non-specific lower back pain (cNSLBP) is persistent pain localized from the costal margin to the inferior gluteal fold that lasts for 12 weeks or longer and lacks a specific identifiable pathology (Maher et al., 2017). CNSLBP affects approximately 4–20% of the global population and is especially prevalent among adults aged 30–60 (Maher et al., 2017; Buchbinder et al., 2018) years. This often debilitating condition imposes a significant socioeconomic burden, impacting individuals during their peak working years. As a leading cause of disability worldwide, cNSLBP affects millions and contributes to substantial healthcare costs and productivity losses. cNSLBP has been challenging to treat with medical interventions alone because of the complex interaction of biological, psychological, and social factors that influence its onset and persistence.

Pharmacological treatments for cNSLBP, including NSAIDs, opioids, and antidepressants, demonstrate mixed efficacy in short-term pain reduction. However, their long-term effectiveness is limited or complicated by potential risks such as dependency and adverse side effects, underscoring the need for a multimodal approach that incorporates non-pharmacological therapies (Thompson et al., 2020).

Non-pharmacological interventions, such as exercise, psychological therapies, acupuncture, and manual therapies, show consistent benefits in improving pain and function, particularly over the long term. These approaches are generally safer and may offer more sustainable outcomes compared to pharmacological treatments, including for cNSLBP management (Jiang et al., 2022; Deyo et al., 2015; Tetsunaga et al., 2018). However, the effectiveness of these approaches depends on accessibility (particularly in underserved areas), costs (insurance coverage), patient adherence, and quality and consistency of manual intervention delivery. There is a need for a convenient and accessible treatment alternative that requires minimal active effort from participants and produces reliable acute relief for patients.

Automated Thermo-mechanical Therapy (ATT) fills this need as a neuroergonomic intervention that uses an automated device combines mechanical pressure and heat to target musculoskeletal pain and stiffness. This approach can improve the range of motion and functional mobility, making it particularly useful for cNSLBP and related conditions. ATT is delivered through freestanding devices that allow for tailored, consistent treatment sessions with minimal therapist involvement, it achieves this through scans powered by adaptive sensors (Buselli et al., 2011). The automation in these human-centric devices ensure uniform application of heat and mechanical pressure, optimizing therapeutic outcomes by maintaining consistent quality across sessions while reducing the need for continuous manual adjustments by a therapist. Advanced ATT is delivered by a device that includes multi-axis traction and far-infrared thermal projectors (Kim et al., 2022). In this manner, the delivery of the therapy can be both individualized to a patient's unique anatomy and delivered in consistent automated doses.

The mechanism of ATT's therapeutic benefits include enhanced blood circulation, muscle relaxation, and reduced pain through the combined effects of heat and mechanical stimulation. Heat therapy has long been recognized for its analgesic effects, particularly in relation to musculoskeletal pain (Chen et al., 2015; Nadler, 2015). The application of heat to the skin has been shown to promote vasodilation and increase blood flow. This provides increased oxygen and nutrients to the affected tissues (Rabkin, 1987; Hardy and Woodall, 1998). It has also been shown to increase local rates of metabolism and removal of metabolic waste products (Nadler, 2015), as well as increase the elasticity of muscle tissue potentially increasing muscle flexibility and relaxation, reducing tension and stiffness, contributing to pain relief, and improving mobility (Hardy and Woodall, 1998). Heat therapy also activates thermoreceptors, in particular, transient receptor potential vanilloid 1 (TRPV1) receptor, which, in the context of lower back pain and gate control theory, activates signals that block the processing of pain signals in the lumbar dorsal fascia and spinal cord (Freiwald et al., 2021; Green, 2004).

Chronic non-specific lower back pain (cNSLBP) encompasses a wide range of etiologies, with mechanical factors including muscle strain, nerve compression, intervertebral disc herniation, and degenerative changes (Emorinken et al., 2023). Individuals with musculoskeletal disorders often exhibit increased tension in the musculature surrounding the affected area, and such muscle spasms may contribute to secondary lumbar pain (Hirayama et al., 2006). To address these symptoms, various physical therapeutic modalities—such as thermotherapy, massage, manipulation, pharmacologic interventions, injections, and biofeedback—have been employed (Roland, 1986). Among these, physical therapy and rehabilitative approaches are recognized as effective non-pharmacological strategies for reducing pain and muscle tension while promoting spinal functional recovery. These modalities are particularly beneficial for elderly patients and individuals with chronic conditions for whom pharmacologic treatment options may be limited (Karateev et al., 2022). The Automatic Thermal Massager (ATT) developed by Ceragem is designed based on these principles of physical therapy and is anticipated to facilitate the relaxation of paraspinal muscle stiffness and tension, thereby contributing to the alleviation of muscle-related pain associated with LBP and supporting spinal functional restoration (Emorinken et al., 2023).

Mechanical stimulation involves the application of controlled and rhythmic pressure strokes to the body, mimicking the effects of manual massage therapy. ATT typically uses spinal traction and mechanical rollers to apply this form of therapy. Mechanical stimulation-based therapies are primarily used to manage pain (Kim et al., 2020, 2022; Choi et al., 2020a), promote relaxation/autonomic regulation (Lee et al., 2011), increase blood flow (Lee et al., 2011; Tiidus and Shoemaker, 1995; Sefton et al., 2010), and reduce inflammation (Rodrigues et al., 2020). Spinal traction is used for the treatment of an array of intervertebral disc-related problems, pinched nerves, and lower back pain.

While heat and mechanical stimulation individually show promise in alleviating musculoskeletal pain, their combined application in a single therapeutic session may provide synergistic effects. Synergistic effects are expected, particularly, both interventions have been associated with increased blood flow. Additionally, biomechanically, heated tissue has been shown to have increased malleability, which allows for mechanical stimulation to have greater deflection of the tissue. Furthermore, by using mechanical stimulation to deflect the tissue and decrease the distance between the target tissue and the thermal actuator, the target tissue receives more thermal energy.

This dual-action approach holds the potential to enhance treatment outcomes for patients with cNSLBP by addressing multiple underlying mechanisms of pain and dysfunction. To address the need for a device capable of providing acute pain relief for cNSPLBP, a single session immediate pain relief model was chosen. Here, we test acute pain relief and functional improvements following a single session of ATT in individuals with cNSLBP.

2. Methods

2.1. Trial design

This randomized controlled trial (RCT) used a single-session, double-blind, parallel-arm design in accordance with CONSORT guidelines (Figure 1). The administration of the ATT intervention was 40 min, and the research visit lasted approximately 2.5 h in total including with pre- and post-intervention assessments. Participants were randomized to either active or control ATT arm by an independent study team member who was not involved in outcome assessment or intervention delivery using urn randomization. This was done using forty folded paper strips put in a sealed obtuse container. Twenty strips had the serial number of the control device and twenty had the serial number of the active device, one strip was pulled for each participant. Devices used in the study were preprogrammed by the manufacturers to deliver the specified active or control intervention. As this was a pilot study, no formal a priori sample size calculation was performed. The sample size of 40 participants was chosen in line with recommendations for pilot studies, which typically include 24–50 participants to estimate feasibility and variability for future trials (Julious, 2005; Sim and Lewis, 2012).

Figure 1.

Flowchart depicting a study's participant allocation. Enrollment: 48 assessed, 8 excluded (7 unmet criteria, 1 other). Randomized: 40 divided into active and control groups, 20 each. All received interventions. No losses or discontinuations. Analysis: all 40 analyzed, none excluded.

Open in a new tab

Flow of participants in a study of the effect of ATT on cNSLBP.

The study received ethical approval from the City College of New York Institutional Review Board (2024-0288). This study was registered at ClinicalTrials.gov (NCT06769321). All eligible participants provided written informed consent before completing any research procedures.

2.2. Participants

Individuals self-reporting cNSLBP were recruited through regional advertisements and community networks of the City University of New York City College campus. Interested participants were first screened by phone. Eligibility criteria included ages 18–65 years and cNSLBP persisting for ≥12 weeks. Additionally, participants needed a conversational level of English to engage in study procedures. Potential participants were excluded if they had contraindications to mechanical manipulation of the back; history of back surgery within the past three years; recent back injury; presence of back implants or active implanted devices; low back pain resulting from other specific conditions (e.g., infection, neoplasm); sensitivity to heat; circulatory insufficiency; heart disease; or being pregnant or breastfeeding. Individuals with a history of substance use disorder or those with a body weight over 298 lbs (135 kg) were also excluded

Potential participants who met the initial screening criteria were next scheduled for a study visit. When participants arrived for the session, informed consent was obtained before any study procedures were carried out. They then completed additional eligibility criteria including currently rating their pain rating to be at least 40 mm on a 100-mm Visual Analogue Scale for Pain (VAS-P100).

2.3. Equipment

The study intervention utilized two MASTER V6 ATT devices (Master series, CGM MB-1701, CERAGEM Co. Ltd., Cheonan, Korea; Figures 2A, B), each programmed for either active or control treatment. The device programmed for active ATT device (Figure 3A) used heated cylindrical rollers that moved along the spine, applying tissue stimulation and emitting far-infrared heat, which penetrated muscle tissue to promote circulation and muscle relaxation. The device's body scanning system mapped each individual's spine using weight and current sensing sensors, adjusting roller positions to align with spinal length and curvature for precision and personalization. The active program includes scan, pre-stroke, main-stroke1, supporting-stroke, main-stroke2 and finish-stroke cycles. The roller temperature was adjustable, with settings ranging from 30 to 65 °C, tailored to each participant's comfort. The mechanical intensity was also adaptable, focusing on the lower back to ensure a targeted therapeutic effect. In contrast, the control device (Figure 3B) used for the control group delivered a minimal mechanical therapy, intensity below level 1, with no heat, and the mechanical therapy was directed primarily to the cervical area, distant from the lower back, to minimize any therapeutic effect (Figure 3B).

Figure 2.

Diagram illustrating the device design and the ergonomics of the device. Part A shows a rendering of a human laying on the device. Parts B and C show close up diagrams of the mechanical actuators, emphasizing the spinal deformation caused by the actuators.

Open in a new tab

Model of mechanisms for delivery of ATT to the spinal column. (A) Model of automated thermo-mechanical therapy device, the thermal projectors and cylindrical rollers are housed in the superior portion of the device, where the vertebral column rests. (B) Model of the internal mechanical components of the device resting beneath the spine and spinal tissue when inactive. (C) Model of the internal mechanical components of the device when activated, depicting deflection of the spine and spinal tissue.

Figure 3.

Diagram comparing the Active and Control device programs, labeled A and B, each next to graphs with waveforms. Diagrams illustrate diferent stages: pre-stroke scan, main-stroke one and two, supporting stroke, and finishing. Spinal vertebrae are shown in both, highlighting various sections in the context of the graphs.

Open in a new tab

ATT protocols for active and control conditions. (A) The program includes scan, pre-stroke, main-stroke1, supporting-stroke, main-stroke2 and finish-stroke cycles. It uses the automatic mode, which measures the length of the spine according to each cycle zone and is set to apply the in-device temperature and level (range: 30–65 °C/Level: 1–9). After the scan, in the pre-stroke phase, breathing through verbal cues is utilized to facilitate relaxation of deep muscles in the lumbar region. During the main-stroke1 and supporting-stroke, gentle massage is applied to the muscles causing lower back pain. In main-stroke2, intensity is increased and speed decreased to concentrate more intensely on the major muscles contributing to lower back pain. The 20-s stay maneuver in main-stroke2 encourages pelvic stabilization for balancing the muscles connected to the pelvis. This thermal massage cycle is repeated twice, totaling 40 min of thermal massage. To enhance the synergistic effect of pain relief during the thermal massage, an external projector is placed on the abdomen at 30–60 °C. (B) The comparator device is a sham device that has the same outer appearance as the investigational device. Throughout the entire massage session, the intensity was set to a low level, below level 1, in areas unrelated to where the major muscles causing lower back pain are located, minimizing the actual massage effect. Additionally, the temperature was turned off to exclude the effect of thermal therapy.

2.4. Procedures

Once enrolled and consented, participants were randomly assigned to receive either an active or control ATT condition. To ensure double blinding, participants were assigned to a In the active ATT group, participants completed a 40-min session involving various therapy phases, with adjustable intensity and heat applied to the lower back (Figure 2A). The thermal settings ranged from 30 to 65 °C, adjusted based on individual preference, while mechanical intensity was modified to ensure participant comfort. In contrast, participants in the control ATT group received a control session with mechanical intensity set below level 1 and no heat applied (Figure 2B). Additionally, the mechanical stimulation primarily targeted the cervical area, distant from the lower back, to prevent any specific therapeutic effects (Figure 2C).

2.5. Automated thermo-mechanical therapy device

The MASTER V6 (Master series, CGM MB-1701, CERAGEM Co. Ltd., Cheonan, Korea) used in this study is a commercially available automated thermo-mechanical therapy device that combines mechanical spinal stimulation with far-infrared (FIR) heat treatment (see Figure 3). It delivers ATT through the Ceracore Engine™, which integrates the proprietary Spine-TECH™ and Thermal-TECH™ technologies. The device delivers the intervention through heated rollers and an automated body scanning system. The cylindrical rollers move along the spine's natural curvature, applying mechanical tissue stimulation to promote circulation and muscle relaxation. The rollers emit far-infrared (FIR) heat, which penetrates muscle tissue to improve local blood flow. The device's body scanning system uses weight and current sensing sensors to map each individual's spine, adjusting the roller positions based on spinal length and curvature for precise, personalized stimulation. The temperature of the rollers can be customized for specific therapeutic needs, ensuring consistent heat delivery.

2.6. Outcome measures

Study outcomes were administered before and immediately after the 40-min active or control intervention. The primary outcome was change in pain intensity, measured using the 100-mm VAS-P (VAS-P100), before and after the intervention. The VAS-P100 is a unidimensional measure of pain intensity, used to record patients' pain progression or compare pain severity between patients. The 100-mm VAS-P is a straight horizontal line of fixed length of 100 mm. The ends are defined as the extreme limits of the parameter to be measured (pain) orientated from the left (best) to the right (worst). The participant marks on the line the point that they feel represents their perception of their current state. The score is determined by measuring in millimeters from the left-hand end of the line to the point that the patient marks (Jensen et al., 2003).

Secondary outcomes focused on assessing disability related to back pain, pain characterization, anxiety, pain relief, and functional mobility. These were measured by:

Self-reported Questionnaires:

  • - Roland-Morris Disability Questionnaire (RMDQ): the Roland-Morris is a 24-item self-report questionnaire about how low-back pain affects functional activities. Total score can range from 0 (no disability) to 24 (severe disability). The RMDQ is scored by adding up the number of items the patient checks. (Administered only at the pre-ATT intervention to characterize how low back pain affects on daily functions; Roland and Morris, 1983).

  • - McGill Pain Questionnaire (MPQ): this questionnaire is used to evaluate a person experiencing significant pain, to monitor the pain over time and to determine the effectiveness of any intervention. The questionnaire evaluates three different domains: (1) What does the pain look like?; (2) How does your pain change with time?; (3) How strong is your pain? (Melzack, 1975).

  • - State-Trait Anxiety Inventory (STAI): this questionnaire is widely used to measure the state and trait components of anxiety (Spielberger, 1983).

  • - 5-point Verbal Rating Scale for Pain Relief (VRS): verbal rating scales about pain relief on a 5-point rating scale: none = 0, slight = 1, moderate = 2, good = 3, complete relief= 4 (Administered only at the post-ATMB intervention; Ferreira-Valente et al., 2011).

Functional Tests:

  • - Modified-Modified Schöber Test (MMST): this is a physical examination used to measure the ability of a patient to flex the lower back. The patient is standing, examiner marks both posterior superior iliac spine (PSIS) and then draws a horizontal line at the center of both marks. A second line is marked 15 cm above the first line. The patient is then instructed to flex forward without bending the knees as if attempting to touch his/her toes, examiner re-measures the distance between the top and bottom line (Tousignant et al., 2005).

2.7. Statistical analysis

Descriptive statistics (mean ± standard deviation) were calculated to determine participants' demographic and clinical characteristics. Baseline characteristics were compared between groups using independent t-tests for continuous variables and chi-squared tests for categorical variables; all model assumptions were checked before analysis.

A mixed-effect model was used for analysis utilizing within-subject factor “Time” (pre-intervention vs. post-intervention) as a fixed effects and between subjects factor “Group” [active (n = 20) vs. control (n = 20)] as a fixed effect, as well as, their interaction (Group x Time). This model was applied for both primary and secondary outcomes, fitted with the “lme4” package in R. Degrees of freedom for the fixed effects were estimated using the Satterthwaite approximation, which provides more accurate significance testing by accounting for variability in smaller samples, thus minimizing the risk of Type I errors. The fit of the models was evaluated using marginal R2 (representing the variance explained by the fixed effects) and conditional R2 (representing the variance explained by both fixed and random effects).

All statistical analyses were performed in R (Rodrigues et al., 2020). The significance level was set at 0.05, and 95% confidence intervals were calculated for each of the fixed effects.

3. Results

3.1. Participant characteristics

A total of n = 40 participants were enrolled in the study, with n = 20 participants randomly assigned to the active ATT arm and n = 20 to the control arm. The mean age of the participants was 32.18 years (SD = 14.52), with no significant differences between active vs. control ATT in gender distribution across groups (53% male vs. female 47%, p = 0.752), pain (MPQ: 54.45 ± 12.54 vs. 50.00 ± 8.84, p = 0.203), general health (GHQ-12: 18.55 ± 2.46 vs. 20.25 ± 3.43, p = 0.081) and disability (RMDQ: 7.35 ± 3.83 vs. 6.35 ± 3.88, p = 0.417; Table 1).

Table 1.

Demographics and clinical features.

Feature Full sample (N = 40) Active ATT (n = 20) Sham ATT (n = 20) P-value
Age (years), mean (SD) 32.18 (14.52) 34.80 (16.03) 29.55 (12.69) 0.258
Sex % male (n) 53% (21) 55.0% (11) 50.0 (10) 0.752
McGill pain, mean (SD) 52.23 (10.94) 54.45 (12.54) 50.00 (8.84) 0.203
GH12, mean (SD) 19.40 (3.07) 18.55 (2.46) 20.25 (3.43) 0.081
Roland Morris, mean (SD) 6.85 (3.84) 7.35 (3.82) 6.35 (3.88) 0.417
Open in a new tab

3.2. Primary outcome: pain reduction

The primary outcome, pain intensity as measured by the 100-mm VAS-P, demonstrated significant reductions in pain levels within both the active and control ATT groups (Figure 4A). The mixed-effects model (Table 2) revealed a significant Group × Time interaction (β = 16.40, p = 7.88 × 10−5), corresponding to a large effect size (Cohen's d = 1.44). This indicates that the active ATT intervention was substantially more effective in reducing pain than the control. On average, VAS-P100 scores decreased by 46.80% in the active condition compared with 17.02% in the control condition (Figure 4B).

Figure 4.

Graphical representation of pain and relief scores comparing ATT and Control groups. (A) Line graph showing VAS pain score reduction from pre to post-treatment. (B) Bar graph depicting percentage change in VAS pain. (C) Violin plots for pain relief scores, ATT showing greater relief. (D) Line graph illustrating MPQ score reduction. (E) Line graph of spine flexion, showing minimal change. Each graph indicates a decrease in pain or an improvement in treatment outcomes for the ATT group compared to the Control group.

Open in a new tab

Differences in outcome measures before and after intervention by groups. (A) Pairwise comparison of means for the pre-intervention vs. post-intervention VAS-P100 score with individual data points overlaid. (B) Mean percentage change in VAS-P100 scores within subjects for ATT and control conditions. (C) Comparison of 5-Point Verbal Rating Scale for Pain Relief scores assessed post-intervention between ATT and control groups. (D) Pairwise comparison of means for the pre-intervention vs. post-intervention MPQ scores with individual data points overlaid. (E) Pairwise comparison of means for the pre-intervention vs. post-intervention MMST scores with individual data points overlaid.

Table 2.

Mixed effects model summary of VAS-P 100.

Fixed effects Estimate (β) Std. error df t-value p-value 95% CI
Intercept 54.750 2.730 58.887 20.054 <2.0e−16*** (49.452, 60.048)
Group −6.550 3.861 58.887 −1.696 0.0951 (−14.043, 0.943)
Time −24.600 2.621 38.000 −9.385 1.93e−11*** (−29.730, −19.470)
Group: time 16.400 3.707 38.000 4.424 7.88e−05*** (9.145, 23.655)
Variance (intercept): 80.36 (95% CI: [5.935, 11.969])
Residual variance: 68.71 (95% CI: [6.587, 10.234])
Model fit: (0.365, 0.707)
Open in a new tab

***p < 0.001.

3.3. Secondary outcomes

Participants in the active ATT on average reported a 22% reduction in pain according to MPQ scores, while the control group reported an average of 9% reduction (Figure 4D). The mixed-effects model revealed a significant effect of Group × Time interaction (β = 7.200, p = 0.0164; Table 3). On the 5-point verbal pain relief scale (Figure 4C), the active ATT group reported significantly higher pain-relief scores (mean = 2.50, SD = 0.89) than the control group (mean = 0.90, SD = 0.79; t(38) = 6.025, p = 5.263 × 10−7). Anxiety levels, as measured by the STAI, were analyzed in two parts, the “state” (STAI-S) and “trait” (STAI-T) measures. STAI-S decreased over time in both groups, with a 12.79% reduction compared to an 9.80% reduction in the control group; however, no significant Group × Time interaction was found (p = 0.4089; Table 3). The STAI-T scores improved by 7.56% in the active ATT group and 4.54 % in the control group, though no significant Group × Time interaction was observed (p = 0.3777). The MMST, assessing lumbar flexibility, showed significant improvement in the active group when compared to the control group. The Group × Time interaction (β = −0.425, p = 0.0031, 95 % CI [−0.69, −0.16]) indicated that the active ATT group achieved a significantly greater degree of lumbar flexion than the control group. Mean MMST values increased from 4.18 ± 1.52 cm pre-intervention to 4.55 ± 1.57 cm post-intervention in the active group, compared with 4.95 ± 1.84 cm to 4.90 ± 1.88 cm in the control group (Figure 4E).

Table 3.

Mixed effects model summary of secondary outcomes.

Fixed effects Estimate (β) Std. error df t-value p-value 95% CI
McGill pain questionnaire
Intercept 54.550 2.744 49.702 13.748 <2.0e−16*** (49.109, 59.791)
Group −4.450 3.881 49.702 −1.147 0.2570 (−12.004, 3.104)
Time −11.750 2.026 38.000 −5.799 1.08e−06*** (−15.716, −7.784)
Group: time 7.200 2.866 38.000 −2.512 0.0164* (1.591, 12.809)
Variance = 109.57 (95% CI: [7.829, 13.384])
Residual variance: 41.06 (95% CI: [5.092, 7.911])
Model fit = (0.119, 0.760)
State-trait anxiety inventory-state
Intercept 34.750 1.989 53.158 17.467 <2.0e−16*** (30.883, 38.617)
Group 1.000 2.813 53.158 0.355 0.72367 (−4.469, 6.469)
Time −5.850 1.651 38.000 −3.543 0.00107** (−9.082, −2.618)
Group: time 1.950 2.335 38.000 0.835 0.4089 (−2.620, 6.520)
Variance = 51.89 (95% CI: [5.216, 9.339])
Residual variance = 27.27 (95% CI: [4.149, 6.447])
Model fit = (0.084, 0.684)
State-trait anxiety inventory-trait
Intercept 37.750 2.484 42.923 15.195 <2.0e−16*** (32.901, 42.599)
Group 3.950 3.513 42.923 1.124 0.26715 (−2.908, 10.808)
Time −3.500 1.228 38.000 −2.850 0.00702** (−5.903, −1.097)
Group: time 1.550 1.737 38.000 0.893 0.3777 (−1.849, 4.949)
Variance = 108.36 (95% CI: [8.114, 13.021])
Residual variance = 15.08 (95% CI: [3.086, 4.794])
Model fit = (0.059, 0.885)
Modified-modified Schöber test
Intercept 4.1750 0.3820 39.1981 10.929 1.83e−13*** (3.428, 4.922)
Group 0.7750 0.5403 39.1981 1.434 0.159369 (−0.282, 1.832)
Time 0.3750 0.0952 38.000 3.939 0.000338*** (0.189, 0.561)
Group: time −0.425 0.1346 38.000 −3.157 0.003119** (−0.688, −0.162)
Variance = 2.828 (95% CI: [1.331, 2.083])
Residual variance = 0.091 (95% CI: [0.239, 0.372])
Model fit = (0.033, 0.970)
Open in a new tab

*p < 0.05, **p < 0.01, ***p < 0.001.

3.4. Tolerability and feasibility

All participants completed the 40-min ATT or control session without reporting any adverse events. In accordance with trial protocol, two participants in the ATT group requested a reduction in heat intensity, which was adjusted accordingly, allowing them to complete the intervention as planned.

4. Discussion

The results of this randomized, double-blind, controlled trial support the efficacy of a single session of thermo-mechanical therapy in significantly reducing pain intensity in individuals with chronic non-specific lower back pain (Maher et al., 2017; Buchbinder et al., 2018). Our analysis revealed that participants in the active group reported clinically significant analgesic effects (Thompson et al., 2020; Jiang et al., 2022). All primary and secondary outcomes related to pain (VAS-P100, MPQ, and VRS) provided data supporting active ATT's efficacy in reducing pain levels (Buselli et al., 2011; Kim et al., 2020). In addition to improvements in pain, participants who received the active treatment had significant improvements in mobility (MMST) compared to the control group (Chen et al., 2015; Nadler, 2015). These findings are consistent with prior literature on the effects of thermal and mechanical stimulation on analgesic cellular mechanisms, musculoskeletal pain, and quality of life (Hardy and Woodall, 1998; Freiwald et al., 2021; Green, 2004). Trend in STAI scores may be accounted for in part by the relaxation that occurs from laying down for 36 min.

Due to the synergistic effects of heat and mechanical stimulation, combined thermo-mechanical therapy by ATT may offer superior pain relief compared to mechanical or thermal therapies in isolation (Kim et al., 2022; Choi et al., 2020a). Although physiological mechanisms of analgesia and therapeutic benefit for both mechanical and thermal therapies are well validated, physiological mechanisms for synergy of pain relief in combined thermal and mechanical therapy remain elusive. However, deforming tissue to decrease the distance between thermal actuators and target tissue significantly increases the dose of thermal energy that reaches the target tissue. In addition, it is well documented that heated tissues are more malleable and, as such, allows mechanical stimulation to have greater deformation of the tissue which could lead to greater analgesic and vasodilatory effects. Further advantages of the ATT system include: (1) a non-drug, minimal-risk intervention (Lee et al., 2011); (2) providing consistent, standardized treatment doses across participants (practitioner-based variability in manual therapies), which in turn (3) supports RCT rigor (Tiidus and Shoemaker, 1995), (4) device deployability, including to professional (e.g., rehabilitation) or home settings; and (5) supporting both responsive and prophylactic uses (Sefton et al., 2010; Rodrigues et al., 2020). Our RCT provides proof-of-concept evidence supporting the efficacy of ATT-delivered thermo-mechanical therapy for pain management, rehabilitation, and regulatory dysfunctions and warrants further investigation before clinical implementation (Crane et al., 2012; Choi et al., 2020b; Krause et al., 2000).

Funding Statement

The author(s) declared that financial support was received for this work and/or its publication. This study was funded in part by Ceragem Clinical.

Edited by: Hasan Ayaz, Drexel University, United States

Reviewed by: Luis Miguel Ferreira, Escola Superior de Enfermagem do Porto, Portugal

Carmen Liliana Gherghel, National University of Physical Education and Sports, Romania

Abbreviations: ATT, automated thermo-mechanical therapy; cNSLBP, chronic non-specific lower back pain; CONSORT, consolidated standards of reporting trials; FIR, far-infrared; GHQ-12, general health questionnaire-12; IRB, institutional review board; MMST, modified-modified Schöber test; MPQ, McGill pain questionnaire; NSAIDs, non-steroidal anti-inflammatory drugs; RCT, randomized controlled trial; RMDQ, Roland-Morris disability questionnaire; STAI, state-trait anxiety inventory; TRPV1, transient receptor potential vanilloid 1; VAS-P100, 100-mm visual analog scale for pain.

Data availability statement

The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.

Ethics statement

The studies involving humans were approved by the City College of New York Institutional Review Board (2024-0288). The studies were conducted in accordance with the local legislation and institutional requirements. The participants provided their written informed consent to participate in this study.

Author contributions

KD: Data curation, Formal analysis, Investigation, Methodology, Resources, Visualization, Writing – original draft, Writing – review & editing. GP: Conceptualization, Data curation, Formal analysis, Investigation, Methodology, Project administration, Supervision, Validation, Visualization, Writing – original draft, Writing – review & editing. MF: Conceptualization, Data curation, Investigation, Methodology, Project administration, Visualization, Writing – original draft, Writing – review & editing. KL: Supervision, Writing – review & editing. BH: Supervision, Writing – review & editing. SP: Supervision, Writing – review & editing. JK: Supervision, Writing – review & editing. LC: Conceptualization, Investigation, Methodology, Supervision, Writing – original draft, Writing – review & editing. MB: Conceptualization, Investigation, Supervision, Writing – review & editing.

Conflict of interest

KL, BH, SP, and JK were employed by Ceragem Clinical Inc.

The remaining author(s) declared that this work was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

The author MB declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision.

Generative AI statement

The author(s) declared that generative AI was not used in the creation of this manuscript.

Any alternative text (alt text) provided alongside figures in this article has been generated by Frontiers with the support of artificial intelligence and reasonable efforts have been made to ensure accuracy, including review by the authors wherever possible. If you identify any issues, please contact us.

Publisher's note

All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.

References

  1. Buchbinder R., van Tulder M., Öberg B., Costa L. M., Woolf A., Schoene M., et al. (2018). Low back pain: a call for action. Lancet. 391, 2384–2388. doi: 10.1016/S0140-6736(18)30488-4 [DOI] [PubMed] [Google Scholar]
  2. Buselli P., Bosoni R., Busè G., Fasoli P., La Scala E., Mazzolari R., et al. (2011). Effectiveness evaluation of an integrated automatic thermomechanic massage system (SMATH® system) in non-specific sub-acute and chronic low back pain—a randomized double-blinded controlled trial, comparing SMATH therapy versus sham therapy: study protocol for a randomized controlled trial. Trials 12:216. doi: 10.1186/1745-6215-12-216 [DOI] [PMC free article] [PubMed] [Google Scholar]
  3. Chen T. Y., Yang Y. C., Sha Y. N., Chou J. R., Liu B. S. (2015). Far-infrared therapy promotes nerve repair following end-to-end neurorrhaphy in rat models of sciatic nerve injury. Evid. Based Complement. Altern. Med. 1–10: 207245. doi: 10.1155/2015/207245 [DOI] [PMC free article] [PubMed] [Google Scholar]
  4. Choi J. H., Kim E. S., Yoon Y. S., Kim K. E., Lee M. H., Jang H. Y. (2020a). Self-management techniques and subsequent changes in pain and function in patients with chronic low back pain. J. Digit. Converg. 18, 547–555. doi: 10.14400/JDC.2020.18.10.547 [DOI] [Google Scholar]
  5. Choi J. H., Lee J. H., Yoon Y. S. (2020b). Effects of thermo-spinal massage treatment in a patient with rheumatism patient with autonomic nervous system dysfunction: a case report. J. Korea. Chem. Soc. 11, 331–340. doi: 10.15207/JKCS.2020.11.8.331 [DOI] [Google Scholar]
  6. Crane J. D., Ogborn D. I., Cupido C., Melov S., Hubbard A., Bourgeois J. M., et al. (2012). Massage therapy attenuates inflammatory signaling after exercise-induced muscle damage. Sci. Transl. Med. 4:119ra13. doi: 10.1126/scitranslmed.3002882 [DOI] [PubMed] [Google Scholar]
  7. Deyo R. A., Von Korff M., Duhrkoop D. (2015). Opioids for low back pain. BMJ 350:g6380. doi: 10.1136/bmj.g6380 [DOI] [PMC free article] [PubMed] [Google Scholar]
  8. Emorinken A., Erameh C., Akpasubi B., Dic-Ijiewere M. O., Ugheoke A. J. (2023). Epidemiology of low back pain: frequency, risk factors, and patterns in South-South Nigeria. Reumatologia 61, 360–367. doi: 10.5114/reum/173377 [DOI] [PMC free article] [PubMed] [Google Scholar]
  9. Ferreira-Valente M. A., Pais-Ribeiro J. L., Jensen M. P. (2011). Validity of four pain intensity rating scales. Pain. 152, 2399–2404. doi: 10.1016/j.pain.2011.07.005 [DOI] [PubMed] [Google Scholar]
  10. Freiwald J., Magni A., Fanlo-Mazas P., Paulino E., Sequeira de Medeiros L., Moretti B., et al. (2021). A role for superficial heat therapy in the management of non-specific, mild-to-moderate low back pain in current clinical practice: a narrative review. Life. 11, 780–780. doi: 10.3390/life11080780 [DOI] [PMC free article] [PubMed] [Google Scholar]
  11. Green B. G. (2004). Temperature perception and nociception. J. Neurobiol. 61, 13–29. doi: 10.1002/neu.20081 [DOI] [PubMed] [Google Scholar]
  12. Hardy M., Woodall W. (1998). Therapeutic effects of heat, cold, and stretch on connective tissue. J. Hand Therapy. 11, 148–156. doi: 10.1016/S0894-1130(98)80013-6 [DOI] [PubMed] [Google Scholar]
  13. Hirayama J., Yamagata M., Ogata S., Shimizu K., Ikeda Y., Takahashi K. (2006). Relationship between low-back pain, muscle spasm and pressure pain thresholds in patients with lumbar disc herniation. Eur. Spine J. 15, 41–47. doi: 10.1007/s00586-004-0813-2 [DOI] [PMC free article] [PubMed] [Google Scholar]
  14. Jensen M. P., Chen C., Brugger A. M. (2003). Interpretation of visual analog scale ratings and change scores: a reanalysis of two clinical trials of postoperative pain. J. Pain. 4, 407–414. doi: 10.1016/S1526-5900(03)00716-8 [DOI] [PubMed] [Google Scholar]
  15. Jiang J., Pan H., Chen H., Song L., Wang Y., Qian B., et al. (2022). Comparative efficacy of pharmacological therapies for low back pain: a Bayesian network analysis. Front. Pharmacol. 13. doi: 10.3389/fphar.2022.811962 [DOI] [PMC free article] [PubMed] [Google Scholar]
  16. Julious S. A. (2005). Sample size of 12 per group rule of thumb for a pilot study. Pharm. Stat. 4, 287–291. doi: 10.1002/pst.185 [DOI] [Google Scholar]
  17. Karateev A., Polishchuk E., Fesyun A., Konchugova T., Filatova E., Amirdzhanova V., et al. (2022). Magnetic therapy in acute and subacute non-specific back pain: results of an open multicenter study. Eur. J. Transl. Myol. 32:10686. doi: 10.4081/ejtm.2022 [DOI] [PMC free article] [PubMed] [Google Scholar]
  18. Kim K. E., Park J. S., Cho I. Y., Yoon Y. S., Park S. K., Nam S. Y. (2020). Use of a spinal thermal massage device for anti-oxidative function and pain alleviation. Front. Public Health. 8. doi: 10.3389/fpubh.2020.00493 [DOI] [PMC free article] [PubMed] [Google Scholar]
  19. Kim K. E., Shin N. R., Park S. H., Nam S.-Y., Yoon Y.-S., Park S.-K., et al. (2022). Modulation of the human immune status by spinal thermal massage: a non-randomized controlled study. Signa Vitae-J. Anesthesiol. Int. Care J. Emergency Med. J. 18, 137–146. doi: 10.22514/sv.2021.144 [DOI] [Google Scholar]
  20. Krause M., Refshauge K. M., Dessen M., Boland R. (2000). Lumbar spine traction: evaluation of effects and recommended application for treatment. Man. Ther. 5, 72–81. doi: 10.1054/math.2000.0235 [DOI] [PubMed] [Google Scholar]
  21. Lee Y. H., Ri N., Kim S. H. (2011). The effects of heat and massage application on autonomic nervous system. Yonsei Med. J. 52, 982–982. doi: 10.3349/ymj.2011.52.6.982 [DOI] [PMC free article] [PubMed] [Google Scholar]
  22. Maher C., Underwood M., Buchbinder R. (2017). Non-specific low back pain. Lancet 389, 736–747. doi: 10.1016/S0140-6736(16)30970-9 [DOI] [PubMed] [Google Scholar]
  23. Melzack R. (1975). The McGill pain questionnaire: major properties and scoring methods. Pain 1, 277–299. doi: 10.1016/0304-3959(75)90044-5 [DOI] [PubMed] [Google Scholar]
  24. Nadler S. F. (2015). The physiologic basis and clinical applications of cryotherapy and thermotherapy for the pain practitioner. Pain Physician 7:395. doi: 10.36076/ppj.2004/7/395 [DOI] [PubMed] [Google Scholar]
  25. Rabkin J. M. (1987). Local heat increases blood flow and oxygen tension in wounds. Arch. Surg. 122, 221–221. doi: 10.1001/archsurg.1987.01400140103014 [DOI] [PubMed] [Google Scholar]
  26. Rodrigues L. M., Rocha C., Ferreira H. T., Silva H. N. (2020). Lower limb massage in humans increases local perfusion and impacts systemic hemodynamics. J. Appl. Physiol. 128, 1217–1226. doi: 10.1152/japplphysiol.00437.2019 [DOI] [PubMed] [Google Scholar]
  27. Roland M., Morris R. (1983). A study of the natural history of back pain. Spine. 8, 141–144. doi: 10.1097/00007632-198303000-00004 [DOI] [PubMed] [Google Scholar]
  28. Roland M. O. (1986). A critical review of the evidence for a pain-spasm-pain cycle in spinal disorders. Clin. Biomech. 1, 102–109. doi: 10.1016/0268-0033(86)90085-9 [DOI] [PubMed] [Google Scholar]
  29. Sefton J. M., Yarar C., Berry J. W., Pascoe D. D. (2010). Therapeutic massage of the neck and shoulders produces changes in peripheral blood flow when assessed with dynamic infrared thermography. J. Altern. Complement. Med. 16, 723–732. doi: 10.1089/acm.2009.0441 [DOI] [PubMed] [Google Scholar]
  30. Sim J., Lewis M. (2012). The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency. J. Clin. Epidemiol. 65, 301–308. doi: 10.1016/j.jclinepi.2011.07.011 [DOI] [PubMed] [Google Scholar]
  31. Spielberger C. D. (1983). State-trait anxiety inventory for adults [PsycTESTS Dataset]. doi: 10.1037/t06496-000 [DOI] [Google Scholar]
  32. Tetsunaga T., Tetsunaga T., Nishida K., Kanzaki H., Misawa H., Takigawa T., et al. (2018). Drug dependence in patients with chronic pain. Medicine 97, e12748–e12748. doi: 10.1097/MD.0000000000012748 [DOI] [PMC free article] [PubMed] [Google Scholar]
  33. Thompson T., Dias S., Poulter D., Weldon S., Marsh L., Rossato C., et al. (2020). Efficacy and acceptability of pharmacological and non-pharmacological interventions for non-specific chronic low back pain: a protocol for a systematic review and network meta-analysis. Syst. Rev. 9:130. doi: 10.1186/s13643-020-01398-3 [DOI] [PMC free article] [PubMed] [Google Scholar]
  34. Tiidus P., Shoemaker J. (1995). Effleurage massage, muscle blood flow and long-term post-exercise strength recovery. Int. J. Sports Med. 16, 478–483. doi: 10.1055/s-2007-973041 [DOI] [PubMed] [Google Scholar]
  35. Tousignant M., Poulin L., Marchand S., Viau A., Place C. (2005). The modified – modified schober test for range of motion assessment of lumbar flexion in patients with low back pain: a study of criterion validity, intra- and inter-rater reliability and minimum metrically detectable change. Disabil. Rehabil. 27, 553–559. doi: 10.1080/09638280400018411 [DOI] [PubMed] [Google Scholar]

Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Data Availability Statement

The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.

Articles from Frontiers in Neuroergonomics are provided here courtesy of Frontiers Media SA

RESOURCES