Evidence map›Paper›PMID 41057672›Full record

ArticlePain and therapy2025

Reducing Pain and Improving Mobility Using Haptic Patch Technology: Results of the RESTORE Study.

Janet Fason, Peter Hurwitz, Jeffrey Gudin

3 registry-linked trialsAbstract read
In one paragraph

Article in Pain and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06505005 nacompletednot on this map

RESTORE (Relieving Pain and Improving Sleep: Evaluating Topical Pain Relief and Sleep Patches to Optimize Effectiveness)

TypeinterventionalSponsorSuperPatch Limited LLCRan2024 to 2026Enrolled150ConditionsPain, Back, Pain, Acute, Sleep Disorder, Sleep Disorders, Circadian RhythmArmsDrug- free, non-invasive patch (FREEDOM or REM Patch) with haptic vibrotactile trigger technology (VTT) Other Names:, Sham Patch without haptic vibrotactile trigger technology (VTT)
NCT07781384 naenrolling by invitationnot on this map

The OPTIMA Study ("Observing Performance of Haptic Vibrotactile Trigger Technology by Measuring Changes in Resting Metabolic Rate: Assessment and Analysis")

TypeinterventionalSponsorSuperPatch Limited LLCRan2023 to 2026Enrolled150ConditionsResting Metabolic Rate, Energy Metabolism, Haptic Technology, Vibrotactile StimulationArmsIGNITE Patch (Active), Inactive patch
NCT07781397 naenrolling by invitationnot on this map

Prevention and Reduction of Falls: Testing and Evaluating Cutting Edge Haptic Technology (PROTECT)

TypeinterventionalSponsorSuperPatch Limited LLCRan2025 to 2026Enrolled150ConditionsFall Risk, Fall Risk, Fall Prevention, Accidental Falls, Accidental Falls/Prevention & ControlArmsLIBERTY Patch, Sham Patch
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Janet FasonStein Medical Group, Tyrone, GA, USA.
Peter HurwitzClarity Science LLC, 750 Boston Neck Road, Suite 11, Narragansett, RI, 02882, USA. peterh@claritysciences.org.ORCID http://orcid.org/0000-0002-6412-768X
Jeffrey GudinDepartment of Anesthesiology, Perioperative Medicine and Pain Management, University of Miami, Miller School of Medicine, Miami, FL, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAcute and chronic pain affects patients' overall health status and well-being, and the assessment and treatment of these patients can be challenging. Unfortunately, many patients fail to respond to the available multimodal treatment options, with some even failing advanced interventions including surgery. Therefore, alternative approaches to pain treatment represent an unmet medical need. Haptic vibrotactile trigger technology (VTT) is designed to target nociceptive pathways and is theorized to disrupt the neuromatrix of pain. The aim of this study was to evaluate the analgesic effects of a wearable VTT haptic patch in adults diagnosed with mild-to-moderate acute or chronic pain.

methodsThis was a prospective, randomized, controlled, double-blind study. A total of 118 research participants (58 male, 60 female) met the inclusion criteria and were enrolled in the study. Participants were randomly assigned to either a treatment group receiving the active patch (N = 64) or a control group which used a similar-appearing vehicle/placebo patch (N = 54). Assessments were performed at baseline (day 0), day 7, and day 14. Reduction in pain severity and interference was assessed using the validated Brief Pain Inventory (BPI), and range of motion/flexibility assessment was performed using the Schober (only for low back pain), goniometer, and bubble inclinometer tests. Data for the active patch user group and the control group were aggregated and compared over the 14-day time frame of the study.

resultsThe active patch user group had significantly greater improvement in pain severity and reduction in pain interference; in addition, the active patch group showed greater objective improvement in range of motion (ROM)/flexibility than the control group at day 7 and day 14.

conclusionThese findings suggest that this non-pharmacological, noninvasive, topical VTT haptic patch (FREEDOM Super Patch with VTT) can reduce pain severity and increase ROM/flexibility. Considering the multitude of serious adverse effects associated with standard pharmacological pain treatments, clinicians should consider this readily available, over-the-counter VTT patch as a potential first-line or adjunct therapy to treat pain.

trial registrationClinicalTrials.gov identifier, NCT06505005.

Indexed as

FREEDOM PatchHaptic technologyMusculoskeletal painPain managementVibrotactile trigger technology

Identifiers

PMID41057672
PMCPMC12634940

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.