New patch uses heat to zap back pain without pills
NCT ID NCT05137041
First seen Jun 26, 2026 ยท Last updated Jun 26, 2026
Summary
This study tested a special patch that gives off infrared heat to treat mild to moderate acute low back pain. 221 adults with back pain for less than a month wore the patch. Researchers measured how many people felt at least 30% less pain after 5 days without needing extra painkillers.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Infrared therapy patch (FIRTECH)
- What this could lead to
- If it works, this could provide a drug-free option for easing acute low back pain at home.
- What could go wrong
- This is a completed phase 3 trial, but results are not yet published. The patch may not reduce pain more than no treatment, and some people may have skin irritation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
221 people
The number who actually took part.
- Started
-
Nov 2021
- Finished
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Nov 2022
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participants suffering from mild to moderate acute low back pain * Low back pain (lumbar back pain) is defined as pain in the back from the level of the lowest rib down to the gluteal fold * Acute episode is defined as acute pain with less than 1 month duration * With intensity less than or equal to 6 on 0-10 Numerical Rating Scale (NRS) Exclusion Criteria: * Participants suffering from any neurological pathology which could be responsible of the pain * Participants suffering from leg pain irradiation * Participants suffering from chronic lumbar pain of any etiology * Participants with chronic arthrosis and neurological symptoms * Participants experiencing recent significant trauma (i.e., injury related to a fall from a height or motor vehicle crash, or from a minor fall or heavy lifting in a participants with osteoporosis or possible osteoporosis) * Participants with major or progressive motor or sensory deficit, new-onset bowel or bladder incontinence or urinary retention, loss of anal sphincter tone, saddle anesthesia, history of cancer metastatic to bone, and suspected spinal infection * Participants clinically diagnosed with anxiety and/or depression * Participants using any medication for their pain within the last 48 hours within enrollment into the study * Participants taking any systemic medication for their pain within the last 24 hours (48 hours for diclofenac or corticosteroids) * Participants currently using recreational or illicit drugs or with a recent history of drug or alcohol abuse or dependence * Participants with any other medical condition that would interfere with efficacy and safety assessments based on investigator's judgment * Participants having received non-pharmaceutical lower back pain treatment (physiotherapy, heat treatment or massage) within 12 hours prior to enrollment * Participants having received spinal injection back pain treatment within 6 months prior to enrollment * Participants having received surgery due to back pain or rehabilitation due to back pain in the last 12 months * Participants with a known sensitivity to paracetamol * Participants with known cutaneous hypersensitivity to plaster * Participants participating in another clinical study within the past 30 days * Participants who are pregnant or breastfeeding; contraception is mandatory * Participants having damaged, non-intact, or scarred skin in or near the point of patch application * Participants having a known skin sensitivity * Participants having impaired blood circulation The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Investigational Site Number :01
Munich, 80809, Germany
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Investigational Site Number :02
Leipzig, 04103, Germany
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Investigational Site Number :03
Weinheim, 69469, Germany
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Investigational Site Number :06
Bad Homburg, 61348, Germany
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Investigational Site Number :4
Chieti, 66100, Italy
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Investigational Site Number :5
Alessandria, 15100, Italy
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Investigational Site Number :7
Taormina, Messina, 98039, Italy
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