Shocking back pain relief? new study tests electrical devices
NCT ID NCT05972889
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested two electrical stimulation devices (TENS and interferential current) against a fake device and usual care for people with chronic lower back pain. 334 adults with pain lasting at least 3 months took part. The goal was to see if these devices reduce pain and improve daily function over 4 weeks.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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334 people
The number who actually took part.
- Started
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Nov 2023
- Finished
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Oct 2025
- Lead sponsor
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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
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18 to 70 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: * Ages 18-70, or older if specified by law * Non-specific chronic lower back pain defined as: 1. Having lasted ≥3 months in duration 2. Current Visual Analogue Scale (VAS) pain rating ≥50 out of 100 (or an equivalent of 5 out of 10 on a 10-point scale) 3. No radiating pain below the knee 4. ≥75% back or buttock pain rather than lower extremity pain * Subjects who are willing and capable of providing informed consent * Subjects who are willing and capable of participating in all testing and questionnaire requirements associated with the clinical study Exclusion Criteria: * Any prior home use of the NexWave or any TENS/IFC device * Any history of lumbar spine surgery or spinal fractures * Subjects with a history of rheumatic disease * Subjects with spine disorders, deformities, or severe spinal conditions such as scoliosis and kyphosis, Pott's disease, disc protrusion, or others that can be attributed to specific causes of back pain * Subjects currently prescribed and adherent to opioid therapy * Current implanted cardiac pacemakers, defibrillators, cardiac pumps, spinal stimulators, or other implanted electronic devices * Active psychiatric or uncontrolled mood disorders including subjects on antipsychotic medication, diagnosis of bipolar disorder or schizophrenia, or uncontrolled anxiety or clinical depression * Subjects with a known history of allergic reactions to medical adhesives or any condition that could affect placement of the electrodes * Women of childbearing potential who are pregnant or who are planning to become pregnant during the anticipated study period * Subjects with health conditions that in the Investigator's medical opinion would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or modify outcome data or its interpretation * Subjects who are currently enrolled in another investigational study that would directly interfere with the current study
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Applied Pain Institute, LLC
Bloomington, Illinois, 61701, United States
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DBPS Research
Greenwood Village, Colorado, 80111, United States
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Horizon Clinical Research
Jasper, Georgia, 30143, United States
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McGreevy NeuroHealth
Saint Augustine, Florida, 32095, United States
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One Oak Medical
Congers, New York, 10920, United States
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Peachtree Orthopedics
Atlanta, Georgia, 30327, United States
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Summit Brain, Spine and Orthopedics
Lehi, Utah, 84043, United States
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The Center for Clinical Research, LLC
Winston-Salem, North Carolina, 27103, United States