Clinical trial NCT05972889: Randomized Blinded Evaluation of the Effects of TENS and IFC Compared to a Sham Device and SOC in Patients With Non-Specific CLBP
Official title: Randomized Blinded Evaluation of the Effects of Transcutaneous Electrical Nerve Stimulation and Interferential Current Compared to a Sham Device and Standard of Care in Patients With Non-Specific Chronic Lower Back Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non-Specific Chronic Lower Back Pain
Keywords: TENS
IFC
Lead sponsor: Zynex Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-02
Enrollment: 336
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a prospective, sham-controlled, randomized, single-blinded, multi-center study comparing two different modes of the NexWave device, transcutaneous electrical nerve stimulation (TENS) and interferential current (IFC), with an identical non-functioning NexWave sham device or self-defined standard of care for improvement of pain intensity of non-specific CLBP.


Eligibility criteria: 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

Primary outcomes:
measure: Visual Analogue Scale Pain Rating - NexWave vs. Sham
timeFrame: Four weeks
measure: Visual Analogue Scale Pain Rating - NexWave vs. Control
timeFrame: Four weeks
Secondary outcomes:
measure: Oswestry Disability Index (ODI) - NexWave vs. Sham
timeFrame: Four weeks
measure: Oswestry Disability Index (OD) - NexWave vs. Control
timeFrame: Four weeks
Other outcomes:
Locations:
city: Greenwood Village
country: United States
facility: DBPS Research
state: Colorado
city: Saint Augustine
country: United States
facility: McGreevy NeuroHealth
state: Florida
city: Atlanta
country: United States
facility: Peachtree Orthopedics
state: Georgia
city: Jasper
country: United States
facility: Horizon Clinical Research
state: Georgia
city: Bloomington
country: United States
facility: Applied Pain Institute, LLC
state: Illinois
city: Catonsville
country: United States
facility: CAO Research Foundation
state: Maryland
city: Congers
country: United States
facility: One Oak Medical
state: New York
city: Winston-Salem
country: United States
facility: The Center for Clinical Research, LLC
state: North Carolina
city: Lehi
country: United States
facility: Summit Brain, Spine and Orthopedics
state: Utah
Study officials:
affiliation: The Center for Clinical Research
name: Christopher Gilmore, MD
role: PRINCIPAL_INVESTIGATOR
References: