COMPLETED

Randomized Blinded Evaluation of the Effects of TENS and IFC Compared to a Sham Device and SOC in Patients With Non-Specific CLBP

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Conditions

Non-Specific Chronic Lower Back PainTENSIFC

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-11-02
Study Completion:2025-10-21
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05972889

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ages 18-70, or older if specified by law
  2. * Non-specific chronic lower back pain defined as:
  3. 1. Having lasted ≥3 months in duration
  4. 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)
  5. 3. No radiating pain below the knee
  6. 4. ≥75% back or buttock pain rather than lower extremity pain
  7. * Subjects who are willing and capable of providing informed consent
  8. * Subjects who are willing and capable of participating in all testing and questionnaire requirements associated with the clinical study
  1. * Any prior home use of the NexWave or any TENS/IFC device
  2. * Any history of lumbar spine surgery or spinal fractures
  3. * Subjects with a history of rheumatic disease
  4. * 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
  5. * Subjects currently prescribed and adherent to opioid therapy
  6. * Current implanted cardiac pacemakers, defibrillators, cardiac pumps, spinal stimulators, or other implanted electronic devices
  7. * Active psychiatric or uncontrolled mood disorders including subjects on antipsychotic medication, diagnosis of bipolar disorder or schizophrenia, or uncontrolled anxiety or clinical depression
  8. * Subjects with a known history of allergic reactions to medical adhesives or any condition that could affect placement of the electrodes
  9. * Women of childbearing potential who are pregnant or who are planning to become pregnant during the anticipated study period
  10. * 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
  11. * Subjects who are currently enrolled in another investigational study that would directly interfere with the current study

Contacts and Locations

Principal Investigator

Christopher Gilmore, MD
PRINCIPAL_INVESTIGATOR
The Center for Clinical Research

Study Locations (Sites)

DBPS Research
Greenwood Village, Colorado, 80111
United States
McGreevy NeuroHealth
Saint Augustine, Florida, 32095
United States
Peachtree Orthopedics
Atlanta, Georgia, 30327
United States
Horizon Clinical Research
Jasper, Georgia, 30143
United States
Applied Pain Institute, LLC
Bloomington, Illinois, 61701
United States
One Oak Medical
Congers, New York, 10920
United States
The Center for Clinical Research, LLC
Winston-Salem, North Carolina, 27103
United States
Summit Brain, Spine and Orthopedics
Lehi, Utah, 84043
United States

Collaborators and Investigators

Sponsor: Zynex Medical, Inc.

  • Christopher Gilmore, MD, PRINCIPAL_INVESTIGATOR, The Center for Clinical Research

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-02
Study Completion Date2025-10-21

Study Record Updates

Study Start Date2023-11-02
Study Completion Date2025-10-21

Terms related to this study

Keywords Provided by Researchers

  • TENS
  • IFC

Additional Relevant MeSH Terms

  • Non-Specific Chronic Lower Back Pain