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Behavioural Intervention

TENS and IFC for Chronic Lower Back Pain

N/A
Recruiting
Led By James M. North, MD
Research Sponsored by Zynex Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Non-specific chronic lower back pain defined as: having lasted ≥3 months in duration, current Visual Analogue Scale (VAS) pain rating ≥50 out of 100 (or an equivalent of 5 out of 10 on a 10-point scale), no radiating pain below the knee, ≥75% back or buttock pain rather than lower extremity pain
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up four weeks
Awards & highlights

Study Summary

This trial tests two medical devices to help people with chronic lower back pain.

Who is the study for?
This trial is for adults aged 18-70 with non-specific chronic lower back pain lasting over 3 months, a pain rating of at least moderate intensity, and most pain located in the back or buttocks. It excludes those with specific spinal conditions, rheumatic diseases, opioid therapy adherence, electronic implants like pacemakers, pregnant women or those planning pregnancy during the study period.Check my eligibility
What is being tested?
The study tests two modes of NexWave device: TENS and IFC against a sham (fake) device and standard care to see which is better for reducing non-specific chronic lower back pain. Participants are randomly assigned to one of these treatments without knowing which one they receive.See study design
What are the potential side effects?
While not specified here, common side effects from devices like NexWave may include skin irritation where it's applied due to adhesives or electrical stimulation discomfort. Serious side effects are rare but could involve worsening pain if improperly used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have chronic lower back pain for over 3 months, with most pain in my back or buttocks, not below the knee.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~four weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and four weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Visual Analogue Scale Pain Rating - NexWave vs. Control
Visual Analogue Scale Pain Rating - NexWave vs. Sham
Secondary outcome measures
Oswestry Disability Index (OD) - NexWave vs. Control
Oswestry Disability Index (ODI) - NexWave vs. Sham

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Device TENSExperimental Treatment1 Intervention
Group II: Device IFCExperimental Treatment1 Intervention
Group III: ControlActive Control1 Intervention
Subjects continue with current standard of care only for 4 weeks with the option to crossover to the NexWave Device group for an additional 4 weeks (up to 8 total weeks).
Group IV: Sham TENSPlacebo Group1 Intervention
Group V: Sham IFCPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Zynex Medical, Inc.Lead Sponsor
1 Previous Clinical Trials
14 Total Patients Enrolled
James M. North, MDPrincipal InvestigatorThe Center for Clinical Research

Media Library

Interferential Current (IFC) (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05972889 — N/A
Chronic Lower Back Pain Research Study Groups: Device IFC, Sham TENS, Sham IFC, Control, Device TENS
Chronic Lower Back Pain Clinical Trial 2023: Interferential Current (IFC) Highlights & Side Effects. Trial Name: NCT05972889 — N/A
Interferential Current (IFC) (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05972889 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to participate in this clinical trial?

"The requirements to be eligible for the study include chronic lower back pain and being between 18-70 years old. Currently, 336 participants are needed to complete this medical trial."

Answered by AI

Is enrollment open to individuals beneath the age of thirty-five in this experiment?

"Participants must meet the age requirements of this trial, which is a minimum of 18 and maximum of 70 years old."

Answered by AI

Are recruitment efforts still ongoing for this medical experiment?

"According to clinicaltrials.gov, recruitment for this medical trial has ceased since July 25th 2023. Despite that, there are still 317 different clinical trials open and actively seeking new participants."

Answered by AI

Who else is applying?

What site did they apply to?
CAO Research Foundation
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Randomized Blinded Evaluation of the Effects of TENS and IFC Compared to a Sham Device and SOC in Patients With Non-Specific CLBP
2023. "Randomized Blinded Evaluation of the Effects of TENS and IFC Compared to a Sham Device and SOC in Patients With Non-Specific CLBP". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05972889.
All > Lower Back Pain
~96 spots leftby Jun 2024
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