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Behavioural Intervention

TENS for Chronic Lower Back Pain (TENS and LBP Trial)

N/A
Recruiting
Led By Richard E Liebano, PhD
Research Sponsored by University of Hartford
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
people who have experienced back pain for at least 3 months
and have reported a minimal pain level of 3 on the 0-10 Pain Numerical Rating Scale (NRS)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 weeks
Awards & highlights

Summary

This trial will use TENS to reduce chronic low back pain by activating descending inhibitory pathways and reducing central excitability. Results of the trial could lead to improved treatments for chronic low back pain.

Who is the study for?
This trial is for adults aged 18-60 who have been experiencing lower back pain for at least three months, with a pain level of at least 3 out of 10. Participants should not have used TENS therapy in the past five years.
What is being tested?
The study tests if Transcutaneous Electrical Nerve Stimulation (TENS) can reduce pain and improve function in people with chronic low back pain by using high-intensity currents on a large area of the trunk to potentially decrease central nervous system excitability.
What are the potential side effects?
TENS is generally considered safe and may cause mild skin irritation under the electrodes or discomfort from the electrical current. Serious side effects are rare when TENS is used properly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had back pain for at least 3 months.
Select...
My pain level is at least a 3 out of 10.
Select...
I am between 18 and 60 years old.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pain With Movement
Pain at Rest
Secondary study objectives
Conditioned pain modulation
Heat Pain Threshold (HPT)
Pressure Pain Threshold (PPT)
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Active TENSExperimental Treatment1 Intervention
Active TENS: 100 Hz, 200 μs at maximal tolerable intensity
Group II: No TENSActive Control1 Intervention
Participants will wear a TENS unit that will be turned off to blind the outcome assessor
Group III: Placebo TENSPlacebo Group1 Intervention
Placebo TENS: 100 Hz, 200 μs on for 45 seconds and then ramps off.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TENS
2011
Completed Phase 2
~2040

Find a Location

Who is running the clinical trial?

University of HartfordLead Sponsor
13 Previous Clinical Trials
559 Total Patients Enrolled
Richard E Liebano, PhDPrincipal InvestigatorUniversity of Hartford
4 Previous Clinical Trials
320 Total Patients Enrolled
~19 spots leftby Sep 2025
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