← Back to Search

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

TENS and LBP Trial 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.Check my eligibility

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.See study design

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.

TENS and LBP Trial 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.

TENS and LBP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pain With Movement

Pain at Rest

Secondary outcome measures

Conditioned pain modulation

Heat Pain Threshold (HPT)

Pressure Pain Threshold (PPT)

+3 more

TENS and LBP 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

0 / 3Eligibility criteria met

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

Frequently Asked Questions

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

Is enrollment still available for this clinical experiment?

"Affirmative. Clinicaltrials.gov states that this clinical trial, initially posted on November 15th 2023, is actively recruiting individuals for study participation. 34 participants are being sought out by the research team at a single site."

Answered by AI

What is the enrollment capacity for this clinical trial?

"Affirmative. According to clinicaltrials.gov, this research study is recruiting patients and has been since November 15th 2023; the post was last updated on November 27th 2023. Currently, 34 participants are needed at a single site for enrollment in the trial."

Answered by AI

Are elderly individuals above a certain age able to partake in this research?

"According to the requirements of this trial, only individuals between 18 and 60 years old can participate. Separately, 9 clinical trials are available for those under 18 whereas 252 studies cater to seniors aged 65 or above."

Answered by AI

To what end is this experiment striving?

"This 3-week medical study aims to assess Pain With Movement. Secondary objectives comprise the Repeated Trunk Flexion test, Pressure Pain Threshold (PPT) measure and Heat Pain Threshold (HPT). The former entails 10 repetitions of flexing from a neutral standing position as rapidly as possible, while PPT is determined with a digital pressure algometer and HPT involves using a handheld thermode for heat pain sensitivity testing."

Answered by AI

Am I suitable to become a participant in this research?

"This clinical trial is recruiting 34 volunteers with chronic lower back pain aged 18 to 60. To be eligible, individuals must have had a minimum of 3 months' duration of the condition and register at least a 3 on the 0-10 Pain Numerical Rating Scale (NRS). Additionally, any applicants who are TENS users must not have used it for 5 years prior to joining this study. Men and women may apply alike."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Transcutaneous Electrical Nerve Stimulation (TENS) and Low Back Pain

Richard Liebano 2023. "Transcutaneous Electrical Nerve Stimulation (TENS) and Low Back Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05812885.

All > Lower Back Pain