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Pain Education + tDCS for Chronic Lower Back Pain
N/A
Recruiting
Research Sponsored by High Point University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up completed prior to first intervention session and immediately following final intervention sessions
Awards & highlights
Study Summary
This trial is testing if a cognitive-behavioral intervention combined with transcranial direct current stimulation (tDCS) can reduce pain catastrophizing, kinesiophobia, and hypersensitivity to pressure stimuli in patients with chronic low back pain (CLBP).
Who is the study for?
This trial is for adults aged 18-65 with chronic low back pain lasting at least 3 months, experiencing pain on most days over the past half year, and high levels of pain catastrophizing and fear of movement. Excluded are those with neuropathy, pregnancy, certain medication use, previous back surgery or psychiatric illness requiring meds, inability to sit for long periods, specific diseases like Raynaud's or rheumatoid arthritis, substance abuse issues, neurological disorders or contraindications to tDCS.Check my eligibility
What is being tested?
The study tests if combining Pain Neuroscience Education (PNE) with Transcranial Direct Current Stimulation (tDCS) can reduce exaggerated pain responses and fear of movement in people with chronic lower back pain. It also explores how these treatments might affect brain networks related to cognitive-affective aspects of chronic pain.See study design
What are the potential side effects?
Potential side effects from tDCS may include mild tingling or itching under the electrode during application; headache; fatigue; nausea; and less commonly insomnia. PNE generally does not have physical side effects but could cause emotional discomfort when confronting beliefs about pain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ completed prior to first intervention session and immediately following final intervention sessions
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~completed prior to first intervention session and immediately following final intervention sessions
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain
Change in Pain Catastrophizing Scale
Change in Stroop Color Word Test
+1 moreSecondary outcome measures
Change in Coding Test
Change in Comprehensive Trail Making
Change in Pressure Pain Thresholds
Other outcome measures
Functional MRI
Trial Design
1Treatment groups
Experimental Treatment
Group I: Combined tDCS and PNEExperimental Treatment2 Interventions
This is a single-arm pilot study used to evaluate the treatment effects of combining pain neuroscience education (PNE) and transcranial direct current stimulation (tDCS). All participants will receive the same Intervention, which includes five sessions of tDCS to the left dorsolateral prefrontal cortex (DLPFC) plus PNE over two weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pain Neuroscience Education
2018
N/A
~910
Transcranial Direct Current Stimulation
2014
Completed Phase 3
~1100
Find a Location
Who is running the clinical trial?
High Point UniversityLead Sponsor
13 Previous Clinical Trials
1,335 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have nerve damage.You are taking medicine that can lower the seizure threshold.You have had surgery on your lower back in the past.You can't sit still for at least 30 minutes during testing or treatment.Criterion: You have Raynaud's disease.You have been diagnosed with cancer.You have a neurological disorder.You have a metal implant in your head or neck.You have a history of seizures or passing out without a clear reason.A close family member has epilepsy.You have had ongoing back pain for at least 3 months, and it has caused you pain on most days for the past 6 months.You have been treated for a mental illness with medication.You must be between 18 and 65 years old.You have a pain catastrophizing scale score higher than 30.You have signs of serious issues like broken bones, infections, tumors, or cauda equina syndrome.You are currently misusing alcohol or drugs.You have a disease that affects your joints throughout your body, like rheumatoid arthritis.You are not eligible if you have had a serious head injury in the past.You have an implanted device like a pacemaker or a vascular clip.
Research Study Groups:
This trial has the following groups:- Group 1: Combined tDCS and PNE
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Chronic Lower Back Pain Patient Testimony for trial: Trial Name: NCT05571215 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are elderly individuals being accepted for enrollment in this clinical trial?
"According to the inclusion criteria, potential candidates must fall between 18 and 65 years old."
Answered by AI
Is this research actively recruiting participants at the moment?
"Affirmative. The particulars available on clinicaltrials.gov reveal that this experiment is actively seeking participants, with the first posting appearing in July 1st 2022 and most recent amendments made October 4th of the same year. 40 volunteers are being recruited at a single site."
Answered by AI
What is the current number of participants in this research endeavor?
"Affirmative. According to the clinicaltrials.gov site, this medical study is presently recruiting volunteers. Initially published on July 1st 2022, it was recently updated October 4th and requires 40 participants from one location."
Answered by AI
What eligibility criteria are needed for prospective participants in this trial?
"For this clinical trial, 40 individuals between 18 and 65 years of age who suffer from chronic low back pain (lasting for at least 3 months with symptoms present on half the days in a 6-month period) and demonstrate scores >30 on Pain Catastrophizing Scale are needed."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
California
North Carolina
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
High Point University
How many prior treatments have patients received?
1
3+
Why did patients apply to this trial?
My back pain is getting progressively worse.
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Average response time
- < 2 Days
Most responsive sites:
- High Point University: < 48 hours
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