80 Participants Needed

tACS for Chronic Lower Back Pain

JK
Overseen ByJIAN KONG
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called transcranial alternating current stimulation (tACS) to determine its effectiveness in reducing chronic lower back pain. Participants will receive either the real tACS treatment or a sham version to compare effects. Individuals with lower back pain lasting more than six months and experiencing significant daily pain might be suitable candidates.

As an unphased trial, this study provides a unique opportunity to explore a novel treatment option for chronic pain relief.

Will I have to stop taking my current medications?

Yes, you will need to stop taking regular pain medications like opioids, nonopioid analgesics, and certain other drugs, as well as any psychotropic medications, to participate in this trial.

What prior data suggests that tACS is safe for chronic lower back pain?

Studies have shown that transcranial alternating current stimulation (tACS) is generally safe. Research indicates that no serious side effects have been reported with tACS use. Some minor issues, such as skin problems, have been noted, but these are uncommon. So far, patients seem to tolerate tACS well. For those considering joining a trial, this information is reassuring regarding safety.12345

Why are researchers excited about this trial?

Most treatments for chronic lower back pain, like physical therapy, medication, and surgery, focus on symptom relief rather than addressing the underlying cause. tACS, or transcranial alternating current stimulation, is unique because it uses non-invasive electrical currents to potentially modulate brain activity linked to pain perception. Researchers are excited about tACS because it represents a novel approach that could provide relief without the side effects associated with medications or the invasiveness of surgery. By targeting the brain's pain processing pathways, tACS might offer a new way to manage chronic pain more effectively.

What evidence suggests that tACS is effective for chronic lower back pain?

Research suggests that transcranial alternating current stimulation (tACS) might help people with chronic pain by affecting brain activity. Some studies have found that tACS can lessen pain by correcting unusual brain wave patterns. In this trial, participants will receive either real tACS or a sham tACS treatment. Although tACS did not outperform sham treatments in fibromyalgia, research on chronic low back pain indicates it might help manage pain. Overall, early results are promising, but more research is needed to confirm its effectiveness.16789

Are You a Good Fit for This Trial?

This trial is for individuals who have been experiencing chronic lower back pain for more than six months, with a pain intensity of at least 4 out of 10 on the LBP NRS scale. Participants must be able to read English at a 10th-grade level or higher and meet specific MRI/MEG/EEG screening criteria.

Inclusion Criteria

I can read and understand English at a 10th grade level or higher.
My MRI/MEG/EEG results meet the study's requirements.
My back pain scores at least 4 out of 10.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Transcranial Alternating Current Stimulation (tACS) for low back pain

4 weeks
Baseline and end of treatment visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • tACS

Trial Overview

The study is examining the effects of transcranial alternating current stimulation (tACS) on chronic low back pain by comparing real tACS treatment to sham (placebo) tACS to see if there's any improvement in pain levels.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: real tACSExperimental Treatment1 Intervention
Group II: Sham tACSPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials
1,403
Recruited
655,000+

Citations

Effectiveness of transcranial alternating current stimulation ...

In the study on fibromyalgia, it did not show a better pain-reducing effect of tACS compared with sham stimulation. Two studies on LBP showed ...

Study Details | NCT03243084 | Transcranial Alternating ...

The purpose of this study is to test the feasibility of using tACS to treat patients with chronic pain, and to collect pilot efficacy as well as EEG and EKG ...

Effects of TDCS and TENS on chronic low back pain

No superior effects were observed at post-intervention with tDCS + TENS compared to sham tDCS + TENS (P > 0.05), regardless of stimulation site, for pain relief ...

A Systematic Review and Meta-Analysis on the Effect of ...

Conclusions: The tDCS appears to be an effective and safe intervention for reducing pain and enhancing functional outcomes in CLBP patients, ...

Pain control based on oscillatory brain activity using ...

Several studies have reported that tACS on a single brain reduces pain by normalizing abnormal oscillatory brain activity in patients with chronic pain.

Adverse events of tDCS and tACS: A review - PubMed Central

No serious adverse effects have been reported in experiments using either tDCS or tACS. Persistent adverse effects of tDCS are mainly skin problems; for tACS, ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/28827229/

a protocol for a pilot randomised controlled trial

This pilot trial aims to (1) determine the feasibility, safety and perceived patient response to a combined transcranial direct current stimulation (tDCS) and ...

Modulation Effect of tACS on Chronic Low Back Pain

Also called a data safety and monitoring board, or DSMB. ... Modulation Effect of Transcranial Alternating Current Stimulation (tACS) on Chronic Low Back Pain.

Safety of Transcranial Direct Current Stimulation: Evidence ...

This review updates and consolidates evidence on the safety of transcranial Direct Current Stimulation (tDCS).