NCT03973788

Brief Summary

Chronic low back pain (CLBP) is a common reason for which patients are treated with opioids. Because the misuse of prescription opioids has become a serious problem in the Uinted States, finding effective alternative non-pharmaceutical interventions for chronic pain management has become an urgent matter. A phenomenon termed central sensitization (i.e. mal-adaption of the brain) has been hypothesized to be an underlying mechanism for the development of chronic pain, leading to sensory hypersensitivity to extremal stimuli. Therefore, non-invasive brain stimulation, such as repetitive transcranial magnetic stimulation (rTMS) may be an effective intervention to regulate brain excitability, thus reducing chronic pain. However, research has shown inconclusive evidence regarding the rTMS effects on chronic pain reduction, partly due to the heterogeneity of participants in studies to date. Therefore, the primary purpose of this study is to investigate the immediate and short-term effects of rTMS on neurosensory changes (i.e., pain thresholds) in patients with CLBP. The secondary purpuse of the study is to explore the relationship between changes of cortical excitability (TMS parameters) and changes of pain thresholds after the rTMS intervention in patients with CLBP.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 4, 2019

Completed
27 days until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2022

Completed
Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

1.6 years

First QC Date

May 30, 2019

Last Update Submit

January 7, 2026

Conditions

Chronic Low Back Pain (CLBP)

Outcome Measures

Primary Outcomes (1)

  • Pain thresholds

    pressure pain thresholds, cold pain thresholds, and heat pain thresholds, and heat-generated temporal summation using a A Medoc TSA II Neurosensory Analyzer (Medoc ltd., Ramat Yishai, Israel).

    before intervention, immediate after intervention, and one week after intervention

Secondary Outcomes (1)

  • Cortical Excitability

    before intervention and immediate after intervention

Study Arms (1)

Intervention

EXPERIMENTAL

repetitive transcranial magnetic stimulation

Procedure: repetitive transcranial magnetic stimulation (rTMS)

Interventions

repetitive transcranial magnetic stimulation (rTMS)PROCEDURE

A single section of rTMS (2,000 pulses)

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults 18 years of age or older
  • Have LBP for more than 6 months

You may not qualify if:

  • Previous low back surgery, systemic joint disease (e.g. rheumatoid arthritis),
  • Fracture,
  • Infection
  • Tumor or cancer
  • Cauda equina syndrome
  • neurological disorders
  • Neuropathy
  • Raynaud's Disease
  • pregnancy,
  • Inability to maintain the testing and treatment positions (i.e. sitting, supine hook-lying and prone-lying) for 15 minutes at a time.
  • History of significant head trauma,
  • Electrical, magnetic, or mechanical implantation (e.g. cardiac pacemakers or intracerebral vascular clip)
  • Metal implantation in the head and neck areas
  • History of seizures or unexplained loss of consciousness,
  • Immediate family member with epilepsy
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Woman's University

Dallas, Texas, 75235, United States

Location

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Sharon Wang-Price

    Texas Woman's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Pre and post test
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 30, 2019

First Posted

June 4, 2019

Study Start

July 1, 2019

Primary Completion

January 31, 2021

Study Completion

January 13, 2022

Last Updated

January 9, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

The data that support the findings of this study are available on request from the corresponding author, Sharon Wang-Price. The data are not publicly available due to their containing information that could compromise the privacy of research participants.

Locations

US(1)