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Effects of Repetitive Transcranial Magnetic Stimulation on Pain Thresholds in Patients With Chronic Low Back Pain

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ClinicalTrials.gov Identifier: NCT03973788
Recruitment Status : Recruiting
First Posted : June 4, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Sharon Wang-Price, Texas Woman's University

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.

Condition or disease Intervention/treatment Phase
Low Back Pain Procedure: repetitive transcranial magnetic stimulation (rTMS) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Pre and post test
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immediate and Short-term Effects of Single-session Repetitive Transcranial Magnetic Stimulation on Pain Thresholds In Patients With Chronic Low Back Pain - A Pilot Study
Actual Study Start Date : January 19, 2019
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Intervention
repetitive transcranial magnetic stimulation
Procedure: repetitive transcranial magnetic stimulation (rTMS)
A single section of rTMS (2,000 pulses)




Primary Outcome Measures :
  1. Pain thresholds [ Time Frame: before intervention, immediate after intervention, and one week after intervention ]
    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).


Secondary Outcome Measures :
  1. Cortical Excitability [ Time Frame: before intervention and immediate after intervention ]
    10 supra-threshold motor evoked potentials (MEP) amplitudes recorded from the first interosseous index (FDI) muscle using a transcranial magnetic stimulation machine (Rapid2, Magstim Co., UK)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  • Use of seizure threshold lowering medicine
  • Current abuse of alcohol or drugs
  • History of psychiatric illness requiring medication controls

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03973788


Contacts
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Contact: Sharon Wang-Price 2146897715 swang@twu.edu

Locations
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United States, Texas
Texas Woman's University Recruiting
Dallas, Texas, United States, 75235
Contact: Sharon Wang-Price, PhD    214-689-7715    swang@twu.edu   
Sponsors and Collaborators
Texas Woman's University
Investigators
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Principal Investigator: Sharon Wang-Price Texas Woman's University

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Responsible Party: Sharon Wang-Price, Professor, Texas Woman's University
ClinicalTrials.gov Identifier: NCT03973788     History of Changes
Other Study ID Numbers: 20394
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms