Enhancing Cortical-hippocampal Functional Connectivity as a Novel Means for Relieving Chronic Low Back Pain
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Pain
- Sponsor
- Northwestern University
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Changes in Pain Scales
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
In this study the investigators aim to examine the effects of Transcranial Magnetic Stimulation (TMS) on hippocampal network connectivity and pain levels in individuals with chronic low back pain.
Investigators
Apkar Apkarian
Director Center for Translational Pain Research, Director Center of Excellence for Chronic Pain and Drug Abuse Research, Professor of Physiology, Anesthesia, PM&R Northwestern University, Feinberg School of Medicine
Northwestern University
Eligibility Criteria
Inclusion Criteria
- •≥ 6 months of back pain on a daily basis;
- •male or female with no racial or ethnic restrictions;
- •18 to 75 years old;
- •average back pain intensity \> 4/10 at study entry;
- •must be able to read, understand, and sign consent form;
- •generally healthy.
Exclusion Criteria
- •back pain with fever, chills, rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures,
- •history of tumor in the back;
- •back surgery within the past 6 months;
- •Chronic neurologic conditions, e.g., Parkinson's
- •involvement in litigation regarding back pain;
- •other severe medical diseases;
- •pregnancy;
- •positive urinary screen for any recreational drugs,
- •opioids use;
- •use of anticoagulants (low dose ASA allowed);
Outcomes
Primary Outcomes
Changes in Pain Scales
Time Frame: Pain is assessed at baseline, end of first intervention and end of the second intervention.
The endpoint will be the severity of pain measured by changes in the Numeric Rating Scale (NRS) scores before and after each stimulation round. The NRS is a pain screening tool that assesses pain severity during assessment using a 0-10 scale, where zero means "no pain" and ten means "the worst pain imaginable." Higher values indicate a worse outcome.
Secondary Outcomes
- Changes in Hippocampal Connectivity(approximately 6 weeks - Baseline and after the end of hippocampal stimulation)