Epigenetic Mechanisms and Symptom Clusters Associated with Resolution of Pain Following Spinal Cord Stimulation

NCT ID: NCT04960592

Last Updated: 2024-09-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 61 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-15
• Study Completion Date: 2024-07-01

Brief Summary

Spinal cord stimulation (SCS) is indicated for selected patients with chronic pain who have not responded to conventional medical management.

Forty (40) patients indicated for SCS placement and presenting to the University of Arkansas for Medical Sciences (UAMS) Interventional Pain Management Clinic in Little Rock, Arkansas will be recruited for this study. Prior to temporary stimulator placement, patients will complete symptom-related questionnaires and provide a blood sample. Demographic and clinical characteristics will be obtained through medical record review. Patients will complete the same questionnaires and provide a blood sample at each of the routine clinical care follow-up visits.

Detailed Description

Neuromodulation has emerged as a minimally invasive therapy effective for the treatment of refractory neuropathic pain conditions. Epidural placement of electrodes provides long term analgesia through electrical stimulation of the spinal cord which alters expression of genes involved in synaptic signaling in the dorsal horn. Patients who receive SCS represent a unique opportunity to study the physiological mechanisms associated with the resolution of chronic pain.

This is a descriptive, prospective, longitudinal study that will consist of individuals with persistent pain and meet criteria for implantation of a neurostimulation device. One hundred patients indicated for neurostimulation device placement and presenting to the University of Arkansas for Medical Sciences Interventional Pain Management Clinic in Little Rock, Arkansas will be recruited for this study. Patients who meet study inclusion criteria will be recruited to participate prior to stimulator placement procedure. Following an initial consultation and exam by a physician, patients will have necessary imaging and neuropsychological evaluation. Prior to SCS placement procedure, the patient will complete preoperative labs.

At baseline, patients will be asked to complete the demographic questionnaire, and physical functioning questionnaires, and provide a blood sample. Blood samples will be drawn and stored until sample processing is completed. Medical records will be reviewed and abstracted for research-related data elements from electronic medical records. Questionnaire and form responses are collected and recorded for study use.

Study time points for data collection and sample collection are Baseline (Pre-treatment), routine follow-up visit < 60 days after baseline, 3 months, and 1-year post-implant procedure.

Conditions

Spinal Cord Stimulation; Chronic Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

SCS Responders

Patients who receive Spinal Cord Stimulation treatment and experience greater than 50% reduction in pain score following treatment.

Spinal Cord Stimulation

Intervention Type: DEVICE

Temporary implantation of a clinical available neurostimulator.

SCS Non Responders

Patients who receive Spinal Cord Stimulation treatment and do not experience greater than 50% reduction in pain score following treatment.

Spinal Cord Stimulation

Intervention Type: DEVICE

Temporary implantation of a clinical available neurostimulator.

Interventions

Spinal Cord Stimulation

Temporary implantation of a clinical available neurostimulator.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adults (age greater than or equal to18 years) who meet clinical criteria for implantation of a neuromodulation device
• Able to speak, write, and understand English

Exclusion Criteria

• Evidence of monetary gain related to the outcome of the procedure (example worker's compensation, ongoing litigation, pending disability claim)
• Pain greater than 4/10 on pain scale at a bodily site not being treated by the neuromodulation procedure

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kimberly Stephens, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Countries

United States

Other Identifiers

260886

Identifier Type: -

Identifier Source: org_study_id