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

Chronic Pain Clinical Trial

Official title:

Epigenetic Mechanisms and Symptom Clusters Associated With the Resolution of Persistent Pain Following Spinal Cord Stimulation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04960592
• Other study ID #: 260886
• Status: Active, not recruiting
• Start date: February 15, 2021
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Spinal Cord Stimulation
• Syndrome

Intervention

Device:
• Spinal Cord Stimulation
Temporary implantation of a clinical available neurostimulator.

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genes and regulatory regions associated with the resolution of chronic pain	Identification of genes that are associated with the resolution of pain	24 months
Primary	Changes in the day to day functioning	Identification of psychosocial measures (i.e., patient reported outcome measures; pain catastrophizing) and patient reported functioning associated with the resolution of pain	24 months