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

NCT04960592 | Completed

• 1 other identifier: 260886
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Stimulation; Chronic Pain

Keywords

SCS; Epigenetic; Persistent Pain

Outcome Measures

Primary Outcomes (2)

• Genes and regulatory regions associated with the resolution of chronic pain

  Identification of genes that are associated with the resolution of pain

  24 months

• 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

Study Arms (2)

SCS Responders

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

Device: Spinal Cord Stimulation

SCS Non Responders

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

Device: Spinal Cord Stimulation

Interventions

Spinal Cord Stimulation DEVICE

Temporary implantation of a clinical available neurostimulator.

SCS Non Responders; SCS Responders

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to the UAMS Interventional Pain Management Clinic and Neurosurgery Clinic indicated for a trial neuromodulator device placement. Potentially eligible patients will be identified by health care providers during routine clinic visits. Target enrollment is 100 participants for this study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood samples will be drawn at Baseline visit, 90 day post baseline visit, and approximately 1 year post procedure follow up visit.

MeSH Terms

Conditions

Chronic Pain

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Kimberly Stephens, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: July 14, 2021
• Study Start: February 15, 2021
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: September 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)