Optimal Duration of Spinal Cord Stimulation Trial Procedure: Length and Diagnostic Accuracy

University of Maryland Baltimore (UMB)

Status

Invitation-only

Conditions

Chronic Pain

Treatments

Diagnostic Test: Daily survey

Study type

Observational

Funder types

Other

Identifiers

NCT07016581

HP-00113001

Details and patient eligibility

About

This study aims to find out the optimal duration (in days) needed for a spinal cord stimulator (SCS) trial procedure for treating chronic pain. While shorter trial periods could lower risks like infections or bleeding (especially for patients who need to stop blood thinners), patients also need sufficient time to achieve meaningful pain and function relief, and to report willingness to proceed to permanent implantation. Unfortunately, the optimal duration of an SCS trial procedure is not currently known. We aim to explore this optimal duration across a multi-center study by studying daily surveys completed across the duration of SCS trial procedures.

Full description

Spinal cord stimulation (SCS) is a well-established therapy for chronic pain. However before one can proceed with SCS as a permanent therapy, they must undergo an antecedent SCS trial procedure to assess its effectiveness as a treatment for the patient's pain. The SCS trial procedure involves the percutaneous placement of leads with electrical contacts into the epidural space.

Given the infectious risks associated with an SCS trial, including those associated with significant morbidity and mortality, the typical duration of an SCS trial procedure ranges from 3 to 14 days. Additionally, given the risks for epidural hematoma formation, patients on certain anti-platelet and anti-coagulant medications require medication cessation prior to and across the SCS trial duration. In these scenarios, prolonging the withholding of these medications can place these patients at serious risks for serious embolic and/or vascular events. However, while reducing the duration an SCS trial procedure may help mitigate the risks for serious infectious and embolic and/or vascular events, patients with chronic pain conditions may typically need several days to achieve and report meaningful analgesic and functional responses and willingness to proceed with a permanent SCS implantation procedure. However, the optimal duration required for an SCS trial response has yet to be clearly established.

In this study, we aim to explore the optimal duration of the SCS trial procedure and assess how daily pain levels and patient satisfaction impact the decision to permanently implant a SCS device. The primary objective is to determine the optimal number of days required to accurately predict SCS trial procedure outcomes.

This prospective, multi-center study will enroll a target of 100 patients undergoing an SCS trial procedure (conducted in accordance to standard clinical practices per site). In addition to demographics, Patient-Reported Outcomes Measurement Information System (PROMIS) scores, SCS e-health tool recommendations, and key SCS parameters, patients will complete daily surveys to assess their analgesic and functional benefit across the duration of the SCS trial. Analyses will be performed to determine: 1) the number of days it takes to define final trial outcomes (for positive responders and not-positive responders); 2) if and how PROMIS domains correlate with days to define final trial outcomes; and 3) if and how SCS e-health tool recommendations correlate with days to define final trial outcomes.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age >18 years old, with capacity for study consent
Clinical evidence of a chronic pain condition amenable for treatment with spinal cord stimulation
Chronic pain duration >12 weeks

Exclusion criteria