Brief Summary

Doctors sometimes treat chronic pain with devices that send mild electrical currents into the spinal cord. This type of treatment is referred to as neurostimulation. A common form of neurostimulation therapy is spinal cord stimulation (SCS). In this study, how SCS affects pain processing and relieves pain will be studied. Multiple forms of SCS will be examined in chronic pain patients who are receiving SCS from their own doctors as part of their standard of care. During the study, participants will be asked to complete a variety of evaluations at certain time points.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable chronic-pain

Timeline

Completed

Started Sep 2021

Typical duration for not_applicable chronic-pain

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.8 years study duration

First Submitted

Initial submission to the registry

January 27, 2021

Completed

5 days until next milestone

First Posted

Study publicly available on registry

February 1, 2021

Completed

7 months until next milestone

Study Start

First participant enrolled

September 11, 2021

Completed

2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2024

Completed

1.8 years until next milestone

Results Posted

Study results publicly available

March 27, 2026

Completed

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

2.8 years

First QC Date

January 27, 2021

Results QC Date

June 17, 2025

Last Update Submit

March 4, 2026

Conditions

Chronic Pain Failed Back Surgery Syndrome Complex Regional Pain Syndromes Neuropathic Pain

Keywords

Spinal cord stimulation

Outcome Measures

Primary Outcomes (1)

Spinal Cord Stimulation (SCS)-Induced Changes in Temporal Summation (TS)
TS refers to an increased perception of pain in response to sequential stimuli of equal physical strength. At the end of each treatment period, TS scores were calculated by subtracting the average pain rating of the single-stimulus trials from the average pain rating of the ten-stimuli trials. If the difference is a positive number, the researchers will conclude that there was pain summation, where larger numbers will indicate increased pain summation or TS. If the difference is zero or a negative number, the researchers will conclude that there was no pain summation or TS.
Up to 30 days

Other Outcomes (3)

SCS-induced Changes in Temporal Summation (TS) - 50Hz (Tonic)-SCS to Sham-SCS
Up to 30 days
SCS-induced Changes in Temporal Summation (TS) - 1kHz-SCS to Sham-SCS
Up to 30 days
Spinal Cord Stimulation (SCS)-Induced Changes in Temporal Summation (TS) - Burst-SCS to Sham-SCS
Up to 30 days

Study Arms (6)

Burst / kHz / Sham / Tonic

EXPERIMENTAL

Participants will be randomized to one of six treatment arms. Participants will receive burst, kHz, tonic, and sham spinal cord stimulation (SCS). Each treatment will be applied for a duration of seven days. Participants will be blinded during programming.