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Treatment With Spinal Cord Stimulation: Effect on Sensory Parameters

Treatment With Spinal Cord Stimulation: Effect on Sensory Parameters

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01261468
Enrollment
15
Registered
2010-12-16
Start date
2011-04-30
Completion date
2011-12-31
Last updated
2012-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

Keywords

Chronic pain, Electric Stimulation Therapy, Neurologic Examination

Brief summary

The primary purpose is to study the effect of spinal cord stimulation (SCS) on sensory parameters, using quantitative sensory testing (QST). Patients with established SCS treatment will be examined with QST. Subjects will be randomized to have their SCS device turned off or kept active (1:1) for a 12-hour period, then be reexamined using the same QST protocol. After the 2nd examination all patients cross over (ie. inactive devices are activated, active devices are deactivated) and are reexamined after a new 12-hour period. The investigators expect to demonstrate that SCS treatment has a significant effect on sensory parameters associated with pain hypersensitivity but no significant effect on sensory parameters associated with detection of non-painful stimuli.

Interventions

DEVICEActive SCS

SCS IPG activated

DEVICEDeactivated

SCS IPG deactivated

Sponsors

Danish Pain Research Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* minimum age 18 * able to understand participant information and cooperate at the neurological examination * uncomplicated treatment with spinal cord stimulation for at least 3 months * pain in only one extremity * treatment effect in only one extremity

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frame
Change in sensory parameters24 hours

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026