Treatment With Spinal Cord Stimulation: Effect on Sensory Parameters

Chronic Pain Clinical Trial

Official title:

Treatment With Spinal Cord Stimulation: Effect on Sensory Parameters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01261468
• Other study ID #: SCS-24h
• Status: Completed
• Phase: N/A
• First received: December 15, 2010
• Last updated: March 14, 2012
• Start date: April 2011
• Est. completion date: December 2011

Study information

• Verified date: March 2012
• Source: Danish Pain Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Device:
• Active SCS
SCS IPG activated
• Deactivated
SCS IPG deactivated

Locations

Country	Name	City	State
Denmark	Danish Pain Research Center	Aarhus C

Sponsors (1)

Lead Sponsor	Collaborator
Danish Pain Research Center

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Kemler MA, Reulen JP, Barendse GA, van Kleef M, de Vet HC, van den Wildenberg FA. Impact of spinal cord stimulation on sensory characteristics in complex regional pain syndrome type I: a randomized trial. Anesthesiology. 2001 Jul;95(1):72-80. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in sensory parameters		24 hours	No