SCS Research Study

Trunk Pain Clinical Trial

Official title:

Spinal Cord Stimulation Research Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03763708
• Other study ID #: MDT18036
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 12, 2018
• Est. completion date: January 2029

Study information

• Verified date: June 2023
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To characterize the effects of stimulation parameters on pain relief and other cohort specific outcomes.

Description:

This post market study will measure the following:

• Numeric Pain Rating Scale

• Satisfaction and Stimulation Assessment

• Stimulation feedback

• Stimulation parameters

• Anatomical locations of active contacts

• Stimulation thresholds

• Location of paresthesia

• Oswestry Disability Index

• European Quality of Life 5-Dimensions

• To characterize non-invasive health monitoring data

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 360
• Est. completion date: January 2029
• Est. primary completion date: January 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

1. 22 years of age or older

2. Implanted with a Medtronic rechargeable neurostimulation system, for a labeled indication, for at least 1 month and expected longevity of neurostimulator is at least 5 months

3. Willing and able to provide signed and dated informed consent

4. Capable of comprehending and consenting in English

5. Willing and able to comply with all study procedures, including diary completion, and visits

6. Able to differentiate between pain associated with the indication for SCS implant and other types of pain

Exclusion Criteria:

1. Implanted with neurostimulation system for an off-label indication

2. Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results

3. If female, pregnant or is of child-bearing potential and unwilling to use a medically acceptable form of birth control during the study

4. Has untreated major psychiatric comorbidity

5. Has a non-rechargeable neurostimulator where the battery longevity is not able to be estimated with the battery longevity calculator

Related Conditions & MeSH terms

• Limb Pain
• Trunk Pain

Intervention

Device:
• Spinal Cord Stimulation
Programming

Locations

Country	Name	City	State
United States	Regional Brain and Spine	Cape Girardeau	Missouri
United States	Goodman Campbell Brain and Spine	Carmel	Indiana
United States	Twin Cities Pain Clinic	Edina	Minnesota
United States	Carolinas Research Institute	Huntersville	North Carolina
United States	Center for Interventional Pain and Spine	Lancaster	Pennsylvania
United States	West Virginia University	Morgantown	West Virginia
United States	Center for Pain and Supportive Care	Phoenix	Arizona
United States	Pain Diagnostics and Interventional Care	Sewickley	Pennsylvania
United States	Drez One	Somerset	Kentucky
United States	Northwest Pain Care	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric pain rating scale	To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded in clinic or once a day on a multi-day diary, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score from the diary prior to the scheduled visit will be used for analysis.	Up to 16 months