Spinal Cord Stimulation Research Study

Completed

• Conditions: Chronic Low Back and Leg Pain

• Registration Number: NCT00768872
• Lead Sponsor: MedtronicNeuro

Brief Summary

The purpose of this study is to characterize a patient's activity levels before and after spinal cord stimulation therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-07
• Study First Submitted QC: 2008-10-07
• Study First Posted: 2008-10-08
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-13
• Last Update Posted: 2016-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• 18 years of age or older
• Candidate for SCS device trial
• Subject is ambulatory
• Diagnosed with low back pain or low back pain plus leg pain for at least 6 months
• Undergoing treatment for low back pain or low back pain plus leg pain
• Does not have or has not had a previous SCS implant
• Willing and able to complete protocol requirements
• Willing and able to sign the study-specific Informed Consent form
• Male or non-pregnant female

Exclusion Criteria

• Have plans to enroll in another clinical study during their participation in this study, or are currently enrolled in a clinical study that could interfere in participation in the trial or affect the scientific soundness of this study
• Cancer or any other malignant disease
• Present or past diagnosis of schizophrenia or of delusional, psychotic, or dissociative disorder
• A pain-related surgery in the previous 12 weeks of enrollment, the intent to undergo surgery during the period of the study
• Non-English speaking or an inability to complete questionnaires accurately

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Physical Activity (total centi-Gs per 5.125 seconds)	4, 12, 24 weeks post implant
Change from Baseline in Posture Parameters (minutes per 24 hours)	4, 12, 24 weeks post implant

Trial Locations

Locations (3)

Napa Pain Institute; 🇺🇸 Napa, California, United States

Medical Advanced Pain Specialists (MAPS); 🇺🇸 Edina, Minnesota, United States

Brigham and Women's Hospital; 🇺🇸 Chestnut Hill, Massachusetts, United States