Spinal Cord Stimulation Research Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2013-03-31

Brief Summary

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

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Detailed Description

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Conditions

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Chronic Low Back and Leg Pain

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No