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Completed

NCT Number: NCT00768872

Spinal Cord Stimulation Research Study

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

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Key information

Conditions

Chronic Low Back and Leg Pain Behavior Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Napa Pain Institute, Napa, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change from Baseline in Physical Activity (total centi-Gs per 5.125 seconds)

    Time frame: 4, 12, 24 weeks post implant

  2. Change from Baseline in Posture Parameters (minutes per 24 hours)

    Time frame: 4, 12, 24 weeks post implant

Sponsors and collaborators

Lead sponsor

MedtronicNeuro

Industry

Registry information

Official study title

Neuro Ambulatory Data Recorder (ADR) Spinal Cord Stimulation (SCS) Study

Acronym: ADR-SCS

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Oct 8, 2008
Registry last updated
Oct 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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