Sub-Sensory Intraspinal Neurostimulation Therapy

NCT01976598 | Terminated

• 2 other identifiers: ALG-ANA100120131546
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the optimal stimulation parameters and locations for sub-perception programming in patients with previously implanted spinal cord stimulation systems for the treatment of chronic back and/or leg pain.

Conditions

Back Pain; Back Pain With Radiation; Pain in Leg, Unspecified

Keywords

chronic; back; leg; pain; sub-sensory; stimulation; Neuromodulation; Yearwood

Outcome Measures

Primary Outcomes (1)

• Visual Analog Score (VAS)

  The primary outcome measure is the final visual analog score (VAS) score obtained using a paper pain diary obtained on the last evening of each program.

  32 days

Study Arms (1)

Spinal Cord Stimulation: Sub-Sensory

Patients implanted with a Boston Scientific Spinal Cord Stimulation System for the treatment of chronic back and/or leg pain using Sub-Sensory Stimulation.

Other: Sub-Sensory Stimulation

Interventions

Sub-Sensory Stimulation OTHER

Sub-Sensory Stimulation using Boston Scientific Spinal Cord Stimulation System in patients currently implanted with the system .

Also known as: Sub-Sensory Spinal Cord Stimulatiocn.

Spinal Cord Stimulation: Sub-Sensory

Eligibility Criteria

• Age: 22 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients implanted with a Boston Scientific Spinal Cord Stimulation System for the treatment of chronic back and/or leg pain

You may qualify if:

• Primary pain complaint of persistent or recurrent low back and/or leg pain, with or without leg pain, for at least 180 days prior to Baseline.
• Received a Boston Scientific SCS System with active contacts located between superior endplate of T7 and the inferior endplate of T10 with a minimum of three active contacts within this anatomical area.
• No back surgery within 180 days prior to Baseline.
• Has had stimulator "on" (activated or operational) for at least 36 hours prior to Baseline evaluation.
• Average low back and/or leg pain intensity, during the position/activity which routinely causes worst pain, of 5 or greater on a 0-10 numerical rating scale without neurostimulation.
• If taking prescription opioids for primary chronic pain complaint (low back and/or leg pain), must have been on a stable prescription (same drug(s) and dose(s)) for 30 days prior to Baseline
• Consumed an average total daily morphine equivalent of ≤300 mg during the 30 days prior to Baseline
• Willing and able to comply with all protocol-required procedures and assessments/evaluations (e.g. willing to comply with opioid prescription lock throughout the study, changes to the stimulation parameters, complete twice-daily diary)
• years of age or older when written informed consent is obtained
• Able to independently read and complete all questionnaires and assessments provided in English
• Subject signed a valid, IRB-approved informed consent form (ICF) provided in English

You may not qualify if:

• Any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment, might confound reporting of study outcomes (e.g. pelvic pain, chronic migraine, schizophrenia)
• Current uncontrolled diabetes mellitus
• Significant cognitive impairment at Baseline that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to assess pain intensity and/or complete a pain diary
• Participated in any investigational study within 30 days prior to the Screening Visit or is currently participating in another clinical trial that may influence the data that will be collected for this study
• A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception
• Plan to receive any massage or manipulation directly over the leads or by the location of the IPG or treatments that involve sudden jerking motions of the torso at any time during the course of the study
• Unresolved active litigation related to the pain condition being treated in the study
• Currently involved in a worker's compensation claim
• Unable to operate the SCS System

Sponsors & Collaborators

• Algos Clinical Development Thomas L. Yearwood, MD, PhD: lead

Study Sites (1)

Comprehensive Pain and Rehabilitation

Pascagoula, Mississippi, 39581, United States

Location

Related Publications (1)

• Tiede J, Brown L, Gekht G, Vallejo R, Yearwood T, Morgan D. Novel spinal cord stimulation parameters in patients with predominant back pain. Neuromodulation. 2013 Jul-Aug;16(4):370-5. doi: 10.1111/ner.12032. Epub 2013 Feb 21.

  PMID: 23433237 BACKGROUND

Related Links

• Home Page for the Food and Drug Administration (FDA)
• WIRB sets the standard in the field of independent ethical review of biomedical research on human subjects.

MeSH Terms

Conditions

Back Pain; Bronchiolitis Obliterans Syndrome; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Thomas L Yearwood, MD, PhD

  Algos Cinical Development

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director / Principal Investigator

Study Record Dates

• First Submitted: October 30, 2013
• First Posted: November 6, 2013
• Study Start: October 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: January 19, 2015

Record last verified: 2015-01

Locations

US (1)