NCT02161627

Brief Summary

The aims of the study are to compare automatic control of spinal cord stimulation with manual control in patients with chronic pain of the trunk and limbs

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable chronic-pain

Timeline
Completed

Started Jul 2014

Shorter than P25 for not_applicable chronic-pain

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 12, 2014

Completed
19 days until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

October 3, 2016

Status Verified

September 1, 2016

Enrollment Period

10 months

First QC Date

June 6, 2014

Last Update Submit

September 30, 2016

Conditions

Chronic Pain

Keywords

spinal cord stimulationautomatic control

Outcome Measures

Primary Outcomes (1)

  • Percentage of Subjects With Improved Pain Relief and/or Stimulation Side Effects During the Automatic Control Arm Relative to the Manual Control Arm

    After subjects experience both automatic and manual control after 20 days, subjects are asked to compare pain relief and stimulation side effects between the two arms of the study (blinded) in two separate domains using two 5-point Likert scales. The outcome measure for the primary objective is the percentage of subjects who report improved pain relief with no worsening of stimulation side-effects or improved stimulation side-effects with no loss of pain relief during the automatic control arm relative to the manual control arm. These subjects were considered successful for the primary outcome.

    20 days

Secondary Outcomes (4)

  • Number of Adverse Events as a Measure of Safety

    20 days

  • Compare change from baseline of pain scores between automatic and manual control stimulation

    20 days

  • Compare change from baseline of quality of life scores, between automatic and manual control stimulation

    20 days

  • Compare patient satisfaction with stimulation as measured on a 5-point Likert scale between automatic and manual control stimulation

    20 days

Study Arms (2)

Automatic Control

EXPERIMENTAL

Automatic Control using Saluda Medical External Trial System

Device: Saluda Medical External Trial System

Manual Control

ACTIVE COMPARATOR

Manual Control using Saluda Medical External Trial System

Device: Saluda Medical External Trial System

Interventions

Saluda Medical External Trial SystemDEVICE
Automatic Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have been diagnosed with chronic, intractable pain of the trunk and/or limbs (VAS ≥ 5), which has been refractory to conservative therapy for a minimum of 3 months.
  • Have been approved to undergo a trial of SCS.
  • Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
  • Be on a stable dose (no new, discontinued, or changes in dose) of all prescribed pain medication for at least 4 weeks prior to the trial
  • Be 18 years of age or older at the time of enrollment
  • Be willing and capable of giving informed consent
  • Be willing and able to comply with study-related requirements, procedures, and visits
  • Females of childbearing age must have a negative urine pregnancy test at baseline

You may not qualify if:

  • Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
  • Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcomes
  • Are not a surgical candidate due to a diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus
  • Have a diagnosis of scoliosis that precludes lead placement
  • Have a condition, treatable with SCS, that requires leads to be inserted into the cervical region
  • Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker
  • Have a condition currently requiring or likely to require the use of MRI or diathermy
  • Have pain due to a malignant disease
  • Have a life expectancy of less than 1 year
  • Have an active systemic or local infection
  • Be allergic, or have shown hypersensitivity, to any materials of the neurostimulation system which come in contact with the body
  • Be pregnant or nursing (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal)
  • Have within 6 months of enrollment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and/or illicit drugs)
  • Be concomitantly participating in another clinical study
  • Be involved in an injury claim under current litigation
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

The Pain Center of Arizona

Phoenix, Arizona, 85027, United States

Location

Arizona Pain Specialists

Scottsdale, Arizona, 85258, United States

Location

Center for Neurosciences

Tucson, Arizona, 85718, United States

Location

Premier Pain Management

Shrewsbury, New Jersey, 07702, United States

Location

University Pain Management Center

Somerset, New Jersey, 08873, United States

Location

Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

St Luke's Hospital, Neurosurgical Associates

Bethlehem, Pennsylvania, 18015, United States

Location

Performance Spine & Sports Physicians

East Norriton, Pennsylvania, 19403, United States

Location

Fox Chase Pain Management

Feasterville-Trevose, Pennsylvania, 19053, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael J Cousins, MD DSc

    Pain Management Research Institute and Kolling Institute, University of Sydney at the Royal North Shore Hospital

    PRINCIPAL INVESTIGATOR

  • Ashwini Sharan, MD

    Department of Neurosurgery, Thomas Jefferson University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2014

First Posted

June 12, 2014

Study Start

July 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

October 3, 2016

Record last verified: 2016-09

Locations

US(10)