Safety and Effectiveness of Spinal Cord Stimulation With Automatic Control to Treat Chronic Pain in an Extended Trial (Panorama)

Prospective, Multicenter, Randomized Double-blind Crossover Study Examining the Safety and Effectiveness of Spinal Cord Stimulation Incorporating Feedback to Treat Patients With Chronic Pain of the Trunk and/or Limbs in an Extended Trial

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

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Device: Saluda Medical External Trial System

Detailed Description

Subjects will use the Saluda Medical External Trial System to compare automatic control of spinal cord stimulation with manual control in a randomized, blinded, crossover study.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85027
      • The Pain Center of Arizona
    • Scottsdale, Arizona, United States, 85258
      • Arizona Pain Specialists
    • Tucson, Arizona, United States, 85718
      • Center for Neurosciences
  • New Jersey
    • Shrewsbury, New Jersey, United States, 07702
      • Premier Pain Management
    • Somerset, New Jersey, United States, 08873
      • University Pain Management Center
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Center for Clinical Research
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • St Luke's Hospital, Neurosurgical Associates
    • East Norriton, Pennsylvania, United States, 19403
      • Performance Spine & Sports Physicians
    • Feasterville-Trevose, Pennsylvania, United States, 19053
      • Fox Chase Pain Management
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Patients enrolled in this study must meet the following inclusion criteria:

1. 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.
2. Have been approved to undergo a trial of SCS.
3. Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
4. 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
5. Be 18 years of age or older at the time of enrollment
6. Be willing and capable of giving informed consent
7. Be willing and able to comply with study-related requirements, procedures, and visits
8. Females of childbearing age must have a negative urine pregnancy test at baseline

Exclusion Criteria:

Patients enrolled in this study must not meet the following exclusion criteria:

1. 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
2. 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
3. Are not a surgical candidate due to a diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus
4. Have a diagnosis of scoliosis that precludes lead placement
5. Have a condition, treatable with SCS, that requires leads to be inserted into the cervical region
6. Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker
7. Have a condition currently requiring or likely to require the use of MRI or diathermy
8. Have pain due to a malignant disease
9. Have a life expectancy of less than 1 year
10. Have an active systemic or local infection
11. Be allergic, or have shown hypersensitivity, to any materials of the neurostimulation system which come in contact with the body
12. 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)
13. 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)
14. Be concomitantly participating in another clinical study
15. Be involved in an injury claim under current litigation
16. Have a pending or approved worker's compensation claim

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Automatic Control; Automatic Control using Saluda Medical External Trial System	Device: Saluda Medical External Trial System
Active Comparator: Manual Control; Manual Control using Saluda Medical External Trial System	Device: Saluda Medical External Trial System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Adverse Events as a Measure of Safety		20 days
Compare change from baseline of pain scores between automatic and manual control stimulation	Pain scores are obtained from the Visual Analog Scale (VAS) administered at baseline and after each arm of the study	20 days
Compare change from baseline of quality of life scores, between automatic and manual control stimulation	Quality of life scores are obtained from the Short Form - 36 (SF-36), and EuroQol-5D-5L questionnaires administered at baseline and after each arm of the study	20 days
Compare patient satisfaction with stimulation as measured on a 5-point Likert scale between automatic and manual control stimulation		20 days

Collaborators and Investigators

• Sponsor: Saluda Medical Pty Ltd
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: June 6, 2014
• First Submitted That Met QC Criteria: June 11, 2014
• First Posted (Estimate): June 12, 2014

Study Record Updates

• Last Update Posted (Estimate): October 3, 2016
• Last Update Submitted That Met QC Criteria: September 30, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: spinal cord stimulation; automatic control
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: SBWSH1302; U1111-1157-5143 (Other Identifier: World Health Organization - Universal Trial Number)