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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Saluda Medical Pty Ltd
ClinicalTrials.gov Identifier:
NCT02161627
First received: June 6, 2014
Last updated: September 30, 2016
Last verified: September 2016
  Purpose
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

Condition Intervention
Chronic Pain Device: Saluda Medical External Trial System

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Saluda Medical Pty Ltd:

Primary Outcome Measures:
  • Percentage of Subjects With Improved Pain Relief and/or Stimulation Side Effects During the Automatic Control Arm Relative to the Manual Control Arm [ Time Frame: 20 days ]
    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.


Secondary Outcome Measures:
  • Number of Adverse Events as a Measure of Safety [ Time Frame: 20 days ]
  • Compare change from baseline of pain scores between automatic and manual control stimulation [ Time Frame: 20 days ]
    Pain scores are obtained from the Visual Analog Scale (VAS) administered at baseline and after each arm of the study

  • Compare change from baseline of quality of life scores, between automatic and manual control stimulation [ Time Frame: 20 days ]
    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

  • Compare patient satisfaction with stimulation as measured on a 5-point Likert scale between automatic and manual control stimulation [ Time Frame: 20 days ]

Enrollment: 69
Study Start Date: July 2014
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02161627

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

Responsible Party: Saluda Medical Pty Ltd
ClinicalTrials.gov Identifier: NCT02161627     History of Changes
Other Study ID Numbers: SBWSH1302
U1111-1157-5143 ( Other Identifier: World Health Organization - Universal Trial Number )
Study First Received: June 6, 2014
Last Updated: September 30, 2016

Keywords provided by Saluda Medical Pty Ltd:
spinal cord stimulation
automatic control

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 21, 2017