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

NCT ID: NCT02161627

Last Updated: 2016-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-05-31

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

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.

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Automatic Control

Automatic Control using Saluda Medical External Trial System

Group Type: EXPERIMENTAL

Saluda Medical External Trial System

Intervention Type: DEVICE

Manual Control

Manual Control using Saluda Medical External Trial System

Group Type: ACTIVE_COMPARATOR

Saluda Medical External Trial System

Intervention Type: DEVICE

Interventions

Saluda Medical External Trial System

Intervention Type: DEVICE

Saluda Medical External Trial System

Intervention Type: DEVICE

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saluda Medical Pty Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael J Cousins, MD DSc

Role: PRINCIPAL_INVESTIGATOR

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

Ashwini Sharan, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurosurgery, Thomas Jefferson University Hospital

Locations

The Pain Center of Arizona

Phoenix, Arizona, United States

Arizona Pain Specialists

Scottsdale, Arizona, United States

Center for Neurosciences

Tucson, Arizona, United States

Premier Pain Management

Shrewsbury, New Jersey, United States

University Pain Management Center

Somerset, New Jersey, United States

Center for Clinical Research

Winston-Salem, North Carolina, United States

St Luke's Hospital, Neurosurgical Associates

Bethlehem, Pennsylvania, United States

Performance Spine & Sports Physicians

East Norriton, Pennsylvania, United States

Fox Chase Pain Management

Feasterville-Trevose, Pennsylvania, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

U1111-1157-5143

Identifier Type: OTHER

Identifier Source: secondary_id

SBWSH1302

Identifier Type: -

Identifier Source: org_study_id