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

Chronic Pain Clinical Trial

— Panorama  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02161627
• Other study ID #: SBWSH1302
• Secondary ID: U1111-1157-5143
• Status: Completed
• Phase: N/A
• First received: June 6, 2014
• Last updated: September 30, 2016
• Start date: July 2014
• Est. completion date: May 2015

Study information

• Verified date: September 2016
• Source: Saluda Medical Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Device:
• Saluda Medical External Trial System

• Saluda Medical External Trial System

Locations

Country	Name	City	State
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	The Pain Center of Arizona	Phoenix	Arizona
United States	Arizona Pain Specialists	Scottsdale	Arizona
United States	Premier Pain Management	Shrewsbury	New Jersey
United States	University Pain Management Center	Somerset	New Jersey
United States	Center for Neurosciences	Tucson	Arizona
United States	Center for Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Saluda Medical Pty Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of Adverse Events as a Measure of Safety		20 days	Yes
Secondary	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	No
Secondary	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	No
Secondary	Compare patient satisfaction with stimulation as measured on a 5-point Likert scale between automatic and manual control stimulation		20 days	No