A Safety and Effectiveness Trial of Spinal Cord Stimulation of the Dorsal Root Ganglion for Chronic Lower Limb Pain

Chronic Lower Limb Pain Clinical Trial

— ACCURATE  

Official title:

A Prospective, Randomized, Multi-Center, Controlled Clinical Trial to Assess the Safety and Efficacy of the Spinal Modulation™ AXIUM™ Neurostimulator System in the Treatment of Chronic Pain (ACCURATE Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01923285
• Other study ID #: 03-SMI-2012
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: September 2016

Study information

• Verified date: November 2020
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and effectiveness of the AXIUM Neurostimulator System for the treatment of chronic lower limb pain in persons diagnosed with Complex Regional Pain Syndrome (CRPS) or Peripheral Causalgia (PC).

Description:

The ACCURATE study is a prospective, randomized, controlled, multicenter clinical trial designed to assess the safety and efficacy of the Spinal Modulation Axium Neurostimulator System as an aid in the management of chronic, intractable pain of the lower limbs, including unilateral or bilateral pain associated with one of the following conditions: Complex Regional Pain Syndrome (CRPS) or Peripheral Causalgia (also referred to as CRPS Type II).

Enrolled subjects were diagnoses with CRPS or peripheral causalgia; experienced pain for at least six months; and failed to achieve adequate pain relief from at least two prior pharmacologic treatments.

All subjects had a temporary trial neurostimulator (TNS). If the subject was a treatment success at the end of TNS they were scheduled for the fully implantable neurostimulator (INS) implant procedure. If not, subjects were exited from the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Subject is male or female between the ages of 22 and 75 years

2. Subject is able and willing to comply with the follow-up schedule and protocol

3. Subject has chronic, intractable pain of the lower limb(s) for at least 6 months

4. Subjects are diagnosed with complex regional pain syndrome (CRPS) and/or peripheral causalgia

5. Subjects have a minimum Visual Analog Scale (VAS) greater than or equal to 60 mm in the area of greatest pain in the lower limbs.

6. Subject has failed to achieve adequate pain relief from at least 2 prior pharmacologic treatments from at least 2 different drugs classes

7. Subject has had stable neurologic function in the past 30 days

8. In the opinion of the Investigator, the subject is psychologically appropriate for the implantation of an active implantable medical device

9. Subject is able to provide written informed consent

Exclusion Criteria:

1. Back pain is the greatest region of pain as measured on the baseline VAS.

2. Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control

3. Subject has exhibited escalating or changing pain condition within the past 30 days as evidenced by Investigator examination

4. Subject is currently involved in medically related litigation, including workers compensation

5. Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days

6. Subject's pain medication(s) dosage(s) are not stable for at least 30 days

7. Subject has had radiofrequency treatment of an intended target Dorsal Root Ganglion within the past 3 months

8. Subject has previously failed spinal cord stimulation therapy

9. Subject currently has an active implantable device including implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump or subject requires magnetic resonance imaging (MRIs) or diathermy

10. Subject has pain only within a cervical distribution

11. Subject has cognitive, physical or sensory impairment that, in the opinion of the Investigator, may limit their ability to operate the device

12. Subject currently has an indwelling device that may pose an increased risk of infection

13. Subject currently has an active systemic infection.

14. Subject has, in the opinion of the investigator, a medical comorbidity that contraindicates placement of an active medical device

15. Subject has participated in another clinical investigation within 30 days

16. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the Investigator, precludes participation

17. Subject has been diagnosed with cancer in the past 2 years

18. Imaging (MRI, CT, x-ray) findings within the last 12 months that, in the Investigator's opinion, contraindicates lead placement

19. Subject is a prisoner

Related Conditions & MeSH terms

• Chronic Lower Limb Pain

Intervention

Device:
• AXIUM Neurostimulator System

• Control Spinal Cord Stimulation Device

Locations

Country	Name	City	State
United States	Pain Clinic of Monterey Bay	Aptos	California
United States	Coastal Pain Research	Carlsbad	California
United States	Center for Pain Relief	Charleston	West Virginia
United States	Clinical Trials of South Carolina	Charleston	South Carolina
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Houston Pain Centers	Houston	Texas
United States	Center for Pain Relief Tri-State	Huntington	West Virginia
United States	Pain Management Associates	Independence	Missouri
United States	HOPE Research - LVSP	Las Vegas	Nevada
United States	Drug Studies of America	Marietta	Georgia
United States	Florida Pain Institute	Merritt Island	Florida
United States	Southeastern Spine Institute	Mount Pleasant	South Carolina
United States	Neurovations, Inc.	Napa	California
United States	Newport Beach Headache and Pain	Newport Beach	California
United States	Holy Cross Hospital Orthopedic Institute	Oakland Park	Florida
United States	Comprehensive Pain and Rehabilitation	Pascagoula	Mississippi
United States	HOPE Research - TPC	Phoenix	Arizona
United States	Eisenhower Medical Center	Rancho Mirage	California
United States	Orthopaedic Pain Specialists	Santa Monica	California
United States	Premier Pain Center	Shrewsbury	New Jersey
United States	IPM Medical Group, Inc.	Walnut Creek	California
United States	The Center for Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Primary Composite Endpoint - Treatment Success for Only Those Subjects With a Permanent Implant	Treatment Success is defined as a reduction in pain score greater than or equal to 50 percent and the absence of a stimulation related neurological deficit. Pain scores were measured using Visual Analog Scale (VAS). The VAS score ranges from 0-100 mm with a higher score indicating higher pain intensity ( 0 representing "No Pain" and 100 mm representing "Worst Imaginable Pain").	3 months
Other	Primary Composite Endpoint - Treatment Success for Only Those Subjects With a Permanent Implant	Treatment Success is defined as a reduction in pain score greater than or equal to 50 percent and the absence of a stimulation related neurological deficit. Pain scores were measured using Visual Analog Scale (VAS). The VAS score ranges from 0-100 mm with a higher score indicating higher pain intensity ( 0 representing "No Pain" and 100 mm representing "Worst Imaginable Pain").	12 months
Primary	Primary Composite Endpoint - Treatment Success	Treatment Success is defined as at least 50% lower limb pain relief (VAS score reduction) at the end of trial phase, received at least 50% lower limb pain relief at the 3-month visit post implant, and the absence of a stimulation related neurological deficit. Pain scores were measured using Visual Analog Scale (VAS). The VAS score ranges from 0-100 mm with a higher score indicating higher pain intensity ( 0 representing "No Pain" and 100 mm representing "Worst Imaginable Pain").	3 months
Secondary	Positional Effects on Paresthesia Intensities	Positional effects on paresthesia intensities at 3 months in the Control group versus the Treatment Group. This endpoint will compare the difference in paresthesia scores upright and supine between the AXIUM and Control groups. Paresthesia intensity was rated by subjects using a paresthesia intensity rating scale. Subjects rated the intensity of their perception of paresthesia, while upright and supine, on an 11-point numeric rating scale from 0 representing "No feeling" to 10 "Very intense." Perceived paresthesia intensity difference between supine and upright positions was calculated and averaged across each group.	3 months