Subcutaneous Nerve Stimulation for Failed Back Surgery Syndrome (FBSS) Patients

Failed Back Surgery Syndrome Clinical Trial

— SubQStim  

Official title:

SubQStim Pivotal Study: A Prospective, Randomized, Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Nerve Stimulation. Protocol 1666

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01818297
• Other study ID #: 1666
• Secondary ID: G120146
• Status: Terminated
• Phase: N/A
• First received: March 21, 2013
• Last updated: September 19, 2017
• Start date: April 2013
• Est. completion date: March 2016

Study information

• Verified date: September 2017
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety and efficacy of Subcutaneous Nerve Stimulation (SQS) (also known as Peripheral Nerve Stimulation [PNS]) in the reduction of chronic, intractable post-surgical back pain in adults.

Description:

This study is a multi-center, prospective, randomized (1:1) parallel-group design.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 137
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Key Inclusion Criteria:

• Have persistent back pain for at least 6 months

• Had back surgery at least 6 months ago

• Have tried pain medications and physical therapy

• Read and understand written English or Spanish

• Male or non-pregnant female. If female of child-bearing potential, and if sexually active, must be using a medically-acceptable method of birth control during study participation

• Willing and able to undergo surgical implant procedure, attend visits as scheduled, and comply with the study requirements

• Have an expected lifespan greater than 12 months

Key Exclusion Criteria:

• Have leg pain in addition to back pain.

• Currently enrolled in or plan to enroll in another drug and/or device study

• Have peripheral vascular disease, peripheral neuropathy, small-fiber neuropathy, or fibromyalgia

• Have an active systemic infection or are immunocompromised

• Will be exposed to diathermy or anticipate needing a full-body MRI scan

• Currently have an implantable cardiac pacemaker, defibrillator, or neurostimulator

• Treated with spinal cord stimulation, peripheral nerve stimulation, an intrathecal drug delivery system or requires additional back surgery

Related Conditions & MeSH terms

• Failed Back Surgery Syndrome
• Post-laminectomy Syndrome
• Postoperative Complications
• Spinal Diseases
• Syndrome

Intervention

Device:
• PrimeAdvanced® neurostimulator system
Neurostimulator and associated components

Locations

Country	Name	City	State
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Coastal Pain Research	Carlsbad	California
United States	Austin Pain Associates	Cedar Park	Texas
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Mayfield Clinic	Cincinnati	Ohio
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	Columbia Interventional Pain Center, LLP	Columbia	Missouri
United States	Ohio State University	Columbus	Ohio
United States	Summa Western Reserve Hospital	Cuyahoga Falls	Ohio
United States	Pain Medicine Associates	Fountain Valley	California
United States	Wisconsin Health Center Surgery Center	Greenfield	Wisconsin
United States	DNA Advanced Pain Treatment Center	Greensburg	Pennsylvania
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Florida Pain Institute	Merritt Island	Florida
United States	Advanced Medicine and Pain Management Research	Miami	Florida
United States	Southern Spine Institute	Mount Pleasant	South Carolina
United States	NYU Langone Medical Center	New York	New York
United States	Compass Research, LLC	Orlando	Florida
United States	Comprehensive Pain and Rehabilitation	Pascagoula	Mississippi
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	HOPE Research Institute	Phoenix	Arizona
United States	Valley Pain Consultants	Phoenix	Arizona
United States	Lifetree Clinical Research	Salt Lake City	Utah
United States	Willis Knighton River Cities Clinical Research Center	Shreveport	Louisiana
United States	Mercy Medical Research Institute	Springfield	Missouri
United States	Space City Pain Specialists	Webster	Texas

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Back Pain Responders (Subjects Who Achieve at Least a 50% Reduction in Average Back Pain With no Increase in Prescription Pain Medications) From Baseline to Month 3 Post-device Activation.	Number of responders in Treatment and Control groups. Subjects reported typical back pain (0=no pain, 10=worst pain) during the Baseline (BL) and Blinded Phase (M3) periods. Percentage reduction in average back pain was calculated as (BL-M3)/BL. Subjects with at least a 50% reduction in average back pain between Baseline and Month 3, with no increase in prescribed pain medications, were considered responders.	Baseline to 3 months
Secondary	Functional Disability	Compare the difference in average improvement in disability (as measured by Oswestry Disability Index (ODI)) from Baseline to Month 3 between the Treatment and Control groups. ODI ranges from 0% (no disability) -100% (greatest disability). Change is calculated as Baseline - Month 3 with a positive change indicating improvement in disability. Subjects with missing Baseline and/or Month 3 ODI assessments were counted as no change (Baseline - Month 3 = 0).	Baseline to 3 months
Secondary	Subject Satisfaction	Compare difference in number of subjects satisfied with therapy between the Treatment and Control groups at Month 3. Subjects who reported they were very or somewhat satisfied with the therapy were counted as satisfied. Subjects with no satisfaction response were excluded from the analysis.	3 months
Secondary	Quality of Life: Physical	Compare the average change in quality of life (as measured by Short Form Health Survey (SF36 v2): Physical component score (PCS)) from Baseline to Month 3 between subjects in the Treatment and Control groups. The PCS ranges from 0 (worst possible physicial quality of life) to 100 (best possible physical quality of life). Change was calculated as Month 3 - Baseline, with a positive difference indicating improvement in physical quality of life. Subjects with missing Baseline and/or Month 3 SF-36: PCS assessments were counted as no change (Month 3 - Baseline = 0).	Baseline to 3 months
Secondary	Quality of Life: Mental	Compare the average change in quality of life (as measured by Short Form Health Survey (SF36 v2): Mental component score (MCS)) from Baseline to Month 3 between subjects in the Treatment and Control groups. The MCS ranges from 0 (worst possible mental quality of life) to 100 (best possible mental quality of life). Change was calculated as Month 3 - Baseline, with a positive difference indicating improvement in mental quality of life. Subjects with missing Baseline and/or Month 3 SF-36: MCS assessments were counted as no change (Month 3 - Baseline = 0).	Baseline to 3 months
Secondary	Worst Back Pain	Compare the average improvement in worst back pain from Baseline to Month 3 between the Treatment and Control groups. Subjects reported worst back pain (0 (no pain) - 10 (worst pain)) during the Baseline and Blinded Phase (Month 3) periods. Change was calculated as Baseline - Month 3, with a positive change indicating improvement in worst back pain.	Baseline to 3 months