Failed Back Surgery Syndrome Clinical Trial
— SubQStimOfficial title:
SubQStim Pivotal Study: A Prospective, Randomized, Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Nerve Stimulation. Protocol 1666
Verified date | September 2017 |
Source | MedtronicNeuro |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
MedtronicNeuro |
United States,
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 |
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