- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02128672
Spinal Stimulation to Treat Low Back Pain
Extraforaminal Spinal Stimulation Compared to Conventional Spinal Cord Stimulation to Treat Axial Low Back Pain-A Pilot Study
Spinal cord stimulation (SCS) has been used for almost 30 years to treat many intractable back pain conditions. It has demonstrated efficacy in the co-called Failed Back Surgery Syndrome (FBSS) and a recent randomized controlled trial demonstrated significant superiority of SCS over conventional medical therapy to treat patients with FBSS. Another trial has demonstrated superiority of SCS over repeat surgery in the same patient population. However, the ability to reliably capture the low back with paresthesia coverage has remained challenging and elusive despite numerous strategies designed to overcome this limitation. Strategies that have been introduced but so far with limited success include transverse multiple lead stimulation, high frequency stimulation, peripheral field stimulation, and dorsal root ganglion (DRG) stimulation. To date, none of these strategies have been able to reliably overcome the long-term problems of paresthesia capture and pain relief of the low back.
This proposal describes a new spinal stimulation technique designed to improve the likelihood of low back stimulation by targeting the nerve supply to the two most commonly affected pain producing structures in the back, the facet joints and the intervertebral disks. The technique has proven to be feasible in a cadaver model with ease of lead placement at the desired targets
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion:
- Patients with one sided low back pain
- Failed standard conservative care including medications, physical therapy, and/or injections
- Pain greater than 6 months
Exclusion:
- Pregnancy
- Previous spine surgery
- Pain radiating beyond/below the knee
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Conventional SCS lead
Conventional Thoracic-lumbar SCS lead placement
|
|
Experimental: SCS Experimental Lead Placement
Experimental SCS lead placement in a novel position
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Did the participant have paresthesia coverage from the stimulation?
Time Frame: Baseline to 4 days
|
This is a simple yes or no outcome.
Either the patient is able to feel the stimulation paresthesia in the area of his or her back where he or she has pain (outcome is yes) or they do not feel it (outcome is no).
|
Baseline to 4 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric Pain Rating Scale (NRS)
Time Frame: Baseline to 4 days
|
NRS is a validated back pain outcome scale
|
Baseline to 4 days
|
Patient preferred stimulation-Likert Scale
Time Frame: baseline to 4 days
|
baseline to 4 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tim Lamer, MD, Mayo Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-003985
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Low Back Pain
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Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Faculdade de Ciências Médicas da Santa Casa de...CompletedLow Back Pain, Mechanical | Low Back Pain, Postural | Lower Back Pain Chronic | Low Back Pain, Posterior CompartmentBrazil
-
University School of Physical Education in WroclawCompletedLow Back Pain | Low Back Pain, Mechanical | Low Back Pain, PosturalPoland
-
Texas Woman's UniversityTexas Physical Therapy AssociationCompletedLow Back Pain | Chronic Low Back Pain | Subacute Low Back PainUnited States
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University of ParmaKing's College London; Helmholtz Zentrum München; GENOS; Ip Research Consulting... and other collaboratorsUnknownChronic Low Back Pain | Acute Low Back PainUnited States, Australia, Belgium, Croatia, Italy, United Kingdom
-
Apsen Farmaceutica S.A.CompletedLow Back Pain | Low Back Pain, Mechanical | Acute Low Back PainBrazil
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Universidade Federal do PiauíFoundation for Research Support of the State of PiauíCompletedLow Back Pain, Recurrent | Chronic Low Back PainBrazil
-
Washington University School of MedicineEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedChronic Low Back Pain | Mechanical Low Back PainUnited States
-
University of ExtremaduraCompletedChronic Low Back Pain | Postural Low Back PainSpain
-
Université du Québec à Trois-RivièresCompletedChronic Low Back Pain | Mechanical Low Back PainCanada
Clinical Trials on Spinal Cord Stimulator Lead Placement
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Boston Scientific CorporationTerminatedBack Pain | Chronic Pain | Pain in Leg, UnspecifiedUnited States
-
Abbott Medical DevicesCompletedChronic, Intractable Pain of the Trunk and/or Lower LimbsUnited States, Australia, Netherlands, Sweden, Germany, Italy, Austria
-
Carolinas Center for Advanced Management of PainAbbott Medical DevicesCompleted
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Stimwave TechnologiesAZ Delta; GZA Ziekenhuizen Campus Sint-AugustinusActive, not recruiting
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Kristin Zhao, PhDWithdrawnParaplegia, Spinal | Paraplegia, Complete | Paraplegia; Traumatic
-
Ashwin ViswanathanBoston Scientific CorporationNot yet recruitingChronic Pain | Neuropathic Pain | Pain, NeuropathicUnited States
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The Center for Clinical Research, Winston-Salem...UnknownChronic PainUnited States
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University of California, DavisCompletedPost-laminectomy Syndrome | Axial Back PainUnited States
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University Hospitals Cleveland Medical CenterRecruitingLow Back Pain | LipomatosisUnited States
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Lee Fisher, PhDNational Institute of Neurological Disorders and Stroke (NINDS)RecruitingPhantom Limb Pain | Traumatic Amputation of Lower ExtremityUnited States