SMART Clinical Study: Surgical Multi-center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain

Low Back Pain Clinical Trial

— SMART  

Official title:

A Prospective Randomized, Double-blind, Controlled Investigation Evaluating the Intracept Intraosseous Nerve Ablation System for the Reduction of Pain in Patients With Chronic Axial Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01446419
• Other study ID #: CIP 0003
• Status: Completed
• Phase: N/A
• First received: October 3, 2011
• Last updated: October 24, 2016
• Start date: October 2011
• Est. completion date: March 2016

Study information

• Verified date: October 2016
• Source: Relievant Medsystems, Inc.
• 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

To evaluate the safety and efficacy of RF ablation using the Intracept Intraosseous Nerve Ablation System to ablate intraosseous nerves for the relief of chronic axial low back pain. This is a prospective, double-blind, randomized, sham-controlled clinical trial with an optional crossover component.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: March 2016
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 70 Years

Eligibility

Inclusion Criteria:

• Skeletally mature patients age 25 - 70 years, inclusive

• Chronic lower back pain for at least six (6) months

• Failure to respond to at least six (6) months of non-operative conservative management. The minimum requirement is as follows:

• Analgesic therapy (minimum of 2 weeks) and a minimum of 4 weeks of NSAID therapy

• Supervised exercise program(minimum of 12 sessions)

• Oswestry Disability Index (ODI) at time of evaluation of at least 30 points

• Baseline Visual Analog Scale (VAS) of at least 4cm on a 10cm scale

• The following test indicating that the vertebral body is the source of pain:

1.MRI showing Type 1 or Type II Modic changes at least one vertebral endplate, at one or more levels from L3 to S1

• Understands the local language and is willing and able to follow the requirements of the protocol

• Understands the informed consent and signs the institutional review board/ independent ethics committee (IRB/IEC) approved informed consent form

Exclusion Criteria:

• Radicular pain by history or evidence of pain or neurological deficit in a dermatomal zone at or below the medial thigh.

• Previous surgery performed on the lumbar spine

• History of symptomatic spinal stenosis

• History of osteoporotic or tumor-related vertebral body compression fracture

• History of vertebral cancer or spinal metastasis

• History of spinal infection

• Metabolic bone disease (e.g. osteogenesis imperfecta)

• BMI =40

• Osteoporosis, defined as T score <-2.5

• Any radiographic evidence of other important back pathology, such as:

1. Nerve root compression or severe effacement of the thecal sac that correlates with radicular pain or muscle weakness

2. Disc extrusion or disc protrusion >5mm

3. Facet arthrosis or facet effusion at any lumbar level that correlates with clinical evidence of facet mediated low back pain

4. Spondylolisthesis 2mm or greater at any level

5. Spondylolysis at any level

• MRI evidence of Modic changes, Type I or Type II at greater than 3 vertebral bodies.

• Any back pathology related to trauma, evidence of vertebral compression fracture or other spinal pathology that could affect assessment of response to back pain

• Demonstrates 3 or more Waddell's signs of Inorganic Behavior

• Any evidence of current systemic infection

• Uncorrected bleeding diathesis

• Any neurologic problem that prevents early mobilization after surgery or interferes with assessment of ODI

• Contraindication to MRI or patients who have allergies to the components of the Intracept device

• Pregnant, lactating or plan to become pregnant in next year

• Diabetes requiring daily insulin

• Current use of steroid therapy, with the exception of inhalation steroids for asthma

• Evidence of mental instability or uncontrolled depression; patients requiring anti-depressants or anti-psychotics within 3 months of enrollment are not eligible; patients with a Beck Depression Score of greater than 24 are not eligible

• Receiving Workmen's Compensation

• Currently involved in litigation regarding back pain/injury or financial incentive to remain impaired

• Any medical condition that impairs follow-up

• Contraindications to the proposed anesthetic protocol.

• Evidence of substance abuse; patients using prescribed extended release narcotics are not eligible (e.g. fentanyl patch,MS contin, oxycontin)

• Known to require at the time of screening and/or randomization, additional surgery to the lumbar spinal region within six months

• Being treated with radiation, chemotherapy, immunosuppression, or chronic steroid therapy (prednisone use up to 5 mg/qd or its equivalent is allowed)

• Has a life expectancy of less than 1 year

• Has active implantable devices, such as cardiac pacemakers, spinal cord stimulators, etc.

• Is a prisoner

Study Design

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Device:
• Intracept Treatment
Percutaneous transpedicular RF ablation of an intraosseous nerve within the lumbar vertebral body to treat chronic axial low back.
• Sham Treatment
Percutaneous transpedicular access to the lumbar vertebra, no RF ablation delivered.

Locations

Country	Name	City	State
United States	Seton Spine & Scoliosis Center	Austin	Texas
United States	Indiana Spine Group	Carmel	Indiana
United States	OrthoCarolina	Charlotte	North Carolina
United States	SpineCare Medical Group	Daly City	California
United States	NeuroSpine Institute	Eugene	Oregon
United States	Memorial Orthopedic Surgical Group	Long Beach	California
United States	Pain Center Solutions	Marietta	Georgia
United States	Rothman Institute	Philadelphia	Pennsylvania
United States	Desert Institute for Spine Care	Phoenix	Arizona
United States	Virginia iSpine Physicians	Richmond	Virginia
United States	The Spine Institute	Santa Monica	California
United States	Maine Medical Partners	Scarborough	Maine
United States	Partners in Research and Educational Studies of Spinal Disorders (PressD)	Southfield	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Relievant Medsystems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ODI From Baseline to 3 Months Post-treatment	The primary variable is the Oswestry Disability Index (ODI) and the primary efficacy endpoint is the mean improvement from baseline to 3 months in the ODI. The primary endpoint will be evaluated in both the treatment and sham groups with between-group comparisons used to assess the success of the Intracept System in reducing chronic axial low back pain.; ODI is a patient questionnaire that assesses back dysfunction due to back pain. There are 10 questions that are scored from 0-5. The obtained score is multiplied by 2 to produce a percentage score that is reported on a scale of 0-100. Scores are interpreted as follows: 0-20% minimum disability; 21-40% moderate disability; 41-60% severe disability; 61-80% crippled; 81-100% bed bound or exaggerating their symptoms.	3 months	No
Secondary	Patient Success at 3 Months	Proportion of subjects with clinical success at 3 months, where clinical success was defined as: 3 month ODI score represented at least a 15-point reduction from baseline; no device or procedure related SAE between baseline and 3 mos.; no increase in opioid use between procedure and 3 mos.; no deficit in a motor or dermatomal sensory group at the treated level at 3 mos.; no operative interventions or invasive procedures for lumbar back pain by a pain management or spinal specialist between procedure and 3 mos.	3 months	No
Secondary	Change in ODI From Baseline to 6 Months Post-treatment	The improvement in ODI at 6 months compared to baseline.; ODI is a patient questionnaire that assesses back dysfunction due to back pain. There are 10 questions that are scored from 0-5. The obtained score is multiplied by 2 to produce a percentage score that is reported on a scale of 0-100. Scores are interpreted as follows: 0-20% minimum disability; 21-40% moderate disability; 41-60% severe disability; 61-80% crippled; 81-100% bed bound or exaggerating their symptoms.	6 months	No