NCT01446419

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2011

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
8 months until next milestone

Results Posted

Study results publicly available

October 31, 2016

Completed
Last Updated

October 31, 2016

Status Verified

October 1, 2016

Enrollment Period

3.4 years

First QC Date

October 3, 2011

Results QC Date

July 12, 2016

Last Update Submit

October 24, 2016

Conditions

Low Back Pain

Keywords

chronic axial low back painvertebrogenic painRadio frequency ablation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Patient Success at 3 Months

    3 months

  • Change in ODI From Baseline to 6 Months Post-treatment

    6 months

Study Arms (2)

Intracept Treatment

EXPERIMENTAL
Device: Intracept Treatment

Sham Treatment

SHAM COMPARATOR
Device: Sham Treatment

Interventions

Intracept TreatmentDEVICE

Percutaneous transpedicular RF ablation of an intraosseous nerve within the lumbar vertebral body to treat chronic axial low back.

Intracept Treatment
Sham TreatmentDEVICE

Percutaneous transpedicular access to the lumbar vertebra, no RF ablation delivered.

Sham Treatment

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • 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

You may not qualify if:

  • 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:
  • Nerve root compression or severe effacement of the thecal sac that correlates with radicular pain or muscle weakness
  • Disc extrusion or disc protrusion \>5mm
  • Facet arthrosis or facet effusion at any lumbar level that correlates with clinical evidence of facet mediated low back pain
  • Spondylolisthesis 2mm or greater at any level
  • Spondylolysis at any level
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Desert Institute for Spine Care

Phoenix, Arizona, 85020, United States

Location

SpineCare Medical Group

Daly City, California, 94015, United States

Location

Memorial Orthopedic Surgical Group

Long Beach, California, 90806, United States

Location

The Spine Institute

Santa Monica, California, 90403, United States

Location

Pain Center Solutions

Marietta, Georgia, 30060, United States

Location

Indiana Spine Group

Carmel, Indiana, 46032, United States

Location

Maine Medical Partners

Scarborough, Maine, 04074, United States

Location

Partners in Research and Educational Studies of Spinal Disorders (PressD)

Southfield, Michigan, 48033, United States

Location

OrthoCarolina

Charlotte, North Carolina, 28207, United States

Location

NeuroSpine Institute

Eugene, Oregon, 97401, United States

Location

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Seton Spine & Scoliosis Center

Austin, Texas, 78731, United States

Location

Virginia iSpine Physicians

Richmond, Virginia, 23235, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
V.P. of Clinical & Regulatory Affairs
Organization
Relievant Medsystems, Inc.
lhook@relievant.com
650-261-2259

Study Officials

  • Jeffrey Fischgrund, MD

    Michigan Orthopaedic Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2011

First Posted

October 5, 2011

Study Start

October 1, 2011

Primary Completion

March 1, 2015

Study Completion

March 1, 2016

Last Updated

October 31, 2016

Results First Posted

October 31, 2016

Record last verified: 2016-10

Locations

US(13)