Five-Plus Year Follow-Up of SMART Randomized Controlled Trial

Completed

Conditions studied: Chronic Low Back Pain

In brief

The objective of this study is to evaluate long-term ongoing effectiveness of the Intracept Intraosseous Nerve Ablation System for the treatment of chronic low back pain.

Key facts

Study ID

NCT03997825

Run by

Relievant Medsystems, Inc.

People needed

117

Starts

2019-06-13

Expected to finish

2019-11-08

Last updated by the study team

2021-01-13

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• LBP at least 6 months from original SMART Trial
• RF Ablation Arm from SMART Trial

You may not qualify if…

• Control Arm Subjects from SMART Trial

Where it is running

• Desert Institute for Spine Care — Phoenix, Arizona, United States
• SpineCare Medical Group — Daly City, California, United States
• Memorial Orthopedic Surgical Group — Long Beach, California, United States
• Cedars Sinai Spine Center — Los Angeles, California, United States
• Drug Studies of America — Marietta, Georgia, United States
• Indiana Spine Group — Carmel, Indiana, United States
• Maine Medical Partners — Scarborough, Maine, United States
• Michigan Orthopedics Instititute — Southfield, Michigan, United States
• OrthoCarolina — Charlotte, North Carolina, United States
• Pacific Sports and Spine — Eugene, Oregon, United States
• Rothman Orthopedic Institute — Bensalem, Pennsylvania, United States
• Seton Spine and Scoliosis Center — Austin, Texas, United States
• Virginia iSpine Physicians — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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