Intraarticular Lumbar Joint Corticosteroid Injection(s) as a Treatment of Chronic Low Back Pain in a Selected Population

University of Florida

Status and phase

Completed

Early Phase 1

Conditions

Low Back Pain

Treatments

Drug: Intra-articular corticosteroid injection

Drug: Intra-articular saline injection

Study type

Interventional

Funder types

Other

Identifiers

NCT01382771

319-2010

Details and patient eligibility

About

Subjects (N=120) who have had non-radicular low back pain, believed by clinical assessment and imaging to be consistent with lumbar zygapophysial joint (Z-joint) generated pain, who have failed conservative therapy including physical therapy, have had an initial >80% pain relief on a diagnostic medial branch block, and are scheduled to undergo a routine second medial branch block for facet mediated pain will be randomized. Both groups will receive the standard of care, a medial branch block. The treatment group will also receive one set of intra-articular lumbar Z-joint corticosteroid injection and the placebo group will receive intra-articular normal saline.

Full description

Subjects will have failed conservative treatment, including, but not limited to oral medications, physical therapy, chiropractic treatment, and/or alternative medicine. They will be evaluated by a spine specialist in the Spine Division of the Department of Orthopaedics and will be schedule for a medial branch block as standard of care. As part of usual and standard care, patients will undergo lumbar medial branch blocks for diagnosis of zygapophysial joint pain.

Patients who obtain ≥ to 80% relief of their index pain with a first set of lumbar medial branch blocks will be offered the opportunity for possible inclusion in the study if they are scheduled to receive a second medial branch block. The definition of a positive response to MBB's is an 80% reduction in pain (by change in NPR scores or estimated patient improvement) AND the restoration of the ability to perform at least one previously painful posture, movement, or activity without increase in pain, during the anesthetic phase of the blocks. If subjects are unable to render NPR scores or percentage estimate of improvement, then a 5 point global perception of effect tool will be used.

Enrollment

28 patients

Sex

All

Ages

45 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Low back pain episode greater than six months in duration
NPR pain scale score three day average and present pain of at least four/ten at baseline (index pain)
Previous medial branch block providing >80% pain relief for current painful episode
Subject must be scheduled to undergo a second medial branch block for their back pain

Exclusion criteria

Litigation
Those seeking new or increased long-term remuneration
Leg pain greater than back pain
Radicular pain or evidence of neurological compromise in the lower limbs
Those unable to read English and complete the assessment instruments
Systemic inflammatory arthritis (e.g. rheumatoid, lupus)
Addictive behavior, severe clinical depression or psychotic features. The subjects will be identified at the sole discretion of the PI who per the current standard of care will consent the potential subjects to the study
Significant lower extremity pathology that affects gait
Sustained cervical or thoracic pain that is present at a level >3/10 on NPR
Possible pregnancy or other reason that precludes the use of fluoroscopy
Significant scoliosis
Radicular/neurological deficits or focal disc herniation and/or stenosis, with correlating radicular symptoms
Contra-indication to corticosteroid, including known allergies or sensitivities
History of prior epidural spinal injections relieving their current pain, or prior lumbar surgery.