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

NCT ID: NCT01382771

Last Updated: 2013-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-09-30

Brief Summary

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.

Detailed 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.

Conditions

Low Back Pain

Keywords

low back pain; zygapophysial joint pain; medial branch block; > 6 months duration; non-radicular

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intra-articular corticosteroid injection

Intra-articular corticosteroid injection in conjunction with confirmatory anesthetic medial branch blocks

Group Type: ACTIVE_COMPARATOR

Intra-articular corticosteroid injection

Intervention Type: DRUG

Intra-articular injection of 0.5 cc triamcinolone acetonide (40 mg/cc) within each joint

Intra-articular saline injection

Intra-articular saline injections with confirmatory anesthetic medial branch blocks

Group Type: PLACEBO_COMPARATOR

Intra-articular saline injection

Intervention Type: DRUG

Intra-articular injection of 0.5 cc normal saline in each joint

Interventions

Intra-articular corticosteroid injection

Intra-articular injection of 0.5 cc triamcinolone acetonide (40 mg/cc) within each joint

Intervention Type: DRUG

Intra-articular saline injection

Intra-articular injection of 0.5 cc normal saline in each joint

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

D. J. Kennedy, M.D.

Role: PRINCIPAL_INVESTIGATOR

UF Department of Orthopaedics and Rehabilitation

Locations

UF & Shands Orthopaedics and Sports Medicine Institute

Gainesville, Florida, United States

Countries

United States

Other Identifiers

319-2010

Identifier Type: -

Identifier Source: org_study_id