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

Early Phase 1

Completed

• Conditions: Low Back Pain
• Interventions: Drug: Intra-articular saline injection; Drug: Intra-articular corticosteroid injection

• Registration Number: NCT01382771
• Lead Sponsor: University of Florida

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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2011-06-23
• Study First Submitted QC: 2011-06-24
• Study First Posted: 2011-06-27
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-10
• Last Update Posted: 2013-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intra-articular saline injection	Intra-articular saline injection	Intra-articular saline injections with confirmatory anesthetic medial branch blocks
Intra-articular corticosteroid injection	Intra-articular corticosteroid injection	Intra-articular corticosteroid injection in conjunction with confirmatory anesthetic medial branch blocks

Primary Outcome Measures

Name	Time	Method
Numeric Pain Rating (NPR) or patient estimation of improvement, >80% pain reduction	Hourly for 6 hours post injections	A positive response is defined as are ≥ 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.

Secondary Outcome Measures

Name	Time	Method
Oswestry Disability Index (ODI)	6 weeks, 3 months, 6 months, 12 months	Patient will complete ODI at the follow-up intervals.
Daily Work History Log	reviewed at the 6 weeks, 3months, 6 months, 12 months follow-up	Patient will keep a Work History Log during participation. The Log should indicate the daily work activities of the subject.
Numeric Pain Rating (NPR) Daily diary	reviewed at 6 weeks, 3 months, 6 months, 12 months follow-up	The patient will be instructed to maintain a pain diary that records the degree and duration of any relief.
Daily Analgesic Use Log	reviewed at 6 weeks, 3 months, 6 months, 12 months	Patient will keep a Daily Analgesic Use Log during participation.
Standard Form 36 (SF-36), General Health Survey	6 weeks, 3 months, 6 months, 12 months	Patient will complete the SF-36 at the follow-up intervals. The SF-36 is a self-administered, generic, general health survey consisting of 36 questions. The questions focus on the functional health and well being of the subject completing the form.
Ancillary Treatment Log	reviewed at 6 weeks, 3 months, 6 months, 12 months follow-up	Patient will keep an Ancillary Treatment Log during participation. This log will indicate any outside medical care, additional medial branch blocks or radiofrequency neurotomy treatments.

Trial Locations

Locations (1)

UF & Shands Orthopaedics and Sports Medicine Institute; 🇺🇸 Gainesville, Florida, United States