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

October 10, 2013 updated by: University of Florida

A Randomized, Double-Blind, Placebo Controlled Perspective Study of Intraarticular Lumbar Zygapophysial Joint Corticosteroid Injection(s) as a Treatment of Chronic Low Back Pain in a Selected Population

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

28

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Gainesville, Florida, United States, 32607
        • UF & Shands Orthopaedics and Sports Medicine Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intra-articular corticosteroid injection
Intra-articular corticosteroid injection in conjunction with confirmatory anesthetic medial branch blocks
Intra-articular injection of 0.5 cc triamcinolone acetonide (40 mg/cc) within each joint
Placebo Comparator: Intra-articular saline injection
Intra-articular saline injections with confirmatory anesthetic medial branch blocks
Intra-articular injection of 0.5 cc normal saline in each joint

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Pain Rating (NPR) or patient estimation of improvement, >80% pain reduction
Time Frame: 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.
Hourly for 6 hours post injections

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Pain Rating (NPR) Daily diary
Time Frame: 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.
reviewed at 6 weeks, 3 months, 6 months, 12 months follow-up
Oswestry Disability Index (ODI)
Time Frame: 6 weeks, 3 months, 6 months, 12 months
Patient will complete ODI at the follow-up intervals.
6 weeks, 3 months, 6 months, 12 months
Standard Form 36 (SF-36), General Health Survey
Time Frame: 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.
6 weeks, 3 months, 6 months, 12 months
Daily Work History Log
Time Frame: 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.
reviewed at the 6 weeks, 3months, 6 months, 12 months follow-up
Daily Analgesic Use Log
Time Frame: reviewed at 6 weeks, 3 months, 6 months, 12 months
Patient will keep a Daily Analgesic Use Log during participation.
reviewed at 6 weeks, 3 months, 6 months, 12 months
Ancillary Treatment Log
Time Frame: 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.
reviewed at 6 weeks, 3 months, 6 months, 12 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: D. J. Kennedy, M.D., UF Department of Orthopaedics and Rehabilitation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

June 23, 2011

First Submitted That Met QC Criteria

June 24, 2011

First Posted (Estimate)

June 27, 2011

Study Record Updates

Last Update Posted (Estimate)

October 14, 2013

Last Update Submitted That Met QC Criteria

October 10, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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