Back to resultsIntraarticular Lumbar Joint Corticosteroid Injection(s) as a Treatment of Chronic Low Back Pain in a Selected Population
Primary Purpose
Low Back Pain
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Intra-articular corticosteroid injection
Intra-articular saline injection
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring low back pain, zygapophysial joint pain, medial branch block, > 6 months duration, non-radicular
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.
Sites / Locations
- UF & Shands Orthopaedics and Sports Medicine Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Intra-articular corticosteroid injection
Intra-articular saline injection
Arm Description
Intra-articular corticosteroid injection in conjunction with confirmatory anesthetic medial branch blocks
Intra-articular saline injections with confirmatory anesthetic medial branch blocks
Outcomes
Primary Outcome Measures
Numeric Pain Rating (NPR) or patient estimation of improvement, >80% pain reduction
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
Numeric Pain Rating (NPR) Daily diary
The patient will be instructed to maintain a pain diary that records the degree and duration of any relief.
Oswestry Disability Index (ODI)
Patient will complete ODI at the follow-up intervals.
Standard Form 36 (SF-36), General Health Survey
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.
Daily Work History Log
Patient will keep a Work History Log during participation. The Log should indicate the daily work activities of the subject.
Daily Analgesic Use Log
Patient will keep a Daily Analgesic Use Log during participation.
Ancillary Treatment Log
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01382771
Brief Title
Intraarticular Lumbar Joint Corticosteroid Injection(s) as a Treatment of Chronic Low Back Pain in a Selected Population
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
low back pain, zygapophysial joint pain, medial branch block, > 6 months duration, non-radicular
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intra-articular corticosteroid injection
Arm Type
Active Comparator
Arm Description
Intra-articular corticosteroid injection in conjunction with confirmatory anesthetic medial branch blocks
Arm Title
Intra-articular saline injection
Arm Type
Placebo Comparator
Arm Description
Intra-articular saline injections with confirmatory anesthetic medial branch blocks
Intervention Type
Drug
Intervention Name(s)
Intra-articular corticosteroid injection
Intervention Description
Intra-articular injection of 0.5 cc triamcinolone acetonide (40 mg/cc) within each joint
Intervention Type
Drug
Intervention Name(s)
Intra-articular saline injection
Intervention Description
Intra-articular injection of 0.5 cc normal saline in each joint
Primary Outcome Measure Information:
Title
Numeric Pain Rating (NPR) or patient estimation of improvement, >80% pain reduction
Description
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.
Time Frame
Hourly for 6 hours post injections
Secondary Outcome Measure Information:
Title
Numeric Pain Rating (NPR) Daily diary
Description
The patient will be instructed to maintain a pain diary that records the degree and duration of any relief.
Time Frame
reviewed at 6 weeks, 3 months, 6 months, 12 months follow-up
Title
Oswestry Disability Index (ODI)
Description
Patient will complete ODI at the follow-up intervals.
Time Frame
6 weeks, 3 months, 6 months, 12 months
Title
Standard Form 36 (SF-36), General Health Survey
Description
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.
Time Frame
6 weeks, 3 months, 6 months, 12 months
Title
Daily Work History Log
Description
Patient will keep a Work History Log during participation. The Log should indicate the daily work activities of the subject.
Time Frame
reviewed at the 6 weeks, 3months, 6 months, 12 months follow-up
Title
Daily Analgesic Use Log
Description
Patient will keep a Daily Analgesic Use Log during participation.
Time Frame
reviewed at 6 weeks, 3 months, 6 months, 12 months
Title
Ancillary Treatment Log
Description
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.
Time Frame
reviewed at 6 weeks, 3 months, 6 months, 12 months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
D. J. Kennedy, M.D.
Organizational Affiliation
UF Department of Orthopaedics and Rehabilitation
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF & Shands Orthopaedics and Sports Medicine Institute
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
12. IPD Sharing Statement
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Intraarticular Lumbar Joint Corticosteroid Injection(s) as a Treatment of Chronic Low Back Pain in a Selected Population
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