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

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01382771
• Other study ID #: 319-2010
• Status: Completed
• Phase: Phase 0
• First received: June 23, 2011
• Last updated: October 10, 2013
• Start date: October 2010
• Est. completion date: September 2012

Study information

• Verified date: October 2013
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Drug:
• Intra-articular corticosteroid injection
Intra-articular injection of 0.5 cc triamcinolone acetonide (40 mg/cc) within each joint
• Intra-articular saline injection
Intra-articular injection of 0.5 cc normal saline in each joint

Locations

Country	Name	City	State
United States	UF & Shands Orthopaedics and Sports Medicine Institute	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Hourly for 6 hours post injections	No
Secondary	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.	reviewed at 6 weeks, 3 months, 6 months, 12 months follow-up	No
Secondary	Oswestry Disability Index (ODI)	Patient will complete ODI at the follow-up intervals.	6 weeks, 3 months, 6 months, 12 months	No
Secondary	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.	6 weeks, 3 months, 6 months, 12 months	No
Secondary	Daily Work History Log	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	No
Secondary	Daily Analgesic Use Log	Patient will keep a Daily Analgesic Use Log during participation.	reviewed at 6 weeks, 3 months, 6 months, 12 months	No
Secondary	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.	reviewed at 6 weeks, 3 months, 6 months, 12 months follow-up	No