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

NCT01382771 | Completed Early Phase 1

• 1 other identifier: 319-2010
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Numeric Pain Rating (NPR) Daily diary

  reviewed at 6 weeks, 3 months, 6 months, 12 months follow-up

• Oswestry Disability Index (ODI)

  6 weeks, 3 months, 6 months, 12 months

• Standard Form 36 (SF-36), General Health Survey

  6 weeks, 3 months, 6 months, 12 months

• Daily Work History Log

  reviewed at the 6 weeks, 3months, 6 months, 12 months follow-up

• Daily Analgesic Use Log

  reviewed at 6 weeks, 3 months, 6 months, 12 months

Study Arms (2)

Intra-articular corticosteroid injection

ACTIVE COMPARATOR

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

Drug: Intra-articular corticosteroid injection

Intra-articular saline injection

PLACEBO COMPARATOR

Intra-articular saline injections with confirmatory anesthetic medial branch blocks

Drug: Intra-articular saline injection

Interventions

Intra-articular corticosteroid injection DRUG

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

Intra-articular corticosteroid injection

Intra-articular saline injection DRUG

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

Intra-articular saline injection

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF & Shands Orthopaedics and Sports Medicine Institute

Gainesville, Florida, 32607, United States

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Adrenal Cortex Hormones; Sodium Chloride

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• D. J. Kennedy, M.D.

  UF Department of Orthopaedics and Rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2011
• First Posted: June 27, 2011
• Study Start: October 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: October 14, 2013

Record last verified: 2013-10

Locations

US (1)