Facet Versus Trigger Point Injections for Chronic Neck Pain

Overview

A) Background Chronic neck pain is a significant and common issue which is difficult to treat. Tight bands of muscle (trigger points) can be a source of chronic neck pain and they are sometimes injected to manage chronic neck pain. However, these injections seldom lead to significant, long-lasting relief. In some cases, these trigger points may originate from injury or damage to a specific joint in the neck (the facet joint). Treatment of this joint with cortisone injection may lead to improved pain relief and function.

B) Hypothesis By injecting the facet joint with cortisone, the pain associated with tight bands of muscle in the neck and shoulders will be relieved to a greater extent than that attained through trigger point injection.

C) Methods Patients with neck pain will have a test to determine if any pain originates from the facet joint. Among those who have significant pain from these joints, a comparison between the effect of cortisone injection into these joints versus injection into the trigger points will be evaluated.

D) Expected Results and Significance

It is expected that injection with cortisone into the facet joints will lead to improved pain and function when compared to that attained from trigger point injection. In addition, the number of trigger points, and the pain and headache that originate from these trigger points, are expected to decrease with cortisone injection into the facets to a statistically and clinically significant extent. Results from this pilot study will then influence the design of future trials into chronic neck pain treatment, leading to better clinical recommendations. A peer-reviewed publication and conference presentations will facilitate dissemination.

Full Title of Study: “Facet Versus Trigger Point Injection for Management of Chronic Muscular Neck Pain: A Randomized Clinical Trial and Creation of a Clinical Prediction Algorithm”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: December 2016

Interventions

  • Procedure: Betamethasone
    • 6 mg/mL injected into the facet joint as dictated by modified dual-comparative medial branch block diagnostic protocol
  • Procedure: Dexamethasone
    • 4mg/mL
  • Procedure: Intramuscular Lidocaine
    • 2%
  • Behavioral: Home Exercise
    • Standardized home exercise program

Arms, Groups and Cohorts

  • Experimental: Dexamethasone
    • Intra-articular corticosteroid number 2.
  • Experimental: Betamethasone
    • Subjects will receive either betamethasone or dexamethasone injected into the cervical facet joints (levels determined by experienced physician).
  • Active Comparator: Intramuscular injection
    • Subjects in this group will receive lidocaine injection directly into tender myofascial trigger points.
  • Active Comparator: Home exercise
    • Subjects in this group will receive education and a pamphlet on a set of standardized home exercises for neck pain

Clinical Trial Outcome Measures

Primary Measures

  • Patient Global Impression of Change (PGIC)
    • Time Frame: 1, 3, and 6 months
    • A 15-point self-report scale ranging from 0 = A very great deal worse to 15 = A very great deal better (8 = no change).

Secondary Measures

  • Pain Intensity Numeric Rating Scale
    • Time Frame: 1, 3, and 6 months
  • Neck Disability Index
    • Time Frame: 1, 3, and 6 months
  • Headache Impact Test – 6
    • Time Frame: 1, 3, and 6 months
  • Patient Health Questionnaire – 9
    • Time Frame: 1, 3, and 6 months
  • Adverse Events Checklist
    • Time Frame: 1, 3, and 6 months
    • Constructed specifically for this study.
  • Global Cervical Active Range of Motion
    • Time Frame: 1, 3, and 6 months
    • Measured using a digital inclinometer
  • Mechanical (Pressure) Pain Threshold
    • Time Frame: 1, 3, and 6 months
    • Measured using a digital algometer over standardized myofascial trigger points.

Participating in This Clinical Trial

Inclusion Criteria

  • between 18 and 65 years of age and able to speak and understand conversational English
  • Primary diagnosis of chronic (>6 months) mechanical / myofascial neck pain

Exclusion Criteria

  • Those with significant cognitive decline or cognitive interference (as identified by the physician) will be excluded, as will those who have received radiofrequency ablation of any cervical nerve within the past year, intra-articular cortisone facet injection within the past 4 months, trigger point injection into the cervical/shoulder girdle muscles within the past 4 months, or the presence of any known contraindication to injection (Attachments).
  • Women who are or may be pregnant (based on last menstruation) will be excluded.
  • Finally, for the purposes of this pilot study, those currently involved in active litigation regarding the neck pain will be excluded. Those with active worker's compensation claims or currently receiving salary indemnity benefits through motor vehicle insurance providers will be included, as they represent a significant proportion of this population.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Lawson Health Research Institute
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dave Walton, Principle Investigator – Lawson Health Research Institute
  • Overall Official(s)
    • David M Walton, BScPT, PhD, Principal Investigator, Western University, Canada

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