Facet Versus Trigger Point Injections for Chronic Neck Pain

Condition(s) targeted: Chronic Mechanical (Myofascial) Neck Pain

Intervention: Betamethasone (Procedure); Dexamethasone (Procedure); Intramuscular Lidocaine (Procedure); Home Exercise (Behavioral)

Phase: Phase 2

Status: Recruiting

Sponsored by: Lawson Health Research Institute

Official(s) and/or principal investigator(s):
David M Walton, BScPT, PhD, Principal Investigator, Affiliation: Western University, Canada

Overall contact:
David M Walton, BScPT, PhD, Phone: +1-519-661-2111, Ext: 80145, Email: dwalton5@uwo.ca

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.

Official title: Facet Versus Trigger Point Injection for Management of Chronic Muscular Neck Pain: A Randomized Clinical Trial and Creation of a Clinical Prediction Algorithm

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

Primary outcome: Patient Global Impression of Change (PGIC)

Secondary outcome:

Pain Intensity Numeric Rating Scale

Neck Disability Index

Headache Impact Test - 6

Patient Health Questionnaire - 9

Adverse Events Checklist

Global Cervical Active Range of Motion

Mechanical (Pressure) Pain Threshold

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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.

David M Walton, BScPT, PhD, Phone: +1-519-661-2111, Ext: 80145, Email: dwalton5@uwo.ca

St. Joseph's Hospital / Parkwood Hospital, London, Ontario N6A 4V2, Canada; Recruiting
Eldon Loh, MD, Email: Eldon.Loh@sjhc.london.on.ca
Eldon Loh, MD, Sub-Investigator

Starting date: May 2013
Last updated: March 30, 2015