Facet Versus Trigger Point Injections for Chronic Neck Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Neck Pain
• Intervention / Treatment: Procedure: Dexamethasone; Procedure: Betamethasone; Procedure: Intramuscular Lidocaine; Behavioral: Home Exercise

• Study Type: Interventional
• Enrollment (Anticipated): 43
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 4V2
      • St. Joseph's Hospital / Parkwood Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexamethasone; Intra-articular corticosteroid number 2.	Procedure: Dexamethasone; 4mg/mL
Experimental: Betamethasone; Subjects will receive either betamethasone or dexamethasone injected into the cervical facet joints (levels determined by experienced physician).	Procedure: Betamethasone; 6 mg/mL injected into the facet joint as dictated by modified dual-comparative medial branch block diagnostic protocol; Other Names: Betaject/Celestone
Active Comparator: Intramuscular injection; Subjects in this group will receive lidocaine injection directly into tender myofascial trigger points.	Procedure: Intramuscular Lidocaine; 2%
Active Comparator: Home exercise; Subjects in this group will receive education and a pamphlet on a set of standardized home exercises for neck pain	Behavioral: Home Exercise; Standardized home exercise program

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: David M Walton, BScPT, PhD, Western University, Canada

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2013
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: March 7, 2013
• First Submitted That Met QC Criteria: March 8, 2013
• First Posted (Estimate): March 11, 2013

Study Record Updates

• Last Update Posted (Actual): December 17, 2018
• Last Update Submitted That Met QC Criteria: December 13, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: chronic pain; Neck; facet injection
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Anti-Asthmatic Agents; Respiratory System Agents; Dexamethasone; Lidocaine; Betamethasone
• Other Study ID Numbers: 2982

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No