Facet Versus Trigger Point Injections for Chronic Neck Pain

NCT01808586 | Completed Phase 2

• 1 other identifier: 2982
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neck Pain

Keywords

Neck; chronic pain; facet injection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

  1, 3, and 6 months

Study Arms (4)

Dexamethasone

EXPERIMENTAL

Intra-articular corticosteroid number 2.

Procedure: Dexamethasone

Betamethasone

EXPERIMENTAL

Subjects will receive either betamethasone or dexamethasone injected into the cervical facet joints (levels determined by experienced physician).

Procedure: Betamethasone

Intramuscular injection

ACTIVE COMPARATOR

Subjects in this group will receive lidocaine injection directly into tender myofascial trigger points.

Procedure: Intramuscular Lidocaine

Home exercise

ACTIVE COMPARATOR

Subjects in this group will receive education and a pamphlet on a set of standardized home exercises for neck pain

Behavioral: Home Exercise

Interventions

Betamethasone PROCEDURE

6 mg/mL injected into the facet joint as dictated by modified dual-comparative medial branch block diagnostic protocol

Also known as: Betaject/Celestone

Betamethasone

Dexamethasone PROCEDURE

4mg/mL

Dexamethasone

Intramuscular Lidocaine PROCEDURE

2%

Intramuscular injection

Home Exercise BEHAVIORAL

Standardized home exercise program

Home exercise

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

St. Joseph's Hospital / Parkwood Hospital

London, Ontario, N6A 4V2, Canada

Location

MeSH Terms

Conditions

Neck Pain; Chronic Pain

Interventions

Betamethasone; Dexamethasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• David M Walton, BScPT, PhD

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 7, 2013
• First Posted: March 11, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 17, 2018

Record last verified: 2018-12

Locations

CA (1)