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OpenTrials
Completed

NCT Number: NCT01808586

Facet Versus Trigger Point Injections for Chronic Neck Pain

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St. Joseph's Hospital / Parkwood Hospital

London, Ontario, N6A 4V2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Betamethasone

Procedure

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

Other names: Betaject/Celestone

Dexamethasone

Procedure

4mg/mL

Intramuscular Lidocaine

Procedure

2%

Home exercise

Behavioral

Standardized home exercise program

Primary outcomes

  1. 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 outcomes

  1. Pain Intensity Numeric Rating Scale

    Time frame: 1, 3, and 6 months

  2. Neck Disability Index

    Time frame: 1, 3, and 6 months

  3. Headache Impact Test - 6

    Time frame: 1, 3, and 6 months

  4. Patient Health Questionnaire - 9

    Time frame: 1, 3, and 6 months

  5. Adverse Events Checklist

    Time frame: 1, 3, and 6 months

    Constructed specifically for this study.

  6. Global Cervical Active Range of Motion

    Time frame: 1, 3, and 6 months

    Measured using a digital inclinometer

  7. Mechanical (Pressure) Pain Threshold

    Time frame: 1, 3, and 6 months

    Measured using a digital algometer over standardized myofascial trigger points.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Mar 11, 2013
Registry last updated
Dec 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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