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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01808586
Enrollment
43
Registered
2013-03-11
Start date
2013-05-31
Completion date
2016-12-31
Last updated
2018-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neck Pain

Keywords

Neck, chronic pain, facet injection

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.

Interventions

PROCEDUREBetamethasone

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

PROCEDUREDexamethasone

4mg/mL

PROCEDUREIntramuscular Lidocaine

2%

BEHAVIORALHome Exercise

Standardized home exercise program

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Neck Disability Index1, 3, and 6 months
Headache Impact Test - 61, 3, and 6 months
Patient Health Questionnaire - 91, 3, and 6 months
Pain Intensity Numeric Rating Scale1, 3, and 6 months
Global Cervical Active Range of Motion1, 3, and 6 monthsMeasured using a digital inclinometer
Mechanical (Pressure) Pain Threshold1, 3, and 6 monthsMeasured using a digital algometer over standardized myofascial trigger points.
Adverse Events Checklist1, 3, and 6 monthsConstructed specifically for this study.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026