Clinical trial NCT01808586: Facet Versus Trigger Point Injections for Chronic Neck Pain
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neck Pain
Keywords: Neck
chronic pain
facet injection
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2013-03-11
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Patient Global Impression of Change (PGIC)
timeFrame: 1, 3, and 6 months
Secondary outcomes:
measure: Pain Intensity Numeric Rating Scale
timeFrame: 1, 3, and 6 months
measure: Neck Disability Index
timeFrame: 1, 3, and 6 months
measure: Headache Impact Test - 6
timeFrame: 1, 3, and 6 months
measure: Patient Health Questionnaire - 9
timeFrame: 1, 3, and 6 months
measure: Adverse Events Checklist
timeFrame: 1, 3, and 6 months
measure: Global Cervical Active Range of Motion
timeFrame: 1, 3, and 6 months
measure: Mechanical (Pressure) Pain Threshold
timeFrame: 1, 3, and 6 months
Other outcomes:
Locations:
city: London
country: Canada
facility: St. Joseph's Hospital / Parkwood Hospital
state: Ontario
Study officials:
affiliation: Western University, Canada
name: David M Walton, BScPT, PhD
role: PRINCIPAL_INVESTIGATOR
References: