Facet Versus Trigger Point Injections for Chronic Neck Pain

Neck Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01808586
• Other study ID #: 2982
• Status: Completed
• Phase: Phase 2
• Start date: May 2013
• Est. completion date: December 2016

Study information

• Verified date: December 2018
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neck Pain

Intervention

Procedure:
• Betamethasone
6 mg/mL injected into the facet joint as dictated by modified dual-comparative medial branch block diagnostic protocol
• Dexamethasone
4mg/mL
• Intramuscular Lidocaine
2%

Behavioral:
• Home Exercise
Standardized home exercise program

Locations

Country	Name	City	State
Canada	St. Joseph's Hospital / Parkwood Hospital	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

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