Facet Versus Trigger Point Injections for Chronic Neck Pain
Primary Purpose
Neck Pain
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Betamethasone
Dexamethasone
Intramuscular Lidocaine
Home Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain focused on measuring Neck, chronic pain, facet injection
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.
Sites / Locations
- St. Joseph's Hospital / Parkwood Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Active Comparator
Arm Label
Dexamethasone
Betamethasone
Intramuscular injection
Home exercise
Arm Description
Intra-articular corticosteroid number 2.
Subjects will receive either betamethasone or dexamethasone injected into the cervical facet joints (levels determined by experienced physician).
Subjects in this group will receive lidocaine injection directly into tender myofascial trigger points.
Subjects in this group will receive education and a pamphlet on a set of standardized home exercises for neck pain
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Pain Intensity Numeric Rating Scale
Neck Disability Index
Headache Impact Test - 6
Patient Health Questionnaire - 9
Adverse Events Checklist
Constructed specifically for this study.
Global Cervical Active Range of Motion
Measured using a digital inclinometer
Mechanical (Pressure) Pain Threshold
Measured using a digital algometer over standardized myofascial trigger points.
Full Information
NCT ID
NCT01808586
First Posted
March 7, 2013
Last Updated
December 13, 2018
Sponsor
Lawson Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01808586
Brief Title
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
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
May 2013 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Neck, chronic pain, facet injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
43 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone
Arm Type
Experimental
Arm Description
Intra-articular corticosteroid number 2.
Arm Title
Betamethasone
Arm Type
Experimental
Arm Description
Subjects will receive either betamethasone or dexamethasone injected into the cervical facet joints (levels determined by experienced physician).
Arm Title
Intramuscular injection
Arm Type
Active Comparator
Arm Description
Subjects in this group will receive lidocaine injection directly into tender myofascial trigger points.
Arm Title
Home exercise
Arm Type
Active Comparator
Arm Description
Subjects in this group will receive education and a pamphlet on a set of standardized home exercises for neck pain
Intervention Type
Procedure
Intervention Name(s)
Betamethasone
Other Intervention Name(s)
Betaject/Celestone
Intervention Description
6 mg/mL injected into the facet joint as dictated by modified dual-comparative medial branch block diagnostic protocol
Intervention Type
Procedure
Intervention Name(s)
Dexamethasone
Intervention Description
4mg/mL
Intervention Type
Procedure
Intervention Name(s)
Intramuscular Lidocaine
Intervention Description
2%
Intervention Type
Behavioral
Intervention Name(s)
Home Exercise
Intervention Description
Standardized home exercise program
Primary Outcome Measure Information:
Title
Patient Global Impression of Change (PGIC)
Description
A 15-point self-report scale ranging from 0 = A very great deal worse to 15 = A very great deal better (8 = no change).
Time Frame
1, 3, and 6 months
Secondary Outcome Measure Information:
Title
Pain Intensity Numeric Rating Scale
Time Frame
1, 3, and 6 months
Title
Neck Disability Index
Time Frame
1, 3, and 6 months
Title
Headache Impact Test - 6
Time Frame
1, 3, and 6 months
Title
Patient Health Questionnaire - 9
Time Frame
1, 3, and 6 months
Title
Adverse Events Checklist
Description
Constructed specifically for this study.
Time Frame
1, 3, and 6 months
Title
Global Cervical Active Range of Motion
Description
Measured using a digital inclinometer
Time Frame
1, 3, and 6 months
Title
Mechanical (Pressure) Pain Threshold
Description
Measured using a digital algometer over standardized myofascial trigger points.
Time Frame
1, 3, and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M Walton, BScPT, PhD
Organizational Affiliation
Western University, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Hospital / Parkwood Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
12. IPD Sharing Statement
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Facet Versus Trigger Point Injections for Chronic Neck Pain
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