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Facet Versus Trigger Point Injections for Chronic Neck Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01808586
Recruitment Status : Completed
First Posted : March 11, 2013
Last Update Posted : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
Dave Walton, Lawson Health Research Institute

Tracking Information
First Submitted Date  ICMJE March 7, 2013
First Posted Date  ICMJE March 11, 2013
Last Update Posted Date December 17, 2018
Actual Study Start Date  ICMJE May 2013
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2013)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2013)
  • Pain Intensity Numeric Rating Scale [ Time Frame: 1, 3, and 6 months ]
  • Neck Disability Index [ Time Frame: 1, 3, and 6 months ]
  • Headache Impact Test - 6 [ Time Frame: 1, 3, and 6 months ]
  • Patient Health Questionnaire - 9 [ Time Frame: 1, 3, and 6 months ]
  • Adverse Events Checklist [ Time Frame: 1, 3, and 6 months ]
    Constructed specifically for this study.
  • Global Cervical Active Range of Motion [ Time Frame: 1, 3, and 6 months ]
    Measured using a digital inclinometer
  • Mechanical (Pressure) Pain Threshold [ Time Frame: 1, 3, and 6 months ]
    Measured using a digital algometer over standardized myofascial trigger points.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Facet Versus Trigger Point Injections for Chronic Neck Pain
Official Title  ICMJE Facet Versus Trigger Point Injection for Management of Chronic Muscular Neck Pain: A Randomized Clinical Trial and Creation of a Clinical Prediction Algorithm
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Neck Pain
Intervention  ICMJE
  • Procedure: Betamethasone
    6 mg/mL injected into the facet joint as dictated by modified dual-comparative medial branch block diagnostic protocol
    Other Name: Betaject/Celestone
  • Procedure: Dexamethasone
    4mg/mL
  • Procedure: Intramuscular Lidocaine
    2%
  • Behavioral: Home Exercise
    Standardized home exercise program
Study Arms  ICMJE
  • Experimental: Dexamethasone
    Intra-articular corticosteroid number 2.
    Intervention: Procedure: Dexamethasone
  • Experimental: Betamethasone
    Subjects will receive either betamethasone or dexamethasone injected into the cervical facet joints (levels determined by experienced physician).
    Intervention: Procedure: Betamethasone
  • Active Comparator: Intramuscular injection
    Subjects in this group will receive lidocaine injection directly into tender myofascial trigger points.
    Intervention: Procedure: Intramuscular Lidocaine
  • Active Comparator: Home exercise
    Subjects in this group will receive education and a pamphlet on a set of standardized home exercises for neck pain
    Intervention: Behavioral: Home Exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: March 8, 2013)
43
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01808586
Other Study ID Numbers  ICMJE 2982
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Dave Walton, Lawson Health Research Institute
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Lawson Health Research Institute
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David M Walton, BScPT, PhD Western University, Canada
PRS Account Lawson Health Research Institute
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP