Facet Versus Trigger Point Injections for Chronic Neck Pain

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2013 by Lawson Health Research Institute
Sponsor:
Information provided by (Responsible Party):
Dave Walton, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01808586
First received: March 7, 2013
Last updated: March 8, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Chronic Mechanical (Myofascial) Neck Pain
Procedure: Betamethasone
Procedure: Dexamethasone
Procedure: Intramuscular Lidocaine
Behavioral: Home Exercise
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Patient Global Impression of Change (PGIC) [ Time Frame: 1, 3, and 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1, 3, and 6 months ] [ Designated as safety issue: No ]
  • Neck Disability Index [ Time Frame: 1, 3, and 6 months ] [ Designated as safety issue: No ]
  • Headache Impact Test - 6 [ Time Frame: 1, 3, and 6 months ] [ Designated as safety issue: No ]
  • Patient Health Questionnaire - 9 [ Time Frame: 1, 3, and 6 months ] [ Designated as safety issue: No ]
  • Adverse Events Checklist [ Time Frame: 1, 3, and 6 months ] [ Designated as safety issue: Yes ]
    Constructed specifically for this study.

  • Global Cervical Active Range of Motion [ Time Frame: 1, 3, and 6 months ] [ Designated as safety issue: No ]
    Measured using a digital inclinometer

  • Mechanical (Pressure) Pain Threshold [ Time Frame: 1, 3, and 6 months ] [ Designated as safety issue: No ]
    Measured using a digital algometer over standardized myofascial trigger points.


Estimated Enrollment: 43
Study Start Date: May 2013
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexamethasone
Intra-articular corticosteroid number 2.
Procedure: Dexamethasone
4mg/mL
Experimental: Betamethasone
Subjects will receive either betamethasone or dexamethasone injected into the cervical facet joints (levels determined by experienced physician).
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
Active Comparator: Intramuscular injection
Subjects in this group will receive lidocaine injection directly into tender myofascial trigger points.
Procedure: Intramuscular Lidocaine
2%
Active Comparator: Home exercise
Subjects in this group will receive education and a pamphlet on a set of standardized home exercises for neck pain
Behavioral: Home Exercise
Standardized home exercise program

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01808586

Contacts
Contact: David M Walton, BScPT, PhD +1-519-661-2111 ext 80145 dwalton5@uwo.ca

Locations
Canada, Ontario
St. Joseph's Hospital / Parkwood Hospital Not yet recruiting
London, Ontario, Canada, N6A 4V2
Contact: Eldon Loh, MD       Eldon.Loh@sjhc.london.on.ca   
Sub-Investigator: Eldon Loh, MD         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: David M Walton, BScPT, PhD Western University, Canada
  More Information

No publications provided

Responsible Party: Dave Walton, Principle Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01808586     History of Changes
Other Study ID Numbers: 2982
Study First Received: March 7, 2013
Last Updated: March 8, 2013
Health Authority: Canada: Western University Health Sciences Research Ethics Board

Keywords provided by Lawson Health Research Institute:
Neck
chronic pain
facet injection

Additional relevant MeSH terms:
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dexamethasone acetate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Dexamethasone
Betamethasone
Betamethasone Valerate
Dexamethasone 21-phosphate
Betamethasone sodium phosphate
Lidocaine
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors

ClinicalTrials.gov processed this record on September 29, 2014