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Facet Versus Trigger Point Injections for Chronic Neck Pain

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ClinicalTrials.gov Identifier: NCT01808586
Recruitment Status : Recruiting
First Posted : March 11, 2013
Last Update Posted : March 3, 2016
Sponsor:
Information provided by (Responsible Party):

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.


Condition or disease Intervention/treatment Phase
Neck Pain Procedure: Betamethasone Procedure: Dexamethasone Procedure: Intramuscular Lidocaine Behavioral: Home Exercise Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : May 2013
Estimated Primary Completion Date : December 2016


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Pain Intensity Numeric Rating Scale [ Time Frame: 1, 3, and 6 months ]
  2. Neck Disability Index [ Time Frame: 1, 3, and 6 months ]
  3. Headache Impact Test - 6 [ Time Frame: 1, 3, and 6 months ]
  4. Patient Health Questionnaire - 9 [ Time Frame: 1, 3, and 6 months ]
  5. Adverse Events Checklist [ Time Frame: 1, 3, and 6 months ]
    Constructed specifically for this study.

  6. Global Cervical Active Range of Motion [ Time Frame: 1, 3, and 6 months ]
    Measured using a digital inclinometer

  7. Mechanical (Pressure) Pain Threshold [ Time Frame: 1, 3, and 6 months ]
    Measured using a digital algometer over standardized myofascial trigger points.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 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

Responsible Party: Dave Walton, Principle Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01808586     History of Changes
Other Study ID Numbers: 2982
First Posted: March 11, 2013    Key Record Dates
Last Update Posted: March 3, 2016
Last Verified: March 2016

Keywords provided by Dave Walton, 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 benzoate
Betamethasone-17,21-dipropionate
Dexamethasone
Betamethasone
Betamethasone Valerate
Betamethasone sodium phosphate
Lidocaine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics