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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01808586|
Recruitment Status : Recruiting
First Posted : March 11, 2013
Last Update Posted : March 3, 2016
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||43 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
Intra-articular corticosteroid number 2.
Subjects will receive either betamethasone or dexamethasone injected into the cervical facet joints (levels determined by experienced physician).
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
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
- 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).
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01808586
|Contact: David M Walton, BScPT, PhD||+1-519-661-2111 ext firstname.lastname@example.org|
|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|
|Principal Investigator:||David M Walton, BScPT, PhD||Western University, Canada|