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临床试验/NCT01808586
NCT01808586已完成2 期

Facet Versus Trigger Point Injection for Management of Chronic Muscular Neck Pain: A Randomized Clinical Trial and Creation of a Clinical Prediction Algorithm

Lawson Health Research Institute2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2013年5月最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
43
试验地点
2
主要终点
Patient Global Impression of Change (PGIC)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

Intramuscular injection

Active Comparator

Subjects in this group will receive lidocaine injection directly into tender myofascial trigger points.

干预措施: Intramuscular Lidocaine (Procedure)

Home exercise

Active Comparator

Subjects in this group will receive education and a pamphlet on a set of standardized home exercises for neck pain

干预措施: Home Exercise (Behavioral)

Dexamethasone

Experimental

Intra-articular corticosteroid number 2.

干预措施: Dexamethasone (Procedure)

Betamethasone

Experimental

Subjects will receive either betamethasone or dexamethasone injected into the cervical facet joints (levels determined by experienced physician).

干预措施: Betamethasone (Procedure)

结局指标

主要结局

Patient Global Impression of Change (PGIC)

时间窗: 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).

次要结局

  • Headache Impact Test - 6(1, 3, and 6 months)
  • Patient Health Questionnaire - 9(1, 3, and 6 months)
  • Pain Intensity Numeric Rating Scale(1, 3, and 6 months)
  • Neck Disability Index(1, 3, and 6 months)
  • Adverse Events Checklist(1, 3, and 6 months)
  • Global Cervical Active Range of Motion(1, 3, and 6 months)
  • Mechanical (Pressure) Pain Threshold(1, 3, and 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dave Walton

Principle Investigator

Lawson Health Research Institute

研究点 (2)

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