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临床试验/NCT04278833
NCT04278833终止4 期

Comparative Effectiveness of Particulate Versus Nonparticulate Corticosteroid Injections for the Treatment of Musculoskeletal Conditions

Stanford University1 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2020年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
165
试验地点
1
主要终点
Mean Change in Average Pain From Baseline

研究概览

简要总结

This aims of this study are:

  1. To determine if particulate or non-particulate corticosteroid injections are more effective at treating pain from musculoskeletal pathologies of the hip, glenohumeral joint, biceps tendon, or subacromial/subdeltoid bursa at 2 weeks, 3 months, or 6 months.
  2. To determine if there is a significantly different side effect profile between particulate and non-particulate corticosteroids when used for hip, glenohumeral joint, biceps tendon, or subacromial/subdeltoid bursa injections.

详细描述

This will be a single center, prospective, single blind, randomized controlled trial of hip, glenohumeral joint, peri-tendinous biceps brachii, and subacromial/subdeltoid bursa injections comparing the efficacy of particulate (triamcinolone, betamethasone) versus non-particulate (dexamethasone) corticosteroids.

Participants will be recruited for the study by trained physicians and physician extenders at Stanford orthopedic and PM&R clinics only after they have already opted for corticosteroid injection as a part of their routine medical care. The initial decision to pursue steroid injection will be based entirely on joint decision making between the patient and their medical provider prior to mention of the study.

After consenting, basic demographic data, average numeric pain score (NRS) over the past week, and information on other medical interventions tried for their pain (including medication use, physical therapy, chiropractic care, and massage) will be collected. The participant will then be randomized to receive either a particulate (triamcinolone or betamethasone) or non-particulate (dexamethasone) corticosteroid, both of which are within current standards of care. Ultrasound or fluoroscopic guided injection will then be completed using sterile technique as per current clinic practice.

After the injection, patients will follow up in clinic or over the phone at 2 weeks, 3 months, and 6 months and will be asked their average NRS over the past week, functional questionnaires appropriate to pertinent body parts (WOMAC, ASES, QDASH), other treatments they have tried in the interim, and for any side effects they have experienced. In addition to obtaining outcome measures, the treating physicians may order repeat injections, medications, or refer the subject to surgery, at their discretion based upon the patient's pain and functional limitations. Up to a total of three injections to the same musculoskeletal structure are allowed during the 6 month study period. Any injection into a separate space (i.e. glenohumeral joint followed by subdeltoid bursa) will be considered different structures, and follow up for the new anatomical site will begin at the time of that injection. Data collection and follow up on the previous anatomical injection site will continue on the same timeline. Data on number and timing of repeat injections, surgeries, side effects, and medications will be recorded as part of the study.

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
Single (Participant)

盲法说明

Participants will be blinded to the type of corticosteroid (particulate or non-particulate) that they receive.

入排标准

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

入选标准

  • Age greater than or equal to 18
  • Ability to provide informed consent
  • Capable of complying with the outcome instruments used
  • Capable of attending all planned follow up visits
  • Patient is deemed appropriate for intra-articular hip, glenohumeral, peri-tendinous biceps, or subdeltoid bursa corticosteroid injection by their treating physician for the treatment of painful musculoskeletal condition
  • Average pain of greater than or equal to 4/10 over the last 7 days

排除标准

  • Unclear diagnosis
  • Pregnancy
  • Incarcerated patients
  • Prior corticosteroid injection into the same anatomical site within the last 3 months
  • Prior prosthetic surgery on the joint
  • Any condition that increases injection risk such as bleeding tendencies, uncontrolled diabetes, current active infection, or infection requiring antibiotics within the last 7 days
  • Chronic opioid use to control pain
  • Workers compensation and litigation
  • BMI > 40

研究组 & 干预措施

Particulate Corticosteroid Injection

Other

Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 10-80mg of triamcinolone or 3-9mg of betamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion.

干预措施: Triamcinolone or Betamethasone (Drug)

Non-particulate Corticosteroid Injection

Other

Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 4-10mg of dexamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion.

干预措施: Dexamethasone (Drug)

结局指标

主要结局

Mean Change in Average Pain From Baseline

时间窗: Baseline and at 2 weeks, 3 months, and 6 months post intervention

Mean change in pain averaged over last 7 days compared to baseline as rated on 11 point numerical rating scale (NRS, score range from 0-10) with higher values indicating worse outcomes.

Number of Participants With ≥50% Decrease in Pain From Baseline

时间窗: Baseline and at 2 weeks, 3 months, and 6 months post intervention

Decrease in pain compared to baseline as rated on 11 point numerical rating scale (NRS, score range from 0-10) with higher values indicating worse outcomes.

次要结局

  • Change in Quick Disabilities of Arm, Shoulder, and Hand (QDASH)(Baseline and at 2 weeks, 3 months, and 6 months post intervention)
  • Number of Participants With Repeat Corticosteroid Injections(6 months post initial intervention)
  • Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index(Baseline and at 2 weeks, 3 months, and 6 months post intervention)
  • Change in American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment Form(Baseline and at 2 weeks, 3 months, and 6 months post intervention)
  • Number of Participants Referred for Surgical Intervention (Conversion to Surgery)(6 months post initial intervention)

研究者

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

Eugene Roh

Clinical Associate Professor

Stanford University

研究点 (1)

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