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临床试验/NCT05992883
NCT05992883招募中3 期

NSAID Injection Versus Corticosteroid Injection for Basilar Thumb Arthritis: A Randomized, Controlled Trial

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2023年7月28日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
招募中
发起方
Mayo Clinic
入组人数
240
试验地点
1
主要终点
Visual Analogue Scale (VAS) of Pain

研究概览

简要总结

The Researchers are trying to compare two different types of intraarticular injections (injection in the joint) for treating the symptoms of moderate to advanced basilar thumb arthritis. One injection is ketorolac (an NSAID) and the other is triamcinolone (a corticosteroid).

详细描述

Cartilage degeneration resulting in osteoarthritis is the most common and costly musculoskeletal disorder in the United States, with basilar thumb arthritis being one of the most common manifestations of this disease. Despite its prevalence and previous research on treatments for the disease, there is a dearth of efficacious and low-cost interventions for trapeziometacarpal arthritis. Of these nonoperative interventions, intraarticular corticosteroid injections are the most popular and have the most evidence indicating their benefit. However, long-term use of corticosteroids has a well-established degenerative effect that is counterproductive to preserving cartilage and bone of the CMC joint. Novel, disease-modifying osteoarthritis treatments such as platelet rich plasma and human recombinant bone morphogenic protein 7, among others, are alternative options for patients. Many of these are currently in advanced development, but to date none have achieved FDA approval, and all are significantly more expensive and have limited availability compared to intraarticular corticosteroids.

Although used infrequently, non-steroidal anti-inflammatory drugs (NSAIDs) are another modality of nonoperative intervention for basilar thumb arthritis. Intraarticular injections of NSAIDs have demonstrated success in alleviating the symptoms of primary arthritis in the hip and knee without concern of systemic side effects compared to oral NSAID use. Additionally, injectable NSAIDs are significantly more cost-effective compared to other injectables and do not have the chondrotoxic profile of corticosteroids. However, there are few studies directly comparing intraarticular NSAID use to other injectable therapies.

Given the potential clinical and economic benefits of injectable NSAID therapy, we propose a clinical trial investigation examining the efficacy of intraarticular ketorolac versus intraarticular triamcinolone in treating symptoms of moderate to advanced primary osteoarthritis of the basilar thumb. The prospect of successfully alleviating symptoms of joint degeneration without propagating the progression of disease would be invaluable to the thousands of patients in the Mayo Clinic system and elsewhere afflicted with basilar thumb arthritis without the means or ability to pursue stem cell therapeutics or more definitive, operative intervention.

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, Care Provider)

盲法说明

After enrollment and completion of the initial clinical evaluation, patients will undergo the injection procedure while blinded to the medication they receive. The injecting physician will also be blinded to the medication being administered.

入排标准

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

入选标准

  • Adults >40 years of age
  • Pain at the thumb base brought on by direct pressure (grind test) and with movement
  • Pain resistant to previous conservative management (including over the counter medications (ibuprofen/acetaminophen), icing, splinting/braces, or topical analgesics)
  • Radiological observation indicative of arthritis based on the Eaton-Littler classification system (stages 1 through 4)
  • Patient understands the protocol and signed the informed consent
  • Patient is covered by health insurance

排除标准

  • • Known allergy to either of the treatment products
  • Patient's analgesic treatment regimen or other modalities of managing symptoms/pain associated with their hand pathology was modified within four weeks before trial inclusion
  • Symptomatic Scaphoid-trapezial arthritis present
  • Localized or systemic infection
  • Previous thumb surgery on study thumb
  • Previous thumb injury on study thumb
  • Patient with inflammatory arthritis (e.g., rheumatoid arthritis, psoriatic arthritis)
  • Severe and/or uncontrolled hypertension
  • De Quervain tendinopathy present
  • History of injection to the trapeziometacarpal joint on study thumb within the previous 6 weeks
  • Uncontrolled diabetes
  • Pregnant or lactating females. Female participants of childbearing potential must have a negative pregnancy test before the injection. Women without childbearing potential (ie., surgically sterile with hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy OR ≥ 12 months of amenorrhea and at least 50 years of age) are eligible to participate without completing a pregnancy test.
  • Immunodeficient patients
  • Patients that are currently using nicotine products, or who have quit in the last 12 months
  • Patients under guardianship, curatorship, or are otherwise not self-sufficient
  • Patients participating in another clinical research trial which interferes with this study protocol or outcomes
  • Patients unable to follow the protocol in the investigators' judgement.

研究组 & 干预措施

Non-steroidal anti-inflammatory drug (NSAID)

Experimental

Patients will proceed to their injection appointment within 4 weeks of their initial evaluation. At the injection appointment, patients will receive an injection containing 1.0 mL of ketorolac 15 mg/mL (15 mg total of ketorolac).

干预措施: Ketorolac (Drug)

Corticosteroid

Active Comparator

Patients will proceed to their injection appointment within 4 weeks of their initial evaluation. At the injection appointment, patients will receive an injection containing 0.5 mL of triamcinolone 40 mg/mL (20 mg total of triamcinolone).

干预措施: Triamcinolone (Drug)

结局指标

主要结局

Visual Analogue Scale (VAS) of Pain

时间窗: At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.

Patient-reported VAS score with both motion and rest of the CMC joint. The VAS is a 11-item questionnaire assessing pain. Using a scale of 0 = no pain to 10 = worst pain. Total scores range from 0 - 110, lower scores indicating lower pain and higher scores indicating greater pain.

次要结局

  • Michigan Hand Outcomes Questionnaire (MHQ)(At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.)
  • Grip Strength(At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.)
  • Apposition Strength(At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.)
  • Opposition Strength(At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marco Rizzo

Principal Investigator

Mayo Clinic

研究点 (1)

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