Hypertonic Dextrose Versus Corticosteroid Intra-Articular Injections for the Treatment of Trapeziometacarpal Arthritis: A Prospective Double-blind Randomized Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 130
- 主要终点
- post-injection pain
研究概览
简要总结
The evolving reports form recent studies are creating a promise on the potential use of dextrose injections for treating arthritis and replacing current method of treating early osteoarthritis by corticosteroids by giving long standing effect and improving patients' symptoms and function. Over the past 5 years, an increasing number of level I and level II studies have emerged, examining the effect of intra-articular prolotherapy for the treatment of both hip and knee osteoarthritis. On the contrary, there is limited data in small joints, such as the temporomandibular joint.
详细描述
Carpometacarpal osteoarthritis (OA) is a degenerative condition of the hand that causes pain, stiffness and weakness. It is the second most common site of degenerative disease in the hand after arthritis of the distal interphalangeal joints. The prevalence of symptomatic hand OA in people over 70 years of age has been estimated as 13.4 % for men and 26.2 % for women. OA is more frequent in older age groups, leading to considerable disability with a burden on health services and on the economy. Risk factor for carpometacarpal osteoarthritis of the thumb includes being female, middle age, previous trauma, repetitive use and inflammatory joint disease. Lifetime prevalence of this condition approaches 10%.
Injections are a useful conservative treatment modality prior to considering surgical treatment. Corticosteroid injection is helpful in the treatment of the disease, but some patients gain only short-term benefits. Evolving reports are showing promising results for the application of dextrose as an alternative method for the treatment of Carpometacarpal osteoarthritis, based on their induction for growth factors and inflammatory mediators. For instance, prolotherapy has been used as a treatment of musculoskeletal pain with various etiologies. It has been suggested that prolotherapy induces little inflammation and stimulates endogenous repair especially by prompting release of growth factors. Dextrose is an agent commonly used for prolotherapy.
The evolving reports form recent studies are creating a promise on the potential use of dextrose injections for treating arthritis and replacing current method of treating early OA by corticosteroids by giving long standing effect and improving patients' symptoms and function. Over the past 5 years, an increasing number of level I and level II studies have emerged, examining the effect of intra-articular prolotherapy for the treatment of both hip and knee osteoarthritis. On the contrary, there is limited data in small joints, such as the temporomandibular joint.
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)
盲法说明
The clinical assessor is blinded to the baseline evaluations and to the administered treatments. Information about the medications used in the study will be given to the participants, but they will be blinded to their group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Those patients with diagnosis of carpometacarpal (CMC) osteoarthritis
- •Those patients who fit the age limits
排除标准
- •Those patients outside of the age limits
- •Those patients with systemic rheumatic disease, comorbid hand conditions (such as carpal tunnel syndrome or De Quervain's tenosynovitis), gout, pseudogout
- •Those patients with a predisposition to bleeding issues
- •Those patients with previous surgery to the affected thumb
- •Those patients with previous injection to the involved thumb base within the past 12 months
- •Those patients with severe X-ray osteoarthritis of grade IV (Eaton and Littler classification) and no evidence of CMC joint space narrowing on plain radiographs
研究组 & 干预措施
Dextrose Group
Injection for Group A: A 27-gauge needle to be inserted in the 1st CMC joint, at which time 0.5 ml of 15% dextrose mixed with 0.5 ml of 1% lidocaine solution is injected into intra and peri-articular area.
干预措施: Dextrose (Drug)
Methylprednisolone Acetate Group
Injection for Group B: A 27-gauge needle to be inserted in the 1st CMC joint, at which time 0.5 ml of 40mg methylprednisolone acetate mixed with 0.5 ml of 1% lidocaine solution is injected into intra and peri-articular area.
干预措施: Methylprednisolone Acetate 40 MG/ML (Drug)
结局指标
主要结局
post-injection pain
时间窗: 1 day
visual analog score for pain (0 for no pain, 10 for worst pain)
post-injection functionality
时间窗: 1 day
Q-DASH score for functionality (0 for no disability, 100 for most disability)
次要结局
未报告次要终点