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临床试验/NCT02091674
NCT02091674已完成2 期

Management of Acute Ankle Sprain With Sodium Hyaluronate (AdantTM) Periarticular Injections

Lawson Health Research Institute0 个研究点目标入组 32 人开始时间: 2013年8月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
32
主要终点
VAS of pain on weight-bearing

研究概览

简要总结

To determine the efficacy and safety of hyaluronic acid (AdantTM, Tedec-Meiji Farma SA) for acute ankle sprain, a single-site, open-label, controlled trial will be conducted.

The study will be conducted in a sport-medicine clinical research center in London, Ontario, Canada. The eligible patients will be 18 years of age and older, have first or second degree lateral sprain within 48h of the start of the treatment, and moderate or severe pain (>45mm on 100 mm pain visual analogue scale /VAS). Exclusion criteria will include bilateral ankle sprain, ipsilateral knee trauma, prior sprain in the past 6 months, use of NSAID prior to entry, intra-articular ankle injection in the prior 6 months.

The patients will receive standard care (RICE and rescue analgesics), and a single 2.5cc Adant periarticular ankle injection following provision of informed consent and collection of baseline data. NSAIDs, corticosteroids or topical analgesics will not be allowed.

Assessments will be done at baseline, days 8, 30 and day 90. Efficacy measures will include patient's pain VAS on weight bearing (0-100mm) and walking 20m (0-100mm), patients' global assessment of ankle injury (5 point categorical scale), patients' assessment of normal function/activity (5 point categorical scale), physician's global assessment of ankle injury (5 point categorical scale), patients/physician satisfaction assessment (10 point categorical scale), time to return to pain-free and disability-free sport and adverse events as per WHO definition.

It is expected that the Hyaluronic acid injections will decrease pain and swelling, promote healing, improve time to return to sport and increase mobility.

详细描述

Ankle sprains are among the most common of all sports injuries, with approximately two million people per year seeking medical treatment (1, 2, 3). An epidemiological study of professional, competitive, and recreational athletes found a prevalence of ankle sprain as high as 73% (4). Data from the National Hospital Ambulatory Medical Care Survey: 2000 Emergency Department (ED) Summary listed about 1.375 million ED visits in the US due to ankle sprains which represent about 1.3% of ED visits (5).

Ankle sprains most commonly affect the lateral ligament complex. The lateral ligament complex of the ankle consists of three separate ligaments: anterior talofibular, posterior talofibular and calcaneofibular. The anterior talofibular ligament is usually the ligament affected although in more severe injuries the calcaneofibular ligament may also be involved. Varus or inversion sprains include a spectrum of severity. Symptoms may include pain, swelling, tenderness and functional loss. Ankle sprains are classified as first-, second- or third-degree ankle sprains. A first-degree sprain represents a partial tear of a ligament with mild tenderness and swelling, a second-degree sprain represents incomplete tear of a ligament with moderate functional impairment, pain and swelling, and a third-degree sprain represents a complete tear and loss of integrity of a ligament and presents with severe swelling, ecchymosis, loss of function and mechanical instability (6, 7). The assessment and treatment of an ankle injury may be performed by emergency and primary health care physicians as well as orthopaedic and trauma surgeons (8).

The emphasis of therapy in ankle sprains is centered on reducing the inflammation and pain rapidly following injury (7, 9). Guidelines for the treatment of acute ankle sprain from the American Academy of Orthopaedic Surgeons recommend initial rehabilitation program (up to three weeks) with NSAIDs (non steroidal anti inflammatory drugs), RICE (rest, ice, compression and elevation) as well as protected weight bearing, early mobilization and isometrics (10). Conservative treatment may limit disability to an average of 8 days for a grade 1 and 15 days for a grade 2 (3). Failure to provide adequate therapy can limit a patient's efforts in rehabilitation and prolong the recovery period. In a study of ankle sprain, pain and dysfunction was found to persist 6 to 18 months (average 12.8 months) after initial ankle sprain in 73% of patients, with 40% reporting inability to walk one mile, and 11% continuing to use medications for ankle symptoms (11). In a long-term follow-up study, nearly 40% of patients reported residual long-term symptoms and dysfunction 6.5 years after initial ankle sprain (12). Also, long-term symptoms of ankle sprain have been noted by 40% of athletes 6 months after acute injury (6).

NSAIDs effectively reduce the inflammation, pain, and disability associated with acute ankle sprain (13, 14). The rationale for their use includes 1) pain control, 2) anti-inflammatory effect to allow early activity and 3) decrease inflammation to speed healing directly. However, NSAIDs are nonselective and may cause significant adverse events including UGI intolerance and serious events such as ulcers and bleeding.

Hyaluronic Acid is a naturally occurring biological substance which has shown to have a positive effect in viscosupplementation therapy. As it relieves pain and stiffness related to osteoarthritis, it may have a similar effect on the ligaments affected by acute ankle sprain in regards to anti-inflammatory effects. This would promote the mobility and decrease the pain associated with acute ankle sprains. Hyaluronic Acid has no effect on UGI and platelet function compared to traditional NSAIDs as it works locally within the site of injection.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • 18 years and older
  • first or second degree lateral ankle sprain within 48 h of administration of study drug
  • reported moderate (45 - 60 mm) to severe (>60 mm) ankle pain on full weight bearing on the Patient's Assessment of Ankle Pain using a 100 mm VAS
  • available for the duration of the study (90 days)

排除标准

  • • Bilateral ankle sprain
  • Ipsilateral knee injury
  • Third-degree sprain
  • Previous ankle sprain within 6 months
  • Patients who had recently used anti-inflammatory medications, muscle relaxants psychotropic medications that could confound the results
  • Patients with a history of severe GI, renal, or hepatic disease
  • Patients with rheumatic diseases
  • History of drug or alcohol abuse
  • Pregnant or lactating, or a woman of childbearing potential not willing to use an acceptable method of contraception during the study
  • Having received investigational product within 30 days of the Day 1 visit

结局指标

主要结局

VAS of pain on weight-bearing

时间窗: up to 90 days

Visual analogue score for pain (0-100mm) on weight-bearing

次要结局

未报告次要终点

研究者

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

Rob Petrella

Research Chair

Lawson Health Research Institute

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