Assessment of Short-term Effectiveness of Five Local Treatment Modalities in Patients With Symptomatic Knee Osteoarthritis: a Randomized Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 主要终点
- WOMAC 3.1 Index total
研究概览
简要总结
BACKGROUND: Current medical treatment strategies for knee osteoarthritis (OA) are aimed at pain reduction and symptom control. The Non-Arthroscopic Joint Lavage (NAJL) is included inside the therapeutic algorithm of knee OA when other therapies are contraindicated or have lost effectiveness. The large variety of potentially invasive interventions available (joint lavage included) has raised the need to assess their efficacy. The objective of this study is to compare the short-term effectiveness of five treatment strategies in patients with knee osteoarthritis (OA).
METHODS: It was conducted a randomized prospective study involving 150 patients of whom 76.7% were females. The age range was 40-81 years. All patients had knee OA according to the American College of Rheumatology criteria, with Kellgren-Lawrence radiographic grades II and III. Patients were assigned to five groups, 1) non-arthroscopic joint lavage (NAJL) (n= 30), 2) NAJL plus hyaluronic acid (HA) (n= 32), 3) NAJL plus corticosteroid (CS) (n= 32), 4) HA (n= 31), 5) CS (n= 25). Evaluations took place at baseline, one and three months after enrollment. Demographic variables, Western Ontario and McMaster University Osteoarthritis Index (WOMAC) and Lequesne scores were recorded. Statistical analysis included mixed analysis of variance, post-hoc comparisons with Sidak's adjustment, and multiple linear regression using as outcome WOMAC total at 3 months.
TRIAL REGISTRATION: The protocol of the study was approved by the "Hospital Universitario Reina Sofía" Ethics Committee, under the number 1996, in the Minutes 208 of 29 May 2012.
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
- 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
- 否
入选标准
- •Meeting American College of Rheumatology (ACR) criteria for knee OA, symptoms for at least three months despite conservative medical treatment, knee OA grade II or III on the radiological Kellgren-Lawrence scale, and voluntary collaboration.
排除标准
- •ankylosis of joint;
- •total arthroplasty or previous osteotomy
- •infected injury;
- •treatment with dicumarinic drugs or alterations in blood coagulation,
- •venous insufficiency or episode of venous thrombosis;
- •administration of hyaluronic acid (HA) in the previous year, and/or corticosteroid (CS) infiltration or NAJL in the previous three months.
研究组 & 干预措施
Non arthroscopic joint lavage (NAJL)
Establishment of sterile areas and cleaning of the skin around the knee with a povidone-iodine solution, followed by an injection of local anesthetic (5 mL of 2% mepivacaine hydrochloride) into the outer mediopatellar zone. The anesthetic was allowed to act, and an access way was then opened with a No. 16 abocat. Any effusion in the joint was drained. Then, approximately 100 mL of cold saline was instilled through the outer access way. Once the knee was distended, a further 5 mL of local anesthetic was injected into the inner mediopatellar zone, and a new abocat guide was used to establish the inner drainage way. The lavage proper involved instillation of 4 L of cold (8ºC) saline at a constant flow-rate using a dropper line connected to the entry way; the inner zone was also connected to another, free-fall dropper.
干预措施: Non arthroscopic joint lavage (Procedure)
Non arthroscopic joint lavage plus corticosteroid
Establishment of sterile areas and cleaning of the skin around the knee with a povidone-iodine solution, followed by an injection of local anesthetic (5 mL of 2% mepivacaine hydrochloride) into the outer mediopatellar zone. The anesthetic was allowed to act, and an access way was then opened with a No. 16 abocat. Any effusion in the joint was drained. Then, approximately 100 mL of cold saline was instilled through the outer access way. Once the knee was distended, a further 5 mL of local anesthetic was injected into the inner mediopatellar zone, and a new abocat guide was used to establish the inner drainage way. The lavage proper involved instillation of 4 L of cold (8ºC) saline at a constant flow-rate using a dropper line connected to the entry way; the inner zone was also connected to another, free-fall dropper. Following administration of the joint lavage, the NAJL plus corticosteroid group was given an intra-articular injection containing 40 mg of triamcinolone acetonide.
干预措施: Non arthroscopic joint lavage plus corticosteroid (Procedure)
Non arthroscopic joint lavage plus hyaluronic acid
Establishment of sterile areas and cleaning of the skin around the knee with a povidone-iodine solution, followed by an injection of local anesthetic (5 mL of 2% mepivacaine hydrochloride) into the outer mediopatellar zone. The anesthetic was allowed to act, and an access way was then opened with a No. 16 abocat. Any effusion in the joint was drained. Then, approximately 100 mL of cold saline was instilled through the outer access way. Once the knee was distended, a further 5 mL of local anesthetic was injected into the inner mediopatellar zone, and a new abocat guide was used to establish the inner drainage way. The lavage proper involved instillation of 4 L of cold (8ºC) saline at a constant flow-rate using a dropper line connected to the entry way; the inner zone was also connected to another, free-fall dropper. Following administration of the joint lavage, the patients were given an intra-articular injection containing 4 ml of a bioengineered hyaluronic acid.
干预措施: Non arthroscopic joint lavage plus hyaluronic acid (Procedure)
Intraarticular injection of hyaluronic acid
Establishment of sterile areas and cleaning of the skin around the knee with a povidone-iodine solution. This was followed by an intraarticular injection containing 4 mL of a bioengineered hyaluronic acid.
干预措施: Intraarticular injection of hyaluronic acid (Procedure)
Intraarticular injection of corticosteroid
Establishment of sterile areas and cleaning of the skin around the knee with a povidone-iodine solution. This was followed by an intraarticular injection containing 40 mg of triamcinolone acetonide.
干预措施: Intraarticular injection of corticosteroid (Procedure)
结局指标
主要结局
WOMAC 3.1 Index total
时间窗: WOMAC total at 3 months
The WOMAC (Western Ontario and McMaster Universities) index is used to assess patients with osteoarthritis of the hip or knee and contains 24 questions, targeting areas of pain, stiffness and physical function. It can be used to monitor the course of the disease or to determine the effectiveness of anti-rheumatic medications. In the study it was used the validated Spanish version of the 5-point adjectival scale format (possible answers are none -0 points-, slight -1 point-, moderate -2 points-, severe -3 points- and extreme -4 points-). The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). WOMAC total is the sum of the three components and it ranges from 0 to 96 points, being 96 the worst outcome.
次要结局
- Lequesne Index(baseline, at one month and at three months)
- WOMAC 3.1 Index pain(WOMAC pain at three months)
- WOMAC 3.1 Index stiffness(WOMAC stiffness at three months)
- WOMAC 3.1 Index total(WOMAC total at one month)
- WOMAC 3.1 Index function(WOMAC function at three months)