Structured Non-operative Treatment of Knee Osteoarthritis - a Randomized Controlled Trial of Pain, Physical Function and Quality of Life With 12months Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Change From Baseline in KOOS4 (Knee Injury and Osteoarthritis Outcome Score)
研究概览
简要总结
The purpose of this study is to test whether an algorithm for systematic non-surgical treatment consisting of corrective insoles, neuromuscular training, weight loss, patient education and pharmacological treatment with paracetamol, non steroidal anti inflammatory drugs (NSAIDs) and Pantoprazole provides further improvement in pain, function and quality of life than standard non-surgical treatment (information on the disease and how to treat it) in patients with knee osteoarthritis.
The H1-hypothesis is that the treatment algorithm results in a greater increase in quality of life and functional capacity and greater reduction in pain than standard treatment at the primary endpoint, which is follow-up 12months after the start of the treatment.
See statistical analysis plan available under "Links" for further description of the study.
详细描述
Knee osteoarthritis (OA) is the degenerative joint disease that most often requires treatment and at the same time the one associated with the greatest social costs. In addition, the disease has many personal costs and is greatly contributing to reduced functionality and autonomy of older adults.
It is recommended both nationally and internationally that the treatment of knee osteoarthritis should include multiple treatment modalities. Clinical guidelines recommend that exercise, weight loss and patient education is the first step in treatment and that insoles and pharmacological treatment can be included as a supplement.
However if the patient is not a candidate for total knee replacement, the patient most often receives only information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse. This postponement of treatment can lead to a worsening of pain and function and a worse outcome after treatment. Therefore, the current treatment strategy for the patient group is problematic.
The current practice may be due to the lack of studies with high level of evidence that have examined the optimal non-operative treatment approach and compared it with the current standard treatment for this group of patients.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Knee-OA detected by x-ray (Kellgren & Lawrence grade 1 or greater)
- •KOOS4 of ≤ 75
- •Considered not to be a candidate for Total Knee Replacement (TKR) by the orthopedic surgeon.
- •The participant is > 18 years of age.
- •The participant can provide relevant and adequate, informed consent.
排除标准
- •Prior TKA ipsilateral
- •Rheumatoid arthritis
- •Mean VAS > 60mm the last week on a 0-100mm scale
- •Possible pregnancy or planning pregnancy;
- •Inability to comply with the protocol;
- •Inadequacy in written and spoken Danish.
研究组 & 干预措施
MEDIC
Medicine, Exercise, Diet, Insole and Cognitive/patient education (MEDIC) for three months.
干预措施: Neuromuscular training (NEMEX-TJR) (Other)
MEDIC
Medicine, Exercise, Diet, Insole and Cognitive/patient education (MEDIC) for three months.
干预措施: Paracetamol (Drug)
MEDIC
Medicine, Exercise, Diet, Insole and Cognitive/patient education (MEDIC) for three months.
干预措施: Burana (Drug)
MEDIC
Medicine, Exercise, Diet, Insole and Cognitive/patient education (MEDIC) for three months.
干预措施: Pantoprazole (Drug)
MEDIC
Medicine, Exercise, Diet, Insole and Cognitive/patient education (MEDIC) for three months.
干预措施: Dietary counseling (Behavioral)
MEDIC
Medicine, Exercise, Diet, Insole and Cognitive/patient education (MEDIC) for three months.
干预措施: Patient education (Behavioral)
MEDIC
Medicine, Exercise, Diet, Insole and Cognitive/patient education (MEDIC) for three months.
干预措施: Insoles (Other)
Standard treatment
Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.
干预措施: Information (Behavioral)
结局指标
主要结局
Change From Baseline in KOOS4 (Knee Injury and Osteoarthritis Outcome Score)
时间窗: Primary: 12months.
The average score for four of the five KOOS subscales, covering pain, symptoms, difficulties in functions of daily living, and quality of life (KOOS4), with scores ranging from 0 (worst) to 100 (best). Between group comparisons of treatment effect (change in KOOS4 from baseline to 1 year follow-up) will be dependent on data distribution. We expect the change to be normally distributed and analysis will be made using a mixed model ANOVA with subject being a random factor and visit (baseline, 3, 6 and 12 months), treatment arm (TKA + MEDIC, MEDIC) and site (Frederikshavn, Farsoe) being fixed factors. Baseline KOOS4 will be a covariate. Furthermore interactions between the fixed factors will be included in the model. P-values and 95% CI will be presented to assess superiority.
次要结局
- Change From Baseline in 20-meter Walk(Primary: 12months.)
- Change in the Five KOOS Subscale Scores From Baseline(Primary: 12 months.)
- Proportion of Users of Pain Medication(Baseline and 12months.)
- Change From Baseline in EQ-5D(Primary: 12months.)
- Weight Change in kg From Baseline(Primary: 12months.)
- Number of Serious Adverse Events Reported at Index Knee(Primary: 12months.)
- Change From Baseline in Time From the Timed Up and Go(Primary: 12 months.)