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临床试验/NCT03545048
NCT03545048已完成不适用

A Randomized Controlled Trial Evaluating the Efficacy of Internet-Based Exercise Program Aimed at Treating Knee Osteoarthritis (iBEAT-OA)

University of Nottingham1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2018年10月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
105
试验地点
1
主要终点
Knee pain measured on Visual Analogue Scale

研究概览

简要总结

  1. To test whether internet-based exercises reduce the pain in knee OA
  2. To check whether internet-based exercises improve the physical activity in the patients with knee OA.
  3. To explore the correlation between sleep, knee inflammation (effusion, synovial hypertrophy or/and synovial hyper vascularity) and biomarkers of insulin resistance and knee pain.

详细描述

Osteoarthritis is the most common cause of disability in the elderly population and most individuals suffering from osteoarthritis is managed in the primary care setting (1). Knee osteoarthritis is a most common form of arthritis in the world (2). The rate of knee arthritis is as high as that of cardiac disease and is the most common problem in the individuals over the age of 65 (3). In the United Kingdom, 10% of 65-74-year-old individuals consult their general practitioners about osteoarthritis per year (4). 4% population attend their general practitioners as a result of knee osteoarthritis and half of them (2%) consult their general practitioner for the first time or with the acute flare of knee arthritis (1).

According to national and international guidelines, the first line treatment for osteoarthritis pain (OA) is non-surgical; exercise, information and, in relevant cases, weight loss (5-9). There is enough evidence for the effectiveness of exercises in the management of knee osteoarthritis and to improve the functional capacity of these individuals to cope better with the activities of daily living (10-24). In fact, one study reported a slow down of progressive radiographic changes of knee OA as a result of strengthening exercises (25).There is a significant disparity on the effectiveness of different types of exercises for the knee osteoarthritis, and a combination of open and closed isotonic exercises are recommended knee osteoarthritis (26) with the exception to those individuals who find these exercises difficult and painful. In such groups, isometric exercises of knee muscles should be considered (26). In an attempt to manage the knee osteoarthritis, one can exacerbate the symptoms of knee arthritis by following ineffective or unsafe exercises leading to poor prognosis and poor adherence to these exercises (27), hence one should choose the exercises carefully.

As knee arthritis is a significant issue in the elderly population, therefore, the less expensive community-based approach will be beneficial for these patients. There are previous studies which have assessed the efficacy of home-based exercises and reported good results (12, 14, 28) however there are only a few studies which looked at the web-based exercises on the knee arthritis (29-33). Unfortunately, most of these studies recruited patients with knee pain, and radiographic evidence of knee osteoarthritis was undermined except one study (31). It infers that these web-based exercises can be used for knee pain which may include cases of soft tissue injuries, arthritic knee or any other reason for knee pain. However, generalising these results on the group of patients with knee osteoarthritis warrants a risk of increasing their pain just in case that those exercises are strenuous or more demanding.

The aim of this study is to explore the benefits of web-based exercises in the patients with knee osteoarthritis to establish if their pain decreases after six weeks. Being a web-based set of activities, it makes it more accessible to the patients living in rural areas and should make it more cost-effective requiring no travelling time. Our study is different from the other studies as there is not a single study (to our knowledge) which has studied web-based intervention on United Kingdom population of knee osteoarthritis. Furthermore, the investigators will endeavour to recruit only those individuals who have radiographic evidence of knee osteoarthritis. Therefore, this study will produce recommendations for the clinical setups where most of the symptomatic patients have radiographic evidence of knee osteoarthritis. The investigators will be using a web-based exercises platform known as Joint Academy (JA) as recent pilot studies (32, 33) demonstrated promising results for this platform. This programme is based on Swedish face to face self-management program known as 'Artrosskolan' (The Osteoarthritis School) which provides structured information and exercises for knee arthritis to the relevant population suffering from knee arthritis. The efficacy of it is covered elsewhere (34). The company that produced the Joint Academy platform has given consent to use their web based platform to conduct this study.

The investigators will recruit 134 individuals with the clinical evidence of radiographic knee arthritis, and these will be randomised into a control group and an interventional group (67 individuals in each group). The interventional group will get the login details for the Joint Academy (JA), and they will follow the strengthening exercises for six weeks with educational material online relevant to knee osteoarthritis. They will record their pain levels on the Numerical rating scale (NRS) at baseline and at the end of the trial. The validity and sensitivity of NRS have been established numerous times (35-39). Other than determining the subjective pain levels, the investigators will use standardised quantitative sensory testing (QST) such as pressure pain threshold (PPT), temporal summation (TS) and conditioned pain modulation (CPM). Pressure Pain threshold (PPT) has been used in previous studies done on the knee arthritis and deemed to be a valid and reliable method to establish tenderness around the knee joint (40-45). Similarly, temporal summation (TS) has been used in previous studies (40, 43, 44, 46) to establish whether individuals have an element of central sensitisation thus amplifying their localised knee pains. Conditioned pain paradigms are commonly used to assess the function of endogenous pain inhibitory pathways in humans. In this technique, a painful test stimulus is evaluated in the absence and in the presence of a second painful (conditioning) stimulus applied to a remote region of the body. In a typically functioning nociceptive system, the amount of pain experienced with the primary test stimulus will be reduced during the presentation of the secondary conditioning stimulus (47-49). Decreased inhibition of experimental pain is found in many patients with idiopathic pain syndromes (50-58). It predicts the tendency to develop future chronic pain (59, 60). The purpose of using QST is to establish objective data as to whether these exercises reduce the localised tenderness or global central sensitisation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •Aged 45 years and onward.
  • •Clinical diagnosis of knee arthritis with complaints of knee pain for 3-6 months, early morning stiffness <30 minutes, crepitus, bony tenderness, and no palpable warmth and radiographically established osteoarthritis (at least score 1 on K/L scale)
  • •Able to read and write English
  • •Able to use/access computer or tablet and have access to internet

排除标准

  • •Inability to give informed consent - (capacity levels are already established under General practitioner care)
  • •Terminal or mental illness
  • •Neurological conditions, inflammatory joint diseases including rheumatoid arthritis, gout or calcium pyrophosphate deposition disease (CPPD), and dementia
  • •Patients with sleep apnea
  • •Acute soft tissue injury to the knee within last 3 months before recruiting
  • •Unstable heart condition or rapid fluctuations in hypertension

研究组 & 干预措施

Intervention arm

Experimental

Interventional groups will have an assessment session with the experienced staff and NRS, QST, WOMAC, MSK-HQ, 30CST, TUG, PSQI, MSK-USS, urine and blood samples will be taken at baseline. Those who consent for aspiration of synovial fluid will go through the USGA procedure.

Interventional group will shortly after that receive a link via email, which will be used to log-in to Joint Academy online portal. After log-in has been achieved, the intervention starts. It consist of a 6-week internet-based physical therapy program. Interventional group will be given actigraphy device (a device to monitor sleeping pattern) which is CE marked. Therefore, their sleeping pattern can be recorded quantitatively.

Once exercises programme is finished in six weeks, the participants will fill in the same questionnaire and perform the physical tests, to enable evaluation.

干预措施: Internet based exercises (Other)

Control arm

No Intervention

Control group will continue with their routine self-management which is offered in the community setup. They will be assessed on NRS, QST, WOMAC, MSK-HQ, PSQI, 30CST, TUG, isometric muscles strengthen of quadriceps, MSK-USS, muscle mass of vastus lateralis, urine and blood samples at baseline. Control group will also get the actigraphy to monitor sleeping pattern of that group. They will be re-assessed after six weeks on the primary objective measures to see if they have made any difference by following self-management strategies in the community.

结局指标

主要结局

Knee pain measured on Visual Analogue Scale

时间窗: 6 weeks

knee pain scored on 00- 10 (00 no pain and 10 being worst pain)

次要结局

  • Pittsburgh sleep quality index (Sleep disturbances )(6 weeks)
  • Quantitative Sensory Testing (Pressure pain threshold - PPT)(6 weeks)
  • The Timed Up and Go test (TUG)(6 weeks)
  • Temporal Summation (TS)(6 Weeks)
  • Ultrasound of the knee(6 weeks)
  • Muscle mass on musculoskeletal ultrasound(6 weeks)
  • Western Ontario and McMaster Universities Osteoarthritis Index(6 weeks)
  • The 30 seconds sit to stand test(6 weeks)
  • Continuous Pain Modulation (CPM)(6 weeks)
  • General health questionnaire (MSK-HQ)(6 weeks)

研究者

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

Sameer Gohir

PhD student, Extended Scope Practitioner, MSK sonographer

University of Nottingham

研究点 (1)

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