Skip to main content
Clinical Trials/NCT03545048
NCT03545048CompletedNot Applicable

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

University of Nottingham2 sites in 1 country105 target enrollmentStarted: October 15, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
105
Locations
2
Primary Endpoint
Knee pain measured on Visual Analogue Scale

Study Overview

Brief Summary

  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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
45 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Knee pain measured on Visual Analogue Scale

Time Frame: 6 weeks

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

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sameer Gohir

PhD student, Extended Scope Practitioner, MSK sonographer

University of Nottingham

Study Sites (2)

Loading locations...

Similar Trials