Condition category
Musculoskeletal Diseases
Date applied
27/01/2020
Date assigned
07/02/2020
Last edited
07/02/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Chronic knee pain is a common problem. It can happen for a number of reasons, and it can make it difficult to walk and function in everyday life. The knee joint is complex, and a range of factors can lead to damage and pain. When the components of the knee are not working properly, pain, inflammation, and other symptoms can occur.
This study, which is funded by Versus Arthritis, aims to evaluate how feasible and acceptable two electronic rehabilitation (e-rehabilitation) programmes are when used to treat patients with chronic knee pain. The acceptability and experiences of the physiotherapists delivering the interventions will also be explored. The study will build on and expand for use in the UK, e-rehabilitation programmes that have been developed in Australia.

Who can participate?
Adults aged > 45 years with chronic knee pain who have access to the internet at home and on their smartphone.

What does the study involve?
Patients with knee pain who meet the inclusion criteria will be recruited from the Leeds Community Healthcare Musculoskeletal Service. They will then be randomised to receive one of the two e-rehabilitation programmes (Group E-Rehab or MyKneeExercise), or ‘usual care’ (one or two NHS physiotherapy clinic visits with an exercise leaflet to continue exercises at home) fo a period of nine months. Participants will be informed of their randomisation allocation via email or telephone. The ‘Group E-Rehab’ intervention is an Internet-delivered physiotherapist-prescribed home exercise programme, and physiotherapists will be trained to deliver this. The ‘MyKneeExercise’ intervention is home web-based and no physiotherapist input is required to deliver this e-rehabilitation programme.
The feasibility and acceptability of these interventions will then be explored using data collected through questionnaires and interviews, and the study will assess the potential use of the e-rehabilitation programmes by physiotherapists in community care settings.

What are the possible benefits and risks of participating?
Taking part in this study may or may not directly benefit participants but it will help researchers to see whether treating individuals with chronic knee pain using the Internet is feasible. If it is, then a larger scale study may follow.
There are no risks associated with taking part in this study, there is just the slight inconvenience of being asked to complete three study questionnaires and for some, also taking part in an the interview to get their views and opinions about the rehabilitation programme.

Where is the study run from?
Leeds Community Healthcare NHS Trust (UK)

When is the study starting and how long is it expected to run for?
January 2020 to December 2020

Who is funding the study?
1. Versus Arthritis (UK)
2. National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Dr Dawn Groves
d.groves@leeds.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Dawn Groves

ORCID ID

Contact details

LIRMM
Level 2 Chapel Allerton Hospital
Chapeltown Road
Leeds
LS7 4SA
United Kingdom
+44 (0)113 392 4869
d.groves@leeds.ac.uk

Type

Scientific

Additional contact

Dr Sarah Kingsbury

ORCID ID

Contact details

LIRMM
Level 2 Chapel Allerton Hospital
Chapeltown Road
Leeds
LS7 4SA
United Kingdom
+44 (0)113-39-24878
S.R.Kingsbury@leeds.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 43473, IRAS 269827

Study information

Scientific title

Evaluation of electronic-rehabilitation programmes for chronic knee pain

Acronym

Study hypothesis

Electronic-rehabilitation programmes can be delivered to individuals with chronic knee pain and is acceptable to individuals and health professionals.

Ethics approval

Approved 27/01/2020, West of Scotland REC 5 (West of Scotland Research Ethics Service
Ward 11, Dykebar Hospital, Grahamston Road, Paisley, PA2 7DE; +44 (0)141 314 0213; WoSREC5@ggc.scot.nhs.uk), ref: 20/WS/0006

Study design

Mixed methods interventional randomized controlled trial with follow-up interviews

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic knee pain

Intervention

Patients referred to the LCH musculoskeletal service with chronic knee pain will be provided with information about the study and invited to take part. The study will be advertised to current patients by having posters/leaflets in clinics, and additional potential participants will be identified from current/past chronic knee pain referral lists to the service. Potential participants will either be handed (if in a musculoskeletal clinic), or sent an invitation letter from LCH Trust, and they will also receive a contact form containing contact details for the research team at the University of Leeds, and a Participant Information Sheet.

Patients who would like to take part in the study will be initially screened for general eligibility, and then subsequently consented before clinical screening for inclusion/exclusion criteria. Consent will be requested to make audio-visual recordings of the Group rehab sessions. Potential participants who are not happy to consent to the sessions being recorded may not be eligible for this intervention. Participants who are eligible to take part will be randomly allocated into one of three groups in a 1:1:1 allocation ratio. They will receive either standard physiotherapy care (Control Group), a web-based home exercise programme with motivational text support system (MyKneeExercise), or a group Internet-delivered physiotherapist prescribed home exercise programme with additional Internet-interactive educational sessions (Group E-Rehab). It is proposed that there will be 30 participants in each group. Participants will be informed of their randomisation allocation via email or telephone.

Participants receiving the Group E-Rehab intervention will be given online access to standard education material and will be asked to complete four Internet-interactive educational modules. These will be completed at the participants own pace. The exercise aspect of this intervention will be delivered by a physiotherapist. This will consist of approximately seven group Skype/Zoom sessions delivered once a fortnight to groups of 5-6 participants, each lasting 45- 60 minutes. Participants will be given an introduction/’technical lesson’ to familiarise them with Skype/Zoom, and the physiotherapist will perform an assessment (Skype/Zoom visit 1). Individuals receiving Group E-Rehab will be given a lower-limb strengthening home exercise programme to do, which should be completed by the individual or group participants three times per week. It is proposed that two physiotherapists will be needed to deliver the Group E-Rehab intervention to 30 participants in total. Physiotherapists who are involved with the study will attend a one-day training course; and will be provided with a specific exercise manual.

Participants receiving the MyKneeExercise will be provided with a web-based home exercise programme and support to do physiotherapy prescribed exercises at their own pace, three times a week over 12 weeks. The programme contains various lower limb strengthening exercises (e.g. hamstring curl, knee extension, calf raises), and the website contains evidence-based information and videos for each exercise and general OA information and advice. Participants will be asked to complete an exercise log and will receive motivational text messages (2-5 per week), where they will also be asked to report their adherence to the exercise programme. The web site has been trialled with patients in Australia, however, any participant who is not managing the programme will be able to request a single appointment with a physiotherapist by completing the ‘make an appointment’ page on the MyKneeExercise website.

The interactive/electronic elements of the programmes and the physiotherapist training materials (for Group E-Rehab) will be developed and refined during Phase 1 of the study.

The control group will receive one/two physiotherapy sessions; and will be provided with an exercise sheet so they can continue with the exercises and rehabilitation at home.

All participants will be asked to complete a questionnaire (covering topics such as pain, function, health status, quality of life) at baseline and after three and nine months. To learn more about the individuals who are taking part in the study, additional information and basic demographic details such as age, sex, ethnicity, medical history (including history of chronic knee pain), joints affected (using a joint manikin), employment, and medications, will be collected at baseline. A resource use questionnaire to collect data in order to generate an estimate of the cost of delivering the interventions will also be used. The questionnaires will be sent by post.

Qualitative data collection:
On completion of the nine-month follow-up questionnaire, a sub-sample of participants from the two e-rehabilitation intervention study arms will be contacted and asked their views about the specific intervention they received as well as their experience of being in the study. This will be done using face-to-face interviews or by telephone, and will last approximately 45 minutes. Around 20 participants will be interviewed; the final number will be determined once data saturation has been reached.

The two physiotherapists who delivered the Skype/Zoom Group E-Rehab intervention will both be asked for feedback about their experience of the preparation, delivery and potential/actual barriers to the e-rehabilitation programme using semi-structured face-to-face interviews.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Feasibility of two different e-rehabilitation programmes:
1. Demonstration that participants and physiotherapists find e-rehabilitation acceptable and can be administered successfully
2. Calculation of a sample size from the feasibility study that can be achieved in a main trial
3. At most 30% attrition at 3 months
4. At least 40-50% of eligible patients recruited into the study

Secondary outcome measures

1. Pain is measured using a joint pain manikin, 5-point scale (frequency of pain), a medication use questionnaire, and Part 1 of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), at baseline, and at three and nine months
2. Quality of life is measured using the 12-Item Short Form Survey (SF-12), and EQ-5D-5L (EuroQoL Group) questionnaires at baseline, and at three and nine months
3. Pain catastrophising and coping is assessed using the Hospital Anxiety and Depression Scale (HADS) and 8-point Arthritis Self-Efficacy Scale (ASES-8) at baseline, and at three and nine months
4. Resource use will be measured with a ‘Use of Hospital/Community Services’ questionnaire at baseline, and at three and nine months
5. Global change (overall pain and mobility/function) is measured using a 7-point Likert scale (much worse to much better), and data from WOMAC Parts 2 & 3 at three and nine months

Overall trial start date

27/01/2020

Overall trial end date

31/07/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Adults > 45 years
2. Chronic knee pain > 3 months and on most days of previous month
3. Knee pain during walking ≥4 on an 11-point numerical rating scale
4. Activity-related joint pain
5. Has a mobile phone, active email account, and computer with Internet access suitable for receiving/making Skype/Zoom video calls if required

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 90; UK Sample Size: 90

Participant exclusion criteria

1. Inflammatory arthritis including gout
2. Joint replacement in the study knee
3. An injection (e.g. steroid) into the study knee joint within the last month
4. An arthroscopy (i.e. keyhole surgery) of the study knee joint in the last three months
5. Enrolled in another research study involving an intervention for OA treatment or management
6. Unable to comply with the study protocol
7. Unable to understand written and spoken English

Recruitment start date

01/04/2020

Recruitment end date

31/12/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Leeds Community Healthcare NHS Trust
Stockdale House 8 Victoria Road
Leeds
LS6 1PF
United Kingdom

Sponsor information

Organisation

University of Leeds

Sponsor details

Woodhouse Lane
Leeds
LS2 9JT
United Kingdom
+44 (0)113 3434897
governance-ethics@leeds.ac.uk

Sponsor type

University/education

Website

http://www.leeds.ac.uk/

Funders

Funder type

Charity

Funder name

Versus Arthritis

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Institute for Health Research (NIHR) (UK)

Alternative name(s)

NIHR

Funding Body Type

unknown

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date

Intention to publish date

31/07/2023

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

29/01/2020: Trial’s existence confirmed by National Institute for Health Research (NIHR)