Plain English Summary
Background and study aims
Osteoarthritis is a condition that causes joints to become painful and stiff.
Research has demonstrated that individuals with knee osteoarthritis stand, walk and perform other activities with increased co-contraction (simultaneous activation) of the knee muscles: hamstrings and quadriceps. These muscle patterns will increase the stress on the knee joint and may speed up the progression of knee osteoarthritis. Importantly, despite the association between co-contraction and knee osteoarthritis, there are no physiotherapy approaches which aim to improve muscle coordination and reduce co-contraction in patients with this condition.
The aim of this study is to create a new biofeedback intervention using electromyography (EMG) technology. With EMG, small skin-mounted electrodes are used to measure electrical activity produced during muscle contraction. Although EMG technology has been used to develop biofeedback applications for conditions such as neck pain, a biofeedback application for knee osteoarthritis does not exist.
Following preliminary consultation with patients and physiotherapists, the researchers mapped out key components of a digital physiotherapy intervention for people with knee osteoarthritis. During this study, they aim to develop the different intervention components through an iterative approach, involving user consultation. The primary components of the intervention are:
1. Introductory video sequence – which explains key concepts and is watched before the first contact session
2. Physiotherapy assessment & patient report – used to map out and explain muscle tension patterns and abnormal muscle coordination
3. Tension release procedures – used to teach reorganisation of postural muscle activity in standing
4. Muscle coordination procedures – used to improve muscle coordination during functional tasks
5. Biofeedback software – used to assess muscle patterns and provide feedback to facilitate (3) and (4) above
By refining the intervention through continued consultation with people who have knee osteoarthritis, the aim is to develop a new intervention which can be delivered by physiotherapists. As part of this study, the researchers also plan to record reductions in pain so that they can develop an understanding of how effective the new treatment might be.
Who can participate?
Patients aged 40 - 80 years with knee osteoarthritis
What does the study involve?
All participants receive the intervention, typically attending for 6 face-to-face physiotherapy sessions with specific procedures to practice outside of contact sessions. After each session, participants are asked for their opinion of the treatment and for suggestions of how it could be improved.
What are the possible benefits and risks of participating?
The aim of the treatment is the reduce muscle tension and to improve knee pain. Participants may experience reductions in their knee pain after taking part. There should be no side effects from the treatment.
Where is the study run from?
The lead centre is the University of Salford, Manchester, UK. There will be four other local NHS trusts: Salford, Central Manchester, Stockport and Fairfield General Hospital Bury.
When is the study starting and how long is it expected to run for?
May 2018 to October 2020
Who is funding the study?
1. National Institute for Health Research (UK)
2. University of Salford (UK)
Who is the main contact?
Dr Stephen Preece
s.preece@salford.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Stephen Preece
ORCID ID
http://orcid.org/0000-0002-2434-732X
Contact details
Health Sciences Research Centre
PO28 Blatchford Building
University of Salford
Salford
M6 6PU
United Kingdom
+44 (0)161 295 2273
s.preece@salford.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
v3, HLRB25, CPMS 38156, IRAS 232749
Study information
Scientific title
The feasibility of using Biofeedback to rEduce Pain in people with Knee Osteoarthritis
Acronym
BEPKO
Study hypothesis
There was no formal hypothesis as this study aimed to develop a new intervention through successive testing and iteration.
Ethics approval
Approved 18/05/2018, North West - Greater Manchester East Research Ethics Committee (3rd Floor, Barlow House, 4 Minshull Street, Manchester, M1 3DZ, UK; Tel: +44 (0)207 104 8009; Email: nrescommittee.northwest-gmeast@nhs.net), REC ref: 18/NW/0282
Study design
Intervention development study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
See additional files
Condition
Knee osteoarthritis
Intervention
The intervention development study will involve a physiotherapist (employed on the project) delivering successive iterations of the intervention to individual patients with KOA. One of the key principles of the intervention is that patients will only be able to reduce muscle activity in their knee muscles if they become aware of, and are able to change, more general patterns of muscle tension throughout their whole body. By employing an artist/animator on the project, the researchers propose to develop a range of instructional animations which will convey the idea of whole-body patterns of muscle tension. During the intervention testing session, the physiotherapist will work with the patient to explain (using the animations) their individual patterns of muscle tension. Then, using the biofeedback software, the therapist will then teach the patient to downregulate the activation of their hamstrings, quadriceps and gastrocnemius across different tasks. These tasks will gradually increase in difficulty until full walking is achieved. The researchers refer to these tasks as the incremental training activities (ITAs). Following each intervention session, patients will be asked to provide feedback on their perception of the three main components of the intervention: the biofeedback software, the incremental training activities and the instructional animations. They will also be asked for their opinion on how these supervised sessions could be continued at home (home practice component) and also on an introductory video which the researchers will develop to explain the key ideas of the intervention.
The researchers anticipate each session would last 1-2 hours and envisage delivering between 1-10 sessions depending on
the stage of the project. In addition to obtaining patient feedback after each individual session, they propose to carry out focus groups and individual interviews at three timepoints (Month 4, Month 11 and Month 16) to fully explore patient’s experiences and perceptions of the intervention. The data gathered from the focus groups/interviews, along with the individual feedback, will be used to improve the different components of the intervention. Specifically, the researchers will:
1. Improve the usability of the biofeedback software
2. Fully define an appropriate set of incremental training activities
3. Develop a library of easy-to-understand instructional animations which can be used with the different incremental training activities
4. Map out a home practice component
5. Develop an easy-to-understand introductory video which would be watched before the first intervention session
Through the procedures described above, the researchers will produce a fully defined intervention which will be formally evaluated in a follow-up study. Note that this project will not incorporate any formal evaluation of the intervention.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Pain measured using the knee injury and osteoarthritis outcome score (KOOS) at baseline and immediately after the end of the intervention (typically 6 sessions over 12 weeks)
Secondary outcome measures
There are no secondary outcome measures
Overall trial start date
05/05/2018
Overall trial end date
31/10/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Knee OA participants will be included if they have a clinical diagnosis of knee OA, using the American College of Rheumatology (ACR) criteria. This is given as clinical presentation of pain in the knee and at least three of the following:
1. Age 40-80 years (note those under 50 must have a confirmed radiological diagnosis of knee OA)
2. Stiffness < 30 minutes per day
3. Crepitus
4. Bony tenderness
5. Bony enlargement
6. Palpable warmth
Full inclusion criteria are given below:
1. Age range of 18-80 (upper age limit to exclude people who may have limited mobility)
2. Ability to stand and walk independently
3. Speak and understand English to read the information sheet and sign consent form
4. Ability to walk without any assistive for at least 100 m (this is 100 m is not representative of the real demand of the testing, but we want to be sure participants will not get fatigued during the testing)
5. Clinical diagnosis of knee OA according to American College of Rheumatology (ACR) [37], see above, only for subjects with knee OA
6. Pain for at least 6 months' duration only for subjects with knee OA
7. Pain or difficulty in rising from sitting and/or climbing stairs, only for subjects with knee OA
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
75
Participant exclusion criteria
1. Complex pain conditions such as diabetic neuropathic pain, fibromyalgia
2. Dementia or other major cognitive impairment
3. Have had previous surgery to the lower limb
4. BMI >35 since it is not possible to obtain EMG muscle measurements on individuals with excess adipose tissue
5. Lower limb arthroplasty
6. Any systemic inflammatory disorders, such as rheumatoid arthritis
7. Any balance disorders which may increase the risk of a fall
Recruitment start date
01/06/2018
Recruitment end date
01/10/2020
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Salford Royal NHS Foundation Trust
Stott Lane
Eccles
Salford
M6 8HD
United Kingdom
Trial participating centre
Fairfield General Hospital
Rochdale Old Rd, Bury
Manchester
BL9 7TD
United Kingdom
Trial participating centre
Kingsgate House
First Floor
Wellington Road North
Stockport
Manchester
SK4 1LW
United Kingdom
Trial participating centre
University of Salford
Frederick Road
Salford
M6 6PU
United Kingdom
Sponsor information
Organisation
University of Salford
Sponsor details
Blatchford Building
Salford
M6 6PU
United Kingdom
+44 (0)161 295 5000
s.preece@salford.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Funder name
University of Salford Manchester
Alternative name(s)
University of Salford, University of Salford, Manchester, USM
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
No additional documents will be made available as this is an intervention development study. The researchers aim to publish one intervention development paper in the journal BMC Musculoskeletal Disorders.
IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
01/12/2020
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN51913166_PIS_v3_24Aug2018.pdf uploaded 24/02/2020