Development of a physiotherapist training course for a new intervention designed to reduce muscle overactivity in people with knee osteoarthritis
| ISRCTN | ISRCTN15448006 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15448006 |
| IRAS number | 298932 |
| Secondary identifying numbers | CPMS 50613, NIHR202203, IRAS 298932 |
- Submission date
- 16/02/2022
- Registration date
- 24/02/2022
- Last edited
- 27/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims:
We have developed a new physiotherapy treatment that may help people who do not experience benefit from muscle strengthening physiotherapy. This new treatment teaches patients how they can stop over-tightening their muscles when they walk or do other daily movements. It also teaches them to change the way they react to pain. Sensors are attached to the skin which enable patients to see their muscle patterns, both during movement and in response to pain. This muscle visualisation is supported with animated instructional videos to explain muscle and pain concepts. For more details on this new treatment see: https://hub.salford.ac.uk/cognitive-muscular-therapy/.
Before we can run a trial to understand the effectiveness of this new treatment, it is important that we test a training course, which has been designed to provide NHS physiotherapists with the skills they need to deliver the new treatment. To do this we will train 4 NHS physiotherapists and then observe them while they deliver the new treatment to patients with knee osteoarthritis. Both physiotherapists and patients will then attend a focus group workshop at will map appropriate modifications to the training course via qualitative research. Once we are happy with the training course, we will use it to train physiotherapists in a follow-on clinical trial.
Who can participate?
Patients over 40 years old, with knee osteoatrhritis
What does the study involve?
Patient with knee osteoarthritis who take part in the study will receive 6 sessions of the new treatment from an experienced NHS physiotherapists who has been recently trained to deliver the new treatment. They will then attend a focus group to discuss their experiences.
Physiotherapists who take part will receive both online and face to face training and will then deliver the new treatment under the observation of the research team. They will then attend a focus group to discuss their experiences.
What are the possible benefits and risks of participating?
Patient with knee osteoarthritis may experience clinical benefit from receiving the new treatment, such as reductions in pain. The treatment is very low risk.
Physiotherapists will develop new skills and become proficient at delivering the new treatment. There is minimal risk involved in delivering the new treatment
Where is the study run from?
University of Salford (UK)
When is the study starting and how long is it expected to run for?
November 2021 to October 2022
Who is funding the study?
National Institute for Health Research (NIHR) (UK).
Who is the main contact?
Dr Stephen Preece, s.preece@salford.ac.uk
Contact information
Scientific
Room PO34
The Brian Blatchford Building
The University of Salford
Manchester
M6 6PU
United Kingdom
 ORCID ID |
0000-0002-1126-1092 |
|---|---|
| n.brookes1@salford.ac.uk |
Principal Investigator
Health Sciences Research Centre
PO28 Blatchford Building
University of Salford
Salford
M6 6PU
United Kingdom
| ORCID ID |
0000-0002-2434-732X |
|---|---|
| Phone | +44 161 295 2273 |
| s.preece@salford.ac.uk |
Study information
| Study design | Interventional non randomized |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | 41174 PIS (patient) v4 14Oct2021.pdf |
| Scientific title | BEhaviour change to reduce Pain in Knee Osteoarthritis (BEPKO-2) - Training course development |
| Study acronym | BEPKO-2 |
| Study objectives | This is primarily a qualitative study to explore physiotherapists experiences of being trained and then delivering the new intervention. Although we will also collect and report clinical data from the patients who receive the intervention, we will not undertake any hypothesis testing. |
| Ethics approval(s) | Approved 12/10/2021, Leicester Central NHS REC (2 Redman Place, Stratford, London, E20 1JQ, UK; +44 207 104 8070; leicestercentral.rec@hra.nhs.uk), ref: 21/EM/0225 |
| Health condition(s) or problem(s) studied | Knee osteoarthritis |
| Intervention | This is aimed at testing and refining a training package for the new intervention that we have recently developed. More details on this intervention can be found at https://hub.salford.ac.uk/cognitive-muscular-therapy/. To test and refine the training package, we will recruit four NHS physiotherapists who have no previous experience with the new intervention along with 10 patients with KOA. The physiotherapists will be trained and will then deliver the intervention under observation from the research team. Each patients will receive 6 sessions of the new intervention, typically lasting 1 hour from one of the four NHS physiotherapists or from an expert physiotherapist. They will then be asked to attend a focus group workshop. Physiotherapists will also attend this workshop, during which we will map appropriate modifications to the training via qualitative research. |
| Intervention type | Other |
| Primary outcome measure | Osteoarthritis condition measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Baseline & 12 weeks |
| Secondary outcome measures | 1. Pain catastrophizing scale at Baseline & 12 weeks 2. Tampa scale of kinesiophobia at Baseline & 12 weeks |
| Overall study start date | 04/11/2021 |
| Completion date | 01/10/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 10; UK Sample Size: 10 |
| Total final enrolment | 20 |
| Key inclusion criteria | 1. Above 40 years old 2. Speak and understand English sufficient to read the information sheet and sign the consent form 3. Ability to walk without an assistive device for at least 100m (to ensure patients have sufficient mobility to be able to complete the intervention) 4. Clinical diagnosis of KOA according to ACR criteria 5. Pain for at least six months' duration |
| Key exclusion criteria | 1. Dementia or other major cognitive impairment 2. BMI >33 kg/m² (as increased subcutaneous fat prevents collection of surface EMG signals) 3. Lower limb arthroplasty 4. Any systemic inflammatory disorders, such as rheumatoid arthritis 5. Any balance disorders which may increase the risk of a fall 6. Not fully vaccinated against Covid-19 (for the safety of the physiotherapist and research staff) |
| Date of first enrolment | 23/02/2022 |
| Date of final enrolment | 01/07/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
The Brian Blatchford Building
Manchester
M66PU
United Kingdom
Eccles
Salford
M6 8HD
United Kingdom
Oxford Road
Manchester
M13 9WL
United Kingdom
Stockport
SK2 7JE
United Kingdom
Sponsor information
University/education
Allerton Building
University of Salford
Salford
M6 6PU
England
United Kingdom
| Phone | +44 161 295 2394 |
|---|---|
| v.halliwell@salford.ac.uk | |
| Website | http://hub.salford.ac.uk/health-and-society-research/ |
"ROR" |
https://ror.org/01tmqtf75 |
Funders
Funder type
Government
No information available
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Patient version 4 |
14/10/2021 | 17/02/2022 | No | Yes |
| Participant information sheet | Physio version 4 |
14/10/2021 | 17/02/2022 | No | Yes |
| Protocol file | version 1 | 24/08/2021 | 17/02/2022 | No | No |
| Abstract results | 01/03/2023 | 27/06/2023 | No | No | |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
27/06/2023: Publication reference added.
20/07/2022: The total final enrolment number has been added.
16/02/2022: Trial's existence confirmed by the National Institute for Health Research (NIHR) (UK).
