A multi-centre feasibility study to understand the benefits of a new intervention designed to reduce muscle overactivity in people with knee osteoarthritis
| ISRCTN | ISRCTN25291958 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25291958 |
| IRAS number | 306258 |
| Secondary identifying numbers | CPMS 51023, IRAS 306258 |
- Submission date
- 08/04/2022
- Registration date
- 27/04/2022
- Last edited
- 13/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
People with knee osteoarthritis (KOA) often have physiotherapy which focuses on ways to strengthen the muscles in the leg. Unfortunately, for about 40% of people, this type of physiotherapy does not reduce their pain. This may be because people with KOA often over-tense their knee muscles during daily activities. In this situation, traditional exercise will not help to reduce their pain.
Researchers 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.
In a previous study, knee pain was reduced by an average of 69% following our treatment. It should therefore be possible to reduce pain in patients who do not respond to traditional muscle-strengthening. The researchers will ask 90 patients to take part who have previously received muscle strengthening for KOA but who have not experienced any improvement. They have already worked with patients and physiotherapists to develop the new treatment. The researchers will continue to do so in this study by asking their views on our training materials, how they experience the new treatment, and the best ways of letting people know about the results of the study. The information from this study will show whether the new treatment is acceptable for people who do not respond to muscle strengthening. If so, the researchers hope in the future to do a larger study which will show how helpful the intervention is at improving pain. This could change the way KOA is managed within the NHS, providing an alternative treatment for people who do not respond to muscle strengthening. This could help patients and also save the NHS money as it could stop patients needing to be referred for a knee replacement operation.
Who can participate?
1. Patients over 40 years old with a diagnosis of knee osteoarthritis
2. Physiotherapists working at the grade of a band 6 and above
What does the study involve?
Patients will be put into two groups by chance, like tossing a coin: half will get the new behavioural treatment, and the other half will get their usual care from their physiotherapist and other healthcare professionals. The researchers will ask participants to tell them about their pain, quality of life and how they manage their own pain before they start the study, at 20 weeks and at 8 months. They will also interview patients and physiotherapists to understand their experiences of receiving/delivering the new treatment. Physiotherapists who take part will receive both online and face to face training and will then deliver the new treatment with support from the research team. The physiotherapists will be invited to an interview to understand their experiences of delivering the new treatment.
What are the possible benefits and risks of participating?
Patients who get the new treatment may experience reductions in pain. The treatment is very low risk. Physiotherapists will develop new treatment skills. 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?
December 2021 to April 2024
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
| Phone | +44 (0)161 205 2273 |
|---|---|
| n.brookes1@salford.ac.uk |
Scientific
Research Centre Director
Health Sciences PO28
The Brian Blatchford Building
The University of Salford
Salford
M6 6PUT
United Kingdom
 ORCID ID |
0000-0002-2434-732X |
|---|---|
| Phone | +44 (0) 0161 295 2273 |
| s.preece@salford.ac.uk |
Study information
| Study design | Randomized; Both; Design type: Treatment, Rehabilitation, Validation of investigation /therapeutic procedures |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | 41532_PIS_feasibility study interview (physiotherapist)_V1_16Dec21.pdf |
| Scientific title | BEhaviour change to reduce Pain in Knee Osteoarthritis (BEPKO-2) - a feasibility study |
| Study acronym | BEPKO-2 |
| Study objectives | This is a feasibility study so there will be no formal hypothesis testing. However, the study will provide data which will inform the design of a future trial which will test whether Cognitive Muscular Therapy reduces the pain associated with knee osteoarthritis. |
| Ethics approval(s) | Approved 06/01/2022, West Midlands - Solihull Research Ethics Committee (Equinox House, City Link, Nottingham, NG2 4LA, UK; +44 (0)207 104 8310; solihull.rec@hra.nhs.uk), ref: 21/WM/0255 |
| Health condition(s) or problem(s) studied | Knee osteoarthritis |
| Intervention | Researchers 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/. Physiotherapists: The researchers plan to recruit six band 6 physiotherapists to deliver the CMT intervention. Each physiotherapist who participates in the trial will receive training to deliver the CMT intervention via an initial online module (approximately eight hours), followed by two face-to-face one-day workshops. The physiotherapist will be expected to keep a reflective diary and to use an online platform to share experiences of the training and the intervention. Further support from the lead physiotherapist or another suitably trained physiotherapist will be offered throughout the study if required. Participants: The researchers will aim to recruit 90 participants to the study. Once recruited the participants will be randomised into one of two groups. Participants in the control arm will receive advice to continue exercise in line with the ESCAPE programme and to access usual care. Participants in the intervention arm will receive six sessions of cognitive muscular therapy by a suitably trained physiotherapist, delivered over a period of 12 weeks. In addition to these intervention sessions, intervention arm participants will attend two Electromyography (EMG) data collection sessions. In these sessions, small sensors placed on the skin will be used to measure muscle activity during a variety of tasks. These will take place, the week prior to their first treatment and the week following their final treatment. The participants will be asked to perform a set of everyday activities, including walking, standing up from a chair, stepping down and balancing on one leg whilst EMG data is recorded. The researchers will also collect the same muscle outcome data, at the University of Salford, from a subset of 10 participants in the control arm. In addition, participants in the control group will be instructed to perform some maximal effort contractions, which involve standing on tiptoes, and flexing/extending the knee against a fixed resistance. The researchers will also assess hip flexibility, collect some simple balance measurements using a force platform and collect postural and breathing measurements using a 3D camera. It is possible that some patients who are included in the intervention arm will be continuing to practice ESCAPE strengthening exercises. Participants will therefore be advised to stop these exercises for the duration of the trial but to continue with low-intensity aerobic exercise. To monitor intervention fidelity, the researchers will capture video recordings of approximately 15-20 of the physiotherapy sessions from all six NHS physiotherapists at different stages of the intervention cycle. These recordings will only be collected from participants who have consented and will not be shared outside the research teams. Once they have been analysed, they will be permanently deleted. After completing the intervention the researchers will interview a subset of participants in the treatment arm and patients in the control arm to understand experiences of being involved in the trial. They will purposively select (through pain outcomes) 15 participants from the intervention arm who demonstrate a range of clinical responses. They will ensure that, with the sample of 15 participants, they include at least two to three who have decided to drop out before completing the full six intervention sessions, to gain insight into reasons for non-adherence. The researchers will interview all six NHS physiotherapists after intervention delivery is complete to understand their experience of delivering the intervention. These interviews will take place either face to face or over the phone/skype. The researchers will also ask each physiotherapist to complete the Normalisation Process Theory Survey. |
| Intervention type | Behavioural |
| Primary outcome measure | Pain and function measured using the WOMAC questionnaire at baseline, 20 weeks and 8 months |
| Secondary outcome measures | 1. Pain catastrophisation measured using the Pain catastrophizing scale at baseline, 20 weeks and 8 months 2. Kinesiophobia measured using the Tampa scale of kinesiophobia at baseline, 20 weeks and 8 months 3. Anxiety and depression measured using the Generalised Anxiety and Depression Scale at baseline, 20 weeks and 8 months 4. Health-related quality of life measured using the EQ-5D-5L at baseline, 20 weeks and 8 months 5. Health resource utilisation measured using a custom questionnaire at baseline, 20 weeks and 8 months 6. Work productivity and activity impairment measured using the work productivity and activity impairment (WPAI) questionnaire at baseline, 20 weeks and 8 months |
| Overall study start date | 01/12/2021 |
| Completion date | 28/04/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 40 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 90; UK Sample Size: 90 |
| Total final enrolment | 84 |
| 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 100 m (to ensure patients have sufficient mobility to be able to complete the intervention) 4. Clinical diagnosis of KOA according to American College of Rheumatology (ACR) criteria 5. Pain for at least 6 months' duration 6. Attended a minimum of six (of 10/12) ESCAPE pain classes 7. Improvement in KOOS following ESCAPE <15% from their pre-ESCAPE condition |
| Key exclusion criteria | 1. Dementia or other major cognitive impairment 2. BMI >33 kg/m² (as increased subcutaneous fat prevents the 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 | 16/05/2022 |
| Date of final enrolment | 11/08/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
The Brian Blatchford Building
Manchester
M6 6PU
United Kingdom
Eccles
Salford
M6 8HD
United Kingdom
Platt Lane
Fallowfield
Manchester
M14 7FB
United Kingdom
15 High Park Street
Liverpool
L8 8DX
United Kingdom
Speedwell Road
Speedwell
Bristol
BS15 1NU
United Kingdom
Sponsor information
University/education
c/o Victoria Halliwell
Allerton Building
Salford
M6 6PU
England
United Kingdom
| Phone | +44 (0)161 295 2394 |
|---|---|
| v.halliwell@salford.ac.uk | |
| Website | http://www.salford.ac.uk/ |
"ROR" |
https://ror.org/01tmqtf75 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| 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 data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version Feasibility study interview (physiotherapist) | 16/12/2021 | 26/04/2022 | No | Yes |
| Participant information sheet | Collection of ESCAPE outcomes version 1 |
10/02/2022 | 26/04/2022 | No | Yes |
| Participant information sheet | Feasibility study (patient) version 5 |
05/04/2022 | 26/04/2022 | No | Yes |
| Participant information sheet | Feasibility study (physiotherapist) version 3 |
16/12/2021 | 26/04/2022 | No | Yes |
| Protocol file | version 4 | 05/04/2022 | 26/04/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Basic results | 13/05/2025 | No | No |
Additional files
- 41532_PIS_collection of ESCAPE outcomes_V1_10Feb22.pdf
- Collection of ESCAPE outcomes
- 41532_PIS_feasibility study (patient)_V5_05Apr22.pdf
- Feasibility study (patient)
- 41532_PIS_feasibility study (physiotherapist)_V3_16Dec21.pdf
- Feasibility study (physiotherapist)
- 41532_PIS_feasibility study interview (physiotherapist)_V1_16Dec21.pdf
- 41532_PROTOCOL_V4_05Apr22.pdf
- ISRCTN25291958_BasicResults.pdf
Editorial Notes
05/04/2024: The intention to publish date was changed from 28/04/2024 to 31/12/2024.
16/08/2023: The total final enrolment was added.
09/06/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 21/06/2023 to 11/08/2023.
2. The overall end date was changed from 30/11/2023 to 28/04/2024.
3. The intention to publish date was changed from 30/11/2024 to 28/04/2024.
4. The plain English summary was updated to reflect these changes.
08/04/2022: Trial's existence confirmed by the NIHR.
