Knee OsteoarthritisNCT05801510
Cognitive Muscular Therapy for People Awaiting Knee Joint Replacement
A study testing Cognitive Muscular Therapy for knee pain in people with Knee Osteoarthritis, run by University of Salford at 1 site in United Kingdom.
Trial summary
The primary aim will seek to understand whether Cognitive Muscular Therapy (CMT) could provide pain relief for people on a waiting list for joint replacement. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Cognitive Muscular Therapy for knee pain
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Above 40 years old
- Speak and understand English sufficient to read the information sheet and sign the consent form
- Ability to walk without any assistive device for at 20m (to ensure sufficient mobility to complete the intervention)
- Radiological diagnosis of knee OA
- On orthopaedic waiting but currently expected to wait at least 6 months for surgery (this will ensure that that the patient's care pathway is not affected)
Who cannot join
- Dementia or other major cognitive impairment.
- BMI >30 (as increased subcutaneous fat prevents collection of surface EMG signals)
- Previous knee replacement
- Any active systemic inflammatory disorders, such as rheumatoid arthritis with patient taking immunosuppressant drugs or steroids
- Any balance disorders which may increase the risk of a fall
- A history of rupture to the anterior cruciate ligament/ posterior cruciate ligament/ medial collateral ligament/ lateral collateral ligament
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- A diagnosis of psoriatic arthritis
- A diagnosis of post traumatic arthritis for example after a previous tibial plateau/ patella fracture
- A diagnosis of septic arthritis
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Salford
Manchester, Greater Manchester, M6 6PU
About this study
The primary aim will seek to understand whether Cognitive Muscular Therapy (CMT) could provide pain relief for people on a waiting list for joint replacement.
Read the detailed description
Knee osteoarthritis (KOA) is a chronic long-term condition that results in pain, disability and reduced quality of life. While current guidelines focus on the use of exercises to improve strength, there is clear evidence that people with knee osteoarthritis over-activate their muscles during functional tasks. Through NIHR funding the investigators have developed a new behavioural intervention for people with KOA- Cognitive Muscular Therapy (CMT). CMT aims to reduce overactivity of the knee muscles and change the way people react to pain. Importantly, muscle overactivity has been linked to increased pain, elevated joint loading and a more rapid rate of cartilage loss. Our pilot data suggests CMT can reduce knee osteoarthritis pain. Specifically, the investigatorsobserved a 69% reduction in pain in 11 patients who received six sessions of CMT. The investigators have subsequently trained 5 NHS physiotherapists to deliver CMT and observed them deliver the intervention to 12 patients. These patients reported average improvements in pain of 85% after 7 sessions.The proposed project will seek to understand whether CMT could provide pain relief for people on a waiting list for joint replacement. The first stage of the project will seek to understand patient's and clinicians perceptions of knee osteoarthritis. This insight will allow us to map changes to CMT which will make it suitable for people on a waiting list for knee replacement. Following modification of the intervention, the investigators plan to recruit 24 participants from knee replacement waiting lists in Manchester, UK. All participants will recieve the CMT treatment and this will consist of seven sessions of CMT over a 7 week period. All participants will complete questionnaires at baseline and at 10 weeks and will be offered an interview to understand their experiences.
- Conditions
- Knee Osteoarthritis
- Being tested
- Cognitive Muscular Therapy for knee pain
- Keywords
- Cognitive Muscular Therapy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Muscular Therapy for knee painBehavioural
Psychologically informed physiotherapy which uses biofeedback training to reduce muscle overactivity and improve postural control and also encourages people to change the way they react to pain.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | The treatment group will receive seven sessions of CMT over a 14 week period. Receives: Behavioral: Cognitive Muscular Therapy for knee pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain.
The extent of pain in the involved knee during five activities. Score 0-20 (0=no pain, 20=maximum pain)
Measured: Change from Baseline to 10 weeks
Secondary outcomes (1)
Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) (full score)
To assess pain and function in the involved knee. Score 0-96 (0=no pain/full function, 96=maximum pain/lowest function)
Measured: Change from Baseline to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start1 Mar 2023
- Primary completion30 Apr 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All partiticipants will receive seven sessions of CMT over a 7 week period. All participants will complete questionnaires at baseline and at 10 weeks
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salford
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Preece, University of Salford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801510
- Sponsor's protocol ID
- CMT-TKR-317409
- Status last verified
- Nov 2025
- First submitted
- 17 Mar 2023
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigtors may make the clinical data available through a document which will be linked to the final published journal paper
Publications
Preece SJ, Brookes N, Williams AE, Jones RK, Starbuck C, Jones A, Walsh NE. A new integrated behavioural intervention for knee osteoarthritis: development and pilot study. BMC Musculoskelet Disord. 2021 Jun 8;22(1):526. doi: 10.1186/s12891-021-04389-0.
PubMed 34103040
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Muscular Therapy for People Awaiting Knee Joint Replacement
- ClinicalTrials.gov ID
- NCT05801510
- Acronym / sponsor ID
- CMT-TKR-317409
- Conditions
- Knee Osteoarthritis
- Keywords
- Cognitive Muscular Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of SalfordUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 6 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim will seek to understand whether Cognitive Muscular Therapy (CMT) could provide pain relief for people on a waiting list for joint replacement.
Detailed description
Knee osteoarthritis (KOA) is a chronic long-term condition that results in pain, disability and reduced quality of life. While current guidelines focus on the use of exercises to improve strength, there is clear evidence that people with knee osteoarthritis over-activate their muscles during functional tasks. Through NIHR funding the investigators have developed a new behavioural intervention for people with KOA- Cognitive Muscular Therapy (CMT). CMT aims to reduce overactivity of the knee muscles and change the way people react to pain. Importantly, muscle overactivity has been linked to increased pain, elevated joint loading and a more rapid rate of cartilage loss. Our pilot data suggests CMT can reduce knee osteoarthritis pain. Specifically, the investigatorsobserved a 69% reduction in pain in 11 patients who received six sessions of CMT. The investigators have subsequently trained 5 NHS physiotherapists to deliver CMT and observed them deliver the intervention to 12 patients. These patients reported average improvements in pain of 85% after 7 sessions.The proposed project will seek to understand whether CMT could provide pain relief for people on a waiting list for joint replacement. The first stage of the project will seek to understand patient's and clinicians perceptions of knee osteoarthritis. This insight will allow us to map changes to CMT which will make it suitable for people on a waiting list for knee replacement. Following modification of the intervention, the investigators plan to recruit 24 participants from knee replacement waiting lists in Manchester, UK. All participants will recieve the CMT treatment and this will consist of seven sessions of CMT over a 7 week period. All participants will complete questionnaires at baseline and at 10 weeks and will be offered an interview to understand their experiences.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All partiticipants will receive seven sessions of CMT over a 7 week period. All participants will complete questionnaires at baseline and at 10 weeks
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Cognitive Muscular Therapy for knee painThe treatment group will receive seven sessions of CMT over a 14 week period. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Above 40 years old
- Speak and understand English sufficient to read the information sheet and sign the consent form
- Ability to walk without any assistive device for at 20m (to ensure sufficient mobility to complete the intervention)
- Radiological diagnosis of knee OA
- On orthopaedic waiting but currently expected to wait at least 6 months for surgery (this will ensure that that the patient's care pathway is not affected)
Key exclusion criteria (9 listed)
- Dementia or other major cognitive impairment.
- BMI >30 (as increased subcutaneous fat prevents collection of surface EMG signals)
- Previous knee replacement
- Any active systemic inflammatory disorders, such as rheumatoid arthritis with patient taking immunosuppressant drugs or steroids
- Any balance disorders which may increase the risk of a fall
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Muscular Therapy for knee painPsychologically informed physiotherapy which uses biofeedback training to reduce muscle overactivity and improve postural control and also encourages people to change the way they react to pain. | Behavioural | Treatment |
Primary outcome
Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain.
Time frame: Change from Baseline to 10 weeks
The extent of pain in the involved knee during five activities. Score 0-20 (0=no pain, 20=maximum pain)
1 secondary outcome
Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) (full score)
Time frame: Change from Baseline to 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Background: PubMed 34103040Preece SJ, Brookes N, Williams AE, Jones RK, Starbuck C, Jones A, Walsh NE. A new integrated behavioural intervention for knee osteoarthritis: development and pilot study. BMC Musculoskelet Disord. 2021 Jun 8;22(1):526. doi: 10.1186/s12891-021-04389-0.
- Description of Cognitive Muscular TherapyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. The investigtors may make the clinical data available through a document which will be linked to the final published journal paper
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Muscular Therapy for knee pain in people with Knee Osteoarthritis, run by University of Salford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain. (time frame: Change from Baseline to 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05801510, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.