Cognitive Muscular Therapy for People Awaiting Knee Joint Replacement

Study Overview
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Brief Summary
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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
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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 48 participants from two knee replacement waiting lists in Manchester, UK. The participants will be randomised into a treatment or a control group. The treatment group will receive seven sessions of CMT over a 7 week period. The control group will be advised to continue with their usual care. All participants will complete questionnaires at baseline and at 10 weeks. Treatment participants will be offered an interview to understand their experiences.

Official Title
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Cognitive Muscular Therapy for People Awaiting Knee Joint Replacement

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Behavioral: Cognitive Muscular Therapy for knee pain


Participation Criteria
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Eligibility Criteria
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Inclusion: 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) Exclusion: 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 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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The participants will be randomised into a treatment or a control group. The treatment group will receive seven sessions of CMT over a 7 week period. The control group will be advised to continue with their usual care. All participants will complete questionnaires at baseline and at 10 weeks
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>The treatment group will receive seven sessions of CMT over a 14 week period. | Behavioral: Cognitive Muscular Therapy for knee pain<br>* 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.<br>|
| No Intervention: Control<br>The control group will be advised to continue with their usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Change from Baseline to 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Change from Baseline to 10 weeks |