Clinical trial NCT05801510: Cognitive Muscular Therapy for People Awaiting Knee Joint Replacement
Official title: Cognitive Muscular Therapy for People Awaiting Knee Joint Replacement
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Cognitive Muscular Therapy
Lead sponsor: University of Salford
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion:

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 any assistive device for at 20m (to ensure sufficient mobility to complete the intervention)
4. Radiological diagnosis of knee OA
5. 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:

1. Dementia or other major cognitive impairment.
2. BMI \>30 (as increased subcutaneous fat prevents collection of surface EMG signals)
3. Previous knee replacement
4. Any active systemic inflammatory disorders, such as rheumatoid arthritis with patient taking immunosuppressant drugs or steroids
5. Any balance disorders which may increase the risk of a fall
6. A history of rupture to the anterior cruciate ligament/ posterior cruciate ligament/ medial collateral ligament/ lateral collateral ligament
7. A diagnosis of psoriatic arthritis
8. A diagnosis of post traumatic arthritis for example after a previous tibial plateau/ patella fracture
9. A diagnosis of septic arthritis

Primary outcomes:
measure: Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain.
timeFrame: Change from Baseline to 10 weeks
Secondary outcomes:
measure: Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) (full score)
timeFrame: Change from Baseline to 10 weeks
Other outcomes:
measure: Change in Pain catastrophizing scale
timeFrame: Change from Baseline to 10 weeks
measure: Change in the EQ-5D-5L
timeFrame: Change from Baseline to 10 weeks
measure: Change in the Health resource utilisation - custom questionnaire
timeFrame: Change from Baseline to 10 weeks
measure: Change in the Oxford Knee Score
timeFrame: Change from Baseline to 10 weeks
measure: Change in the UCLA Activity Score
timeFrame: Change from Baseline to 10 weeks
measure: Change in the Arthritis Self Efficacy Scale (ASES)
timeFrame: Change from Baseline to 10 weeks
Locations:
city: Manchester
country: United Kingdom
facility: University of Salford
state: Greater Manchester
Study officials:
References:
citation: 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.