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Cognitive Muscular Therapy for People Awaiting Knee Joint Replacement

Cognitive Muscular Therapy for People Awaiting Knee Joint Replacement

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05801510
Enrollment
36
Registered
2023-04-06
Start date
2023-03-01
Completion date
2025-06-30
Last updated
2025-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Keywords

Cognitive Muscular Therapy

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.

Interventions

BEHAVIORALCognitive Muscular Therapy for knee pain

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.

Sponsors

University of Salford
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

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

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain.Change from Baseline to 10 weeksThe extent of pain in the involved knee during five activities. Score 0-20 (0=no pain, 20=maximum pain)

Secondary

MeasureTime frameDescription
Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) (full score)Change from Baseline to 10 weeksTo assess pain and function in the involved knee. Score 0-96 (0=no pain/full function, 96=maximum pain/lowest function)

Other

MeasureTime frameDescription
Change in the Health resource utilisation - custom questionnaireChange from Baseline to 10 weeksTo capture to use of health(care) resources
Change in the Oxford Knee ScoreChange from Baseline to 10 weeksThe Oxford Knee Score (OKS) is a 12-item patient-reported PRO specifically designed and developed to assess function and pain. Score- (0= severe arthritis, 60=satisfactory joint function
Change in Pain catastrophizing scaleChange from Baseline to 10 weeksUsed to capture pain catastrophizing behaviours. Score 0-52 (0=no pain catastrophizing, 52=maximum pain catastrophizing)
Change in the Arthritis Self Efficacy Scale (ASES)Change from Baseline to 10 weeksCapture self-efficacy in people with arthritis. Score (8= low self efficacy, 80= high self efficacy)
Change in the UCLA Activity ScoreChange from Baseline to 10 weeksUsed to capture activity levels. Score (1= low activity, 10= high activity)
Change in the EQ-5D-5LChange from Baseline to 10 weeksCaptures the patient's self-rated health. Score 0-1 ( 0= death,1= perfect health)

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026