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Completed

NCT Number: NCT05801510

Cognitive Muscular Therapy for People Awaiting Knee Joint Replacement

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Salford

Manchester, Greater Manchester, M6 6PU, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Muscular Therapy for knee pain

Behavioral

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) (full score)

    Time frame: Change from Baseline to 10 weeks

    To assess pain and function in the involved knee. Score 0-96 (0=no pain/full function, 96=maximum pain/lowest function)

Other outcomes

  1. Change in Pain catastrophizing scale

    Time frame: Change from Baseline to 10 weeks

    Used to capture pain catastrophizing behaviours. Score 0-52 (0=no pain catastrophizing, 52=maximum pain catastrophizing)

  2. Change in the EQ-5D-5L

    Time frame: Change from Baseline to 10 weeks

    Captures the patient's self-rated health. Score 0-1 ( 0= death,1= perfect health)

  3. Change in the Health resource utilisation - custom questionnaire

    Time frame: Change from Baseline to 10 weeks

    To capture to use of health(care) resources

  4. Change in the Oxford Knee Score

    Time frame: Change from Baseline to 10 weeks

    The 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

  5. Change in the UCLA Activity Score

    Time frame: Change from Baseline to 10 weeks

    Used to capture activity levels. Score (1= low activity, 10= high activity)

  6. Change in the Arthritis Self Efficacy Scale (ASES)

    Time frame: Change from Baseline to 10 weeks

    Capture self-efficacy in people with arthritis. Score (8= low self efficacy, 80= high self efficacy)

Sponsors and collaborators

Lead sponsor

University of Salford

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 6, 2023
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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