Cognitive Muscular Therapy for People Awaiting Knee Joint Replacement

NCT ID: NCT05801510

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2025-06-30

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

The treatment group will receive seven sessions of CMT over a 14 week period.

Group Type: EXPERIMENTAL

Cognitive Muscular Therapy for knee pain

Intervention Type: 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.

Interventions

Cognitive 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Salford

OTHER

Sponsor Role: lead

Responsible Party

Stephen Preece

Professor of Biomechanics and Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Salford

Manchester, Greater Manchester, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 34103040 (View on PubMed)

Related Links

http://hub.salford.ac.uk/cognitive-muscular-therapy/

Description of Cognitive Muscular Therapy

Other Identifiers

CMT-TKR-317409

Identifier Type: -

Identifier Source: org_study_id