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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Behavioral: Cognitive Muscular Therapy for knee pain

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M6 6PU
      • University of Salford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; The treatment group will receive seven sessions of CMT over a 14 week period.	Behavioral: 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain catastrophizing scale	Used to capture pain catastrophizing behaviours. Score 0-52 (0=no pain catastrophizing, 52=maximum pain catastrophizing)	Change from Baseline to 10 weeks
Change in the EQ-5D-5L	Captures the patient's self-rated health. Score 0-1 ( 0= death,1= perfect health)	Change from Baseline to 10 weeks
Change in the Health resource utilisation - custom questionnaire	To capture to use of health(care) resources	Change from Baseline to 10 weeks
Change in the Oxford Knee Score	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	Change from Baseline to 10 weeks
Change in the UCLA Activity Score	Used to capture activity levels. Score (1= low activity, 10= high activity)	Change from Baseline to 10 weeks
Change in the Arthritis Self Efficacy Scale (ASES)	Capture self-efficacy in people with arthritis. Score (8= low self efficacy, 80= high self efficacy)	Change from Baseline to 10 weeks

Collaborators and Investigators

• Sponsor: University of Salford

Publications and helpful links

General Publications

• 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.

Helpful Links

• Description of Cognitive Muscular Therapy

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): April 30, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: March 17, 2023
• First Submitted That Met QC Criteria: April 5, 2023
• First Posted (Actual): April 6, 2023

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Cognitive Muscular Therapy
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: CMT-TKR-317409

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The investigtors may make the clinical data available through a document which will be linked to the final published journal paper

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No