Cognitive Muscular Therapy for People Awaiting Knee Joint Replacement

Knee Osteoarthritis Clinical Trial

Official title:

Cognitive Muscular Therapy for People Awaiting Knee Joint Replacement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05801510
• Other study ID #: CMT-TKR-317409
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: October 2023
• Source: University of Salford
• Contact: Stephen J Preece, PhD
• Phone: 44 161 295 2273
• Email: s.preece[@]salford.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 48 participants from two knee replacement waiting lists in Manchester, UK. The participants will be randomised into a treatment or a control group. The treatment group will receive seven sessions of CMT over a 7 week period. The control group will be advised to continue with their usual care. All participants will complete questionnaires at baseline and at 10 weeks. Treatment participants will be offered an interview to understand their experiences.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: October 31, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	University of Salford	Manchester	Greater Manchester

Sponsors (1)

Lead Sponsor	Collaborator
University of Salford

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. Erratum In: BMC Musculoskelet Disord. 2022 Jan 25;23(1):83. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Change in Tampa scale of kinesiophobia	Used to capture kinesiophobia behaviours. Score 17-68 (0=no kinesiophobia, 52=maximum kinesiophobia)	Change from Baseline to 10 weeks
Other	Change in the Generalised Anxiety and Depression Scale (GAD-7)	Used to measure anxiety and depression. Score 0-21 (0=normal, 21= severe anxiety)	Change from Baseline to 10 weeks
Other	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
Other	Change in the Work productivity and activity impairment (WPAI) questionnaire	Measures impairments in both paid work and unpaid work, absenteeism and presenteeism	Change from Baseline to 10 weeks
Other	Change in the Health resource utilisation - custom questionnaire	To capture to use of health(care) resources	Change from Baseline to 10 weeks
Other	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
Other	Change in the UCLA Activity Score	Used to capture activity levels. Score (1= low activity, 10= high activity)	Change from Baseline to 10 weeks
Other	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
Other	Change in the Knee Osteoarthritis Fears and Beliefs Questionnaire (KOFBeQ)	Assesses fears and beliefs of patients with knee OA. Score (0= high fear, 11= low fear)	Change from Baseline to 10 weeks
Primary	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	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

External Links

•   Description of Cognitive Muscular Therapy