Cognitive Muscular Therapy for People Awaiting Knee Joint Replacement

Not Applicable

Recruiting

• Conditions: Knee Osteoarthritis
• Interventions: Behavioral: Cognitive Muscular Therapy for knee pain

• Registration Number: NCT05801510
• Lead Sponsor: University of Salford

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.

Study Timeline

• Study Start: 2023-03-01
• Study First Submitted: 2023-03-17
• Study First Submitted QC: 2023-04-05
• Study First Posted: 2023-04-06
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-26
• Last Update Posted: 2024-09-30
• Primary Completion: 2025-04-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Cognitive Muscular Therapy for knee pain	The treatment group will receive seven sessions of CMT over a 14 week period.

Primary Outcome Measures

Name	Time	Method
Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain.	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 Outcome Measures

Name	Time	Method
Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) (full score)	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)

Trial Locations

Locations (1)

University of Salford; 🇬🇧 Manchester, Greater Manchester, United Kingdom