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Cognitive Muscular Therapy for People Awaiting Knee Joint Replacement

Primary Purpose

Knee Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Cognitive Muscular Therapy for knee pain
Sponsored by
University of Salford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of SalfordRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment

Control

Arm Description

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

The control group will be advised to continue with their usual care.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)

Full Information

First Posted
March 17, 2023
Last Updated
October 13, 2023
Sponsor
University of Salford
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1. Study Identification

Unique Protocol Identification Number
NCT05801510
Brief Title
Cognitive Muscular Therapy for People Awaiting Knee Joint Replacement
Official Title
Cognitive Muscular Therapy for People Awaiting Knee Joint Replacement
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Salford

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
The treatment group will receive seven sessions of CMT over a 14 week period.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group will be advised to continue with their usual care.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Muscular Therapy for knee pain
Intervention Description
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 Outcome Measure Information:
Title
Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain.
Description
The extent of pain in the involved knee during five activities. Score 0-20 (0=no pain, 20=maximum pain)
Time Frame
Change from Baseline to 10 weeks
Secondary Outcome Measure Information:
Title
Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) (full score)
Description
To assess pain and function in the involved knee. Score 0-96 (0=no pain/full function, 96=maximum pain/lowest function)
Time Frame
Change from Baseline to 10 weeks
Other Pre-specified Outcome Measures:
Title
Change in Pain catastrophizing scale
Description
Used to capture pain catastrophizing behaviours. Score 0-52 (0=no pain catastrophizing, 52=maximum pain catastrophizing)
Time Frame
Change from Baseline to 10 weeks
Title
Change in Tampa scale of kinesiophobia
Description
Used to capture kinesiophobia behaviours. Score 17-68 (0=no kinesiophobia, 52=maximum kinesiophobia)
Time Frame
Change from Baseline to 10 weeks
Title
Change in the Generalised Anxiety and Depression Scale (GAD-7)
Description
Used to measure anxiety and depression. Score 0-21 (0=normal, 21= severe anxiety)
Time Frame
Change from Baseline to 10 weeks
Title
Change in the EQ-5D-5L
Description
Captures the patient's self-rated health. Score 0-1 ( 0= death,1= perfect health)
Time Frame
Change from Baseline to 10 weeks
Title
Change in the Work productivity and activity impairment (WPAI) questionnaire
Description
Measures impairments in both paid work and unpaid work, absenteeism and presenteeism
Time Frame
Change from Baseline to 10 weeks
Title
Change in the Health resource utilisation - custom questionnaire
Description
To capture to use of health(care) resources
Time Frame
Change from Baseline to 10 weeks
Title
Change in the Oxford Knee Score
Description
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
Time Frame
Change from Baseline to 10 weeks
Title
Change in the UCLA Activity Score
Description
Used to capture activity levels. Score (1= low activity, 10= high activity)
Time Frame
Change from Baseline to 10 weeks
Title
Change in the Arthritis Self Efficacy Scale (ASES)
Description
Capture self-efficacy in people with arthritis. Score (8= low self efficacy, 80= high self efficacy)
Time Frame
Change from Baseline to 10 weeks
Title
Change in the Knee Osteoarthritis Fears and Beliefs Questionnaire (KOFBeQ)
Description
Assesses fears and beliefs of patients with knee OA. Score (0= high fear, 11= low fear)
Time Frame
Change from Baseline to 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen J Preece, PhD
Phone
44 161 295 2273
Ext
52273
Email
s.preece@salford.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Nathan Brookes, BSc
Phone
44 161 295 2273
Ext
52273
Email
n.brookes1@salford.ac.uk
Facility Information:
Facility Name
University of Salford
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M6 6PU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer L Parker, PhD
Phone
07790 912929
Email
j.parker17@salford.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The investigtors may make the clinical data available through a document which will be linked to the final published journal paper
Citations:
PubMed Identifier
34103040
Citation
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.
Results Reference
background
Links:
URL
http://hub.salford.ac.uk/cognitive-muscular-therapy/
Description
Description of Cognitive Muscular Therapy

Learn more about this trial

Cognitive Muscular Therapy for People Awaiting Knee Joint Replacement

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