Cognitive Muscular Therapy for People Awaiting Knee Joint Replacement

NCT05801510 | Completed

• 1 other identifier: CMT-TKR-317409
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Cognitive Muscular Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) (full score)

  Change from Baseline to 10 weeks

Other Outcomes (6)

• Change in Pain catastrophizing scale

  Change from Baseline to 10 weeks

• Change in the EQ-5D-5L

  Change from Baseline to 10 weeks

• Change in the Health resource utilisation - custom questionnaire

  Change from Baseline to 10 weeks

Study Arms (1)

Treatment

EXPERIMENTAL

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

Behavioral: Cognitive Muscular Therapy for knee pain

Interventions

Cognitive Muscular Therapy for knee pain 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.

Treatment

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Salford: lead

Study Sites (1)

University of Salford

Manchester, Greater Manchester, M6 6PU, United Kingdom

Location

Related 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.

  PMID: 34103040 BACKGROUND

Related Links

• Description of Cognitive Muscular Therapy

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Biomechanics and Rehabilitation

Model Details: All partiticipants will receive seven sessions of CMT over a 7 week period. All participants will complete questionnaires at baseline and at 10 weeks

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: April 6, 2023
• Study Start: March 1, 2023
• Primary Completion: April 30, 2025
• Study Completion: June 30, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

GB (1)