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CompletedNCT05801510Updated Dec 2, 2025

Cognitive Muscular Therapy for People Awaiting Knee Joint Replacement

An interventional study of Cognitive Muscular Therapy for knee pain in Knee Osteoarthritis, sponsored by University of Salford. Completed at 1 site in United Kingdom. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-12-02.

Sponsored by University of Salford · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Not applicable
Ages
40 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Knee Osteoarthritis

Keywords

  • Cognitive Muscular Therapy
03

In context

Osteoarthritis, Knee

3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.

This study's enrollment of 36 is below the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

University of Salford is the lead sponsor of 27 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  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 criteria

Exclusion:

  1. Dementia or other major cognitive impairment.
  2. >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 drugs or
  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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    Treatment

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

    Behavioral: Cognitive Muscular Therapy for knee pain

Interventions

  • BehavioralCognitive 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.

06

What researchers measure

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)

    Time frame: Change from Baseline to 10 weeks

Secondary outcomes

  1. 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)

    Time frame: Change from Baseline to 10 weeks

Other outcomes

  1. Change in Pain catastrophizing scale

    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

  2. Change in the EQ-5D-5L

    Captures the patient's self-rated health. Score 0-1 ( 0= death,1= perfect health)

    Time frame: Change from Baseline to 10 weeks

  3. Change in the Health resource utilisation - custom questionnaire

    To capture to use of health(care) resources

    Time frame: Change from Baseline to 10 weeks

  4. 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

    Time frame: Change from Baseline to 10 weeks

  5. Change in the UCLA Activity Score

    Used to capture activity levels. Score (1= low activity, 10= high activity)

    Time frame: Change from Baseline to 10 weeks

  6. Change in the Arthritis Self Efficacy Scale (ASES)

    Capture self-efficacy in people with arthritis. Score (8= low self efficacy, 80= high self efficacy)

    Time frame: Change from Baseline to 10 weeks

07

Study locations

1 site
  • University of Salford
    Manchester, Greater Manchester M6 6PU, United Kingdom
08

References and documents

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. PubMed 34103040 ↗

Individual participant data

Plan to share: Undecided — The investigtors may make the clinical data available through a document which will be linked to the final published journal paper

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2023 to primary completion in Apr 2025, 25 months.

Of 1,111 non-industry interventional studies with no phase under Osteoarthritis, Knee, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's 25 months is above that.

Counting every sponsor, half of 1,251 studies reached it within 18 months; a quarter within 8 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 17, 2023
First posted
Apr 6, 2023
StartActual
Mar 1, 2023
Primary completionActual
Apr 30, 2025
CompletionActual
Jun 30, 2025
Last update
Dec 2, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05801510
Lead sponsor
University of Salford
Responsible party
Stephen Preece (Professor of Biomechanics and Rehabilitation, University of Salford) — Principal investigator
First posted
Apr 6, 2023
Start date
Mar 1, 2023
Primary completion
Apr 30, 2025
Completion
Jun 30, 2025
Last update
Dec 2, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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