Centrally mediated pain after injury to the knee: A study of pain and function after knee fracture
| ISRCTN | ISRCTN12097923 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12097923 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 339920 |
| Protocol serial number | 24025, IRAS 339920 |
| Sponsor | University of Nottingham |
| Funder | NIHR Nottingham Biomedical Research Centre |
- Submission date
- 03/07/2024
- Registration date
- 11/07/2024
- Last edited
- 03/07/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Centrally mediated pain can affect people with knee arthritis. We are looking to see if it can occur in people who have a broken knee also. This will also let us know if there are other things that can affect pain after a broken knee such as mood or activity
Who can participate?
People aged 18 years or older, who have had a broken knee in the last 8 years can be involved in the study
What does the study involve?
The study will involve answering questionnaires and some tests of pain around your knee. These tests use a pressure-measuring device to measure pain threshold.
What are the possible benefits and risks of participating?
There are no direct benefits for participants but they will help us understand the disease more.
Where is the study run from?
This study is run by the Academic orthopaedic department at Nottingham University hospitals (UK)
When is the study starting and how long is it expected to run for?
February 2024 to July 2027
Who is funding the study?
NIHR Nottingham Biomedical Research Council (UK)
Who is the main contact?
Dr Chris Busby, christopher.busby@nhs.net
Contact information
Public, Scientific, Principal investigator
academic orthopedics, C floor, west block, queens medical center, derby road
Nottingham
NG72UH
United Kingdom
 ORCID ID |
0000-0002-2840-5558 |
|---|---|
| Phone | +44 115 924 9924 |
| christopher.busby@nhs.net |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational cross sectional study |
| Secondary study design | Cross sectional study |
| Study type | Participant information sheet |
| Scientific title | Centrally mediated pain following injury to the knee: a Cross-sectional study of pain and function following intra-articular knee injury |
| Study acronym | ExploreKNEE |
| Study objectives | To assess the prevalence of centrally mediated features in those who have suffered an intraarticular knee fracture. This will be achieved by evaluating if intra-articular knee injury has a link with centrally mediated pain and psychological distress. This may improve our knowledge about the relationship between knee injury, surgery, psychological distress and pain, which may help advance interventions to improve health outcomes. |
| Ethics approval(s) |
Not yet submitted |
| Health condition(s) or problem(s) studied | Prevalence of centrally mediated pain after intraarticular knee trauma |
| Intervention | Participants will be located from a database of trauma and will complete initial questionnaires remotely with a proportion being purposively sampled. These sampled participants will be assessed with further questionnaires and quantitative sensory testing. |
| Intervention type | Other |
| Primary outcome measure(s) |
Measured at a single time point: |
| Key secondary outcome measure(s) |
Measured at a single time point: |
| Completion date | 01/07/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 120 Years |
| Sex | All |
| Target sample size at registration | 80 |
| Key inclusion criteria | 1. Adult participants who attended Nottingham University Hospitals under the care of orthopaedic trauma and underwent treatment for intraarticular knee injuries from 2015-2023. 2. Must include one or more of the injury groups outlined below and include an intraarticular component as defined in AO Classification (2018) (1): 2.1. Patella fracture 2.2. Tibial plateau fracture 2.3. Distal femur fracture 3. Able to give informed consent. 4. Able to complete required questionnaires. |
| Key exclusion criteria | 1. Aged 17 years or under 2. Concomitant fracture involving another joint 3. Intra articular knee fracture that involves preceding prosthesis or implant. 4. Active malignancy 5. Pregnancy or breast feeding 6. People in custody of the police or incarcerated persons 7. Inability to read or write English. |
| Date of first enrolment | 01/08/2024 |
| Date of final enrolment | 01/08/2027 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Derby Road
Nottingham
NG7 2UH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated will be available on request from Chris Busby - Christopher.busby@nhs.net |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
03/07/2024: Trial's existence confirmed by NIHR Nottingham Biomedical Research Centre.
