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
IRAS number	339920
Secondary identifying numbers	24025, IRAS 339920

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

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

Dr Chris Busby
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
Email	christopher.busby@nhs.net

Study information

Study design	Observational cross sectional study
Primary study design	Observational
Secondary study design	Cross sectional study
Study setting(s)	Hospital, University/medical school/dental school
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details to request a patient 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 hypothesis	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
Condition	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	Measured at a single time point: 1. Features of centrally mediated pain measured using quantitative sensory testing (conditioned pain modulation, pressure algometry) 2. Central Aspects of Pain in the Knee Questionnaire (CAP-Knee) 3. Measures of Central sensitisation and neuropathic pain (Central sensitisation inventory (CSI), PainDETECT questionnaires) 4. Numerical Rating Scale (NRS) 5. Brief pain inventory (BPI)
Secondary outcome measures	Measured at a single time point: 1. Features of psychological distress measured using Hospital anxiety and depression scale (HADS) 2. Knee Function after trauma, measured using the The Knee Injury and Osteoarthritis Outcome Score (KOOS) and EQ-5D-5L
Overall study start date	10/02/2024
Overall study end date	01/07/2028

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	120 Years
Sex	Both
Target number of participants	80
Participant 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.
Participant 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.
Recruitment start date	01/08/2024
Recruitment end date	01/08/2027

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Nottingham University Hospitals NHS Trust - Queen's Medical Centre Campus

Nottingham University Hospital
Derby Road
Nottingham
NG7 2UH
United Kingdom

Sponsor information

University of Nottingham
University/education

Research and Innovation, E-Floor Yang Fujia Building
Nottingham
NG7 2RD
England
United Kingdom

Phone	+44 115 951 5151
Email	sponsor@nottingham.ac.uk
Website	http://www.nottingham.ac.uk/
"ROR"	https://ror.org/01ee9ar58

Funders

Funder type

Government

NIHR Nottingham Biomedical Research Centre
Government organisation / Research institutes and centers

Alternative name(s): Nottingham Biomedical Research Centre, Nottingham Biomedical Research Centre - NIHR, NIHR Nottingham BRC, BRC, NIHR NBRC
Location: United Kingdom

Results and Publications

Intention to publish date	01/08/2028
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Results will be presented at local and international meetings and in appropriate peer-reviewed journals. Funding bodies and contributors will be acknowledged in publications arising from the study. The results may also form part of a PhD thesis
IPD sharing plan	The datasets generated will be available on request from Chris Busby - Christopher.busby@nhs.net

Editorial Notes

03/07/2024: Trial's existence confirmed by NIHR Nottingham Biomedical Research Centre.