Ignite Creation Date:
2024-05-06 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03132064
Status:
SUSPENDED
Last Update Posted:
2020-05-27
First Post:
2017-04-11
Brief Title:
The Association Between Pre-operative Pain Psychology and Hypersensitivity With Poor Functional Outcome After Knee Replacement
Sponsor:
University of Salford
Organization:
University of Salford
Study Overview
Official Title:
The Association Between Pre-operative Pain Psychology and Hypersensitivity With Poor Functional Outcome After Knee Replacement
Status:
SUSPENDED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
COVID-19
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To explore whether there are factors that help us to understand why some patient outcomes are not successful and identify prediction factors for progression Assess central pain sensitisation and psychology pre- and post-surgery with reliable tools that explore prediction tools for goodpoor progression and improve patient selection patient preparation and timing for surgery
The aim of this project is to explore the effects of pre-surgical central pain sensitisation on pain and function outcomes post-TKA Central pain sensitisation will be assessed using pressure algometry and the Pain Catastrophizing Scale will be used to explore pain psychology Functional outcomes post-TKA will be assessed using a commonly used scale for patients self-reported outcomes Oxford Knee Score visual analogue scale a star excursion balance test and four recommended patient performance-based tests
The aim of this project is to explore the effects of pre-surgical central pain sensitisation on pain and function outcomes post-TKA Central pain sensitisation will be assessed using pressure algometry and the Pain Catastrophizing Scale will be used to explore pain psychology Functional outcomes post-TKA will be assessed using a commonly used scale for patients self-reported outcomes Oxford Knee Score visual analogue scale a star excursion balance test and four recommended patient performance-based tests
Detailed Description:
Knee osteoarthritis OA is a major cause of disability around the world it is the most common chronic condition in primary care in the UK By 2030 it is predicted to be the greatest cause of disability in the general population An effective end-stage treatment for knee OA is knee-replacement surgery which was first done in the 1970s and 1980s
In England and Wales the number of knee-replacement procedures recorded by the National Joint Registry in 2013 was 91703 which represents an increase of 09 over 2012 The data analysis by the National Joint Registry and the Office of National Statistics suggests that by 2030 primary TKAs will increase by 117 from the 2012 level Subsequently TKA revision surgeries are expected to increase incrementally by 332 There is a similar estimation of demand for revision TKA surgeries in the United States by 2030 they are expected to rise by 601 from the 2005 level The United States estimation of primary TKA is for growth of 673 from the 2005 level which is similar to England and Waless upper-limit projections
Post-TKA 75-85 of patients report satisfaction with surgery outcomes while the remaining 15-25 are dissatisfied Total knee arthroplastys success has traditionally been evaluated from the surgeons perspective eg the presence of surgical complications or implant survival This is gradually changing to involve the patient in measuring health outcomes and decision-making processes Patient-reported outcome measures PROMs have evolved to explore patient perspectives by monitoring the quality of care in health organizations and conducting clinical trial outcomes
Worldwide National Joint Registry summarise the common indication for TKA revision are 298 due to aseptic loosening 148 infection and 95 due to pain Most prediction studies show that pain and psychology pre-operation may predict poor outcomes post-TKA A systematic review by concludes that pain catastrophizing predicts chronic pain post-TKA Pain catastrophizing is defined as a construct that reflects anxious preoccupation with pain an inability to inhibit pain-related fears amplification of the significance of pain vis-à-vis health implications and a sense of helplessness regarding pain
Chronic post-surgery pain is significantly associated with preoperational central sensitisation as in post-shoulder subacrominal decompression and hernia repair Regarding post-TKA a study by Lundblad et al 2008 concluded that the preoperational hand electrical pain threshold significantly predicts pain outcomes one year post-TKA The study explored the association between chronic pain post-TKA and preoperation widespread pain sensitisation using pressure algometry Both study association without control the psychological confiding factor The correlation with Western Ontario and McMaster Universities Osteoarthritis Index pain score WOMAC is questionable due to weakness of WOMAC with post TKA population such as low sensitivity of WOMACs stiffness subscale reduces the overall standardized response mean and high ceiling effect Psychological pain thinking is assessed using the most widely used measuring scale Pain Catastrophizing Scale PCS PCS assesses pain thinking in three dimensions rumination I cant stop thinking about how much it hurts magnification I worry that something serious may happen and helplessness Its awful and I feel that it overwhelms me
The current study will investigate preoperational central sensitisation using pressure algometry in addition to the Pain Catastrophizing Scale PCS to explore psychological factors There may be some correlation between preoperational central sensitisation and post-TKA outcomes such as pain and functional improvements
To the best of our knowledge no previous study has explored central sensitisation using pressure algometry and the Pain Catastrophizing Scale and possible correlation with its effects on pain and function recovery post-TKA Pain and function can be accurately assessed before and after TKA using visual analogue scale Oxford Knee Score balance and performance functional tests No previous study has correlated preoperational central sensitisation and pain psychology post-TKA on the Oxford Knee Scale as commonly used patients self-reported outcome measures
Thus the study may explore accurate and objective prediction factors of post-total-knee arthroplasty progression Potentially reliable outcome prediction could however improve patient selection for surgery as appropriate timing for surgery depends on patient symptoms and efficient patient preparation for surgery if it is to be cost-effective Accurate preoperative prediction is crucial to minimize the potential for unrealistic expectations
In England and Wales the number of knee-replacement procedures recorded by the National Joint Registry in 2013 was 91703 which represents an increase of 09 over 2012 The data analysis by the National Joint Registry and the Office of National Statistics suggests that by 2030 primary TKAs will increase by 117 from the 2012 level Subsequently TKA revision surgeries are expected to increase incrementally by 332 There is a similar estimation of demand for revision TKA surgeries in the United States by 2030 they are expected to rise by 601 from the 2005 level The United States estimation of primary TKA is for growth of 673 from the 2005 level which is similar to England and Waless upper-limit projections
Post-TKA 75-85 of patients report satisfaction with surgery outcomes while the remaining 15-25 are dissatisfied Total knee arthroplastys success has traditionally been evaluated from the surgeons perspective eg the presence of surgical complications or implant survival This is gradually changing to involve the patient in measuring health outcomes and decision-making processes Patient-reported outcome measures PROMs have evolved to explore patient perspectives by monitoring the quality of care in health organizations and conducting clinical trial outcomes
Worldwide National Joint Registry summarise the common indication for TKA revision are 298 due to aseptic loosening 148 infection and 95 due to pain Most prediction studies show that pain and psychology pre-operation may predict poor outcomes post-TKA A systematic review by concludes that pain catastrophizing predicts chronic pain post-TKA Pain catastrophizing is defined as a construct that reflects anxious preoccupation with pain an inability to inhibit pain-related fears amplification of the significance of pain vis-à-vis health implications and a sense of helplessness regarding pain
Chronic post-surgery pain is significantly associated with preoperational central sensitisation as in post-shoulder subacrominal decompression and hernia repair Regarding post-TKA a study by Lundblad et al 2008 concluded that the preoperational hand electrical pain threshold significantly predicts pain outcomes one year post-TKA The study explored the association between chronic pain post-TKA and preoperation widespread pain sensitisation using pressure algometry Both study association without control the psychological confiding factor The correlation with Western Ontario and McMaster Universities Osteoarthritis Index pain score WOMAC is questionable due to weakness of WOMAC with post TKA population such as low sensitivity of WOMACs stiffness subscale reduces the overall standardized response mean and high ceiling effect Psychological pain thinking is assessed using the most widely used measuring scale Pain Catastrophizing Scale PCS PCS assesses pain thinking in three dimensions rumination I cant stop thinking about how much it hurts magnification I worry that something serious may happen and helplessness Its awful and I feel that it overwhelms me
The current study will investigate preoperational central sensitisation using pressure algometry in addition to the Pain Catastrophizing Scale PCS to explore psychological factors There may be some correlation between preoperational central sensitisation and post-TKA outcomes such as pain and functional improvements
To the best of our knowledge no previous study has explored central sensitisation using pressure algometry and the Pain Catastrophizing Scale and possible correlation with its effects on pain and function recovery post-TKA Pain and function can be accurately assessed before and after TKA using visual analogue scale Oxford Knee Score balance and performance functional tests No previous study has correlated preoperational central sensitisation and pain psychology post-TKA on the Oxford Knee Scale as commonly used patients self-reported outcome measures
Thus the study may explore accurate and objective prediction factors of post-total-knee arthroplasty progression Potentially reliable outcome prediction could however improve patient selection for surgery as appropriate timing for surgery depends on patient symptoms and efficient patient preparation for surgery if it is to be cost-effective Accurate preoperative prediction is crucial to minimize the potential for unrealistic expectations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None