Outcome After Total Knee ArthroplastyNCT03132064
The Association Between Pre-operative Pain Psychology and Hypersensitivity With Poor Functional Outcome After Knee Replacement.
An observational study of Outcome After Total Knee Arthroplasty, run by University of Salford at 1 site in United Kingdom.
Trial 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 good/poor progression and improve… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Outcome After Total Knee Arthroplasty
- What is being tested?
- total knee arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Sep 2020to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: The present study is a prospective randomised 6 months follow-up. All patients scheduled for elective primary unilateral total knee arthroplasty for end-stage knee osteoarthritis with stable and controlled medical condition will asked for participation in preadmission orthopaedics clinic visit at Stepping Hill Hospital. The information sheet will give to all participants agreed to participate to clarify the objective of study (Appendix 1). Before commencement, patients will sign a consent form (Appendix 2) and have the right to clarify any enquiry regarding the study with the researcher. The patient's participation will not affect the quality of service, all patients will received conventional orthopaedic care and a standard amount of physiotherapy according to hospital protocols.
Who may be able to join
- All patients scheduled for elective primary unilateral total knee arthroplasty for end-stage knee osteoarthritis with stable and controlled medical condition
Who cannot join
- Potential research participants were excluded from the study if ;
- The patients schedule for bilateral knee arthroplasty or unilateral knee revision surgery.
- The patient cannot read and understand English language.
- Their function limited due to other musculoskeletal involvements other than unilateral knee osteoarthritis.
- Diagnosed with uncontrolled diabetes mellitus or blood pressure.
- Diagnosed with any neurologic disorders such as stroke, Parkinson disease or multiple sclerosis.
Show all 10Show fewer
- morbid obese patients their body mass index BMI greater than 40.
- Advance osteoporosis or other unstable chronic disease.
- Diagnosed with peripheral vascular diseases or uncontrolled cardiac diseases.
- The participant will excluded post-surgery if they develop any surgical complication such as deep vein thrombosis, uncontrolled infection, or fracture
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Stockport NHS Foundation Trust
Stockport, Manchester, SK2 7JE
About this study
Official title: The Association Between Pre-operative Pain Psychology and Hypersensitivity With Poor Functional Outcome After Knee Replacement
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 good/poor 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.
Read the 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 91,703, which represents an increase of 0.9 % 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 Wales's upper-limit projections.
Post-TKA, 75-85% of patients report satisfaction with surgery outcomes, while the remaining 15-25% are dissatisfied . Total knee arthroplasty's success has traditionally been evaluated from the surgeon's perspective, e.g. 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; 29.8% due to aseptic loosening, 14.8% infection and 9.5% 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 WOMAC's 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 can't stop thinking about how much it hurts"), magnification ("I worry that something serious may happen") and helplessness ("It's 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.
- Conditions
- Outcome After Total Knee Arthroplasty
- Being tested
- total knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total knee arthroplastyProcedure or surgery
Also called total knee replacement surgery
surgical repair for end stage of knee osteoarthritis.
| Study group | Role | What they receive |
|---|---|---|
| post total knee arthroplasty | The measurements will made for patients before and after total knee arthroplasty to explore the improvements and possible correlation with preoperative pain psychology and hypersensitivity Receives: Procedure: total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Pain Catastrophizing Scale (PCS)
Catastrophizing contributes to heightened levels of pain, emotional distress, chronic pain and disability (Forsythe, Dunbar, Hennigar, Sullivan, \& Gross, 2008).
The PCS has 13 items and can be completed and scored in less than 5 minutes. It reflects past painful experiences and indicates the degree to which patients experience each of 13 thoughts or feelings when in pain. It has 5-point scales with end points (0) not at all and (4) all the time. Between the 50th and 75th percentiles of PCS score, patients are considered at moderate risk and at more than the 75th percentile they are consider at high risk for developing chronicity. It is a reliable and valid catastrophizing measure, it shows excellent internal consistency, total score coefficient alphas = .87-.93 and significant correlation with the Inventory of Negative Thoughts in Response to Pain scale and general psychological disturbance (MASQGeneral Disturbance) scale (Osman et al., 1997; Sullivan \& et al., 1995) (Appendix 3).
Measured: before surgery and 6 months after
Changes in Central Sensitisation using pressure algometry
Pressure will be applied using a handheld pressure algometer (Algometer Type II, Somedic AB, Sweden) at a rate of 30 kPa/s perpendicular to the skin with a 1 cm² probe. The pressure pain threshold will be estimated by instructing participants to say 'stop' when the sensation of pressure becomes the first sensation of pain (Arendt-Nielsen et al., 2010; Lunn, Kristensen, Gaarn-Larsen, \& Kehlet, 2012; Skou et al., 2013). Pressure will be applied to the medial side of the operated knee and the volar surface of the same side forearm. These two body sites are chosen because they represent painful areas in knee OA patients and may provide evidence of widespread pain sensitisation (forearm) and localised pain sensitisation (knee) (Wylde, Palmer, Learmonth, \& Dieppe, 2011; Wylde et al., 2013). The site for knee pressure will be at 3 cm medial to the midpoint on the medial edge of the index patella
Measured: before surgery and 6 months after
Secondary outcomes (8)
Changes in Oxford Knee Score (OKS)
A final version of a 12-item questionnaire was developed to assess patients post-TKA after interviews with patients undergoing joint replacement and a multiple drafting process to identify their experiences and problems post-TKA since 1998 (Appendix 4).
OKS is a valid, reliable and responsive assessment tool for the period post-TKA, it has advantages over the Western Ontario and McMaster Universities Osteoarthritis Index - Knee Injury and Osteoarthritis Outcome Score, as it simple and short. As a PROM's main concern is to explore outcomes from the patient's perspective, OKS has the advantage of offering clear MIDC values for all types of study and is designed to ensure that results are recognized by patients, in addition to statistical differences, and this may improve the power calculation (Beard et al., 2015; Clement, MacDonald, Patton, \& Burnett, 2015; Clement, MacDonald, \& Simpson, 2014; Dawson, Fitzpatrick, Murray, \& Carr, 1998)
Measured: before surgery and 6 months after
Changes in pain visual analogue scale (VAS);
The pain visual analogue scale will used to assess the pain before and after the surgery. The scale consist of a 100 mm long horizontal line ranging from no pain to intolerable pain (Appendix 4). Patients will instruct to mark the line at the point matched their pain. The assessor will measure with ruler the millimetres and converted to points (0 points no pain to 100 points intolerable pain) (Bullens, van Loon, de Waal Malefijt, Laan, \& Veth, 2001).
Measured: before surgery and 6 months after
Changes in Assessment of Performance based measurements (30 s chair-stand test)
Based in published protocol, the chair with 17 inches (45cm) height with starting position will be sitting with arm cross the chest. The patients will instruct to stand then sit with good buttock placement, back support, hand on arm rest and foot placements then stand again as fast and safe as they can. The assessor will count the number of complete chair stand within the 30 second. The mean of two trail will use for analysis (Gill \& McBurney, 2008; Unver, Kalkan, Yuksel, Kahraman, \& Karatosun, 2015).
Measured: before surgery and 6 months after
Changes in stair-climb test
The assessor will measure the time required using timed stopwatch within one hundredth of second using one handrail if required to ascend and descend flight of twelve 18-cm-high steps and 28 cm depth. The patients will instruct to ascend and descend the stairs as quickly, safe and comfortable they can. The mean of two trail will use for analysis (Mizner et al., 2011).
Measured: before surgery and 6 months after
Changes in Timed up-and-go test
According to published protocol the test procedure will be as following based on used timed stopwatch within one hundredth of second, standard height chair of 45cm with arm rest will placed on an outdoor level footpath and a line 3 meters from the chair will draw. The patients will instruct to rise from chair using the arms if required, walk for 3 meter until the line mark then turn back to sit on the chair as quickly, safe and comfortable they can. The assessor commenced timing as the patient leaned forward to stand up, and stop when the patient hips made contact with the seat to sit down. Average of 3 performance will analysis (Ko, Naylor, Harris, Crosbie, \& Yeo, 2013; Mizner et al., 2011; Podsiadlo \& Richardson, 1991).
Measured: before surgery and 6 months after
Changes in Six minute walk test
Based on the test published guideline the test will measure how far the patients can walk in 6 minute in level surface, 25 meter footpath. The patient can use the assistive device if required, take rest if need with standardized encouragement after each minute. The assessor will ask the patient to stop at 6 minute. One test will be perform to avoid fatigue ("ATS Statement," 2002; Ko et al., 2013; Mizner et al., 2011).
Measured: before surgery and 6 months after
Changes in Balance Test
Balance will be assessed using the simple Star Excursion Balance Test, which is considered to be a reliable, valid dynamic test to identify dynamic balance deficits in patients with lower extremity conditions. The assessor will measure the reach distance in each direction in centimetres and then normalise the average of the three trials to leg length. Limb length will be measured while lying in a supine position from anterior superior iliac spine to the centre of the ipsilateral medial malleolus. Reach distances will be normalised to limb length by calculating the maximum reach distance (%MAXD) using the formula (excursion distance/limb length) ×100 (Coughlan, Fullam, Delahunt, Gissane, \& Caulfield, 2012; Fullam et al., 2014; Robinson \& Gribble, 2008).
Measured: before surgery and 6 months after
Changes in Physical activity
measurements will be made using an activPAL activity monitor (PAL Technologies, Glasgow, UK) as this proven accelerometer provides objective quantification of free-living physical activity without any modification (Dahlgren, Carlsson, Moorhead, Hager-Ross, \& McDonough, 2010; Schmalzried et al., 1998). It is suitable as it light in weight (20g), includes an inclinometer and is small in size (53 x 35 x 7 mm) Figure 3. The device is worn by patient's mid-thigh, secured by non-allergic waterproof adhesive tape under their clothes, for 7-10 days before surgery and 6 months after. Clear written and verbal instructions will be given to patients as they have to wear it all day and all night except, when bathing or swimming (they can take a shower with it on).
Measured: before surgery and 6 months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start12 Sep 2020 (estimated)
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Outcome After Total Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salford
- Sponsor type
- University, hospital or other
- Collaborators
- Stockport NHS Foundation Trust
- Responsible party
- Principal investigator, Bodor Bin sheeha, University of Salford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03132064
- Sponsor's protocol ID
- usalford- prospective
- Status last verified
- May 2020
- First submitted
- 11 Apr 2017
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arendt-Nielsen L, Nie H, Laursen MB, Laursen BS, Madeleine P, Simonsen OH, Graven-Nielsen T. Sensitization in patients with painful knee osteoarthritis. Pain. 2010 Jun;149(3):573-581. doi: 10.1016/j.pain.2010.04.003. Epub 2010 Apr 24.
PubMed 20418016Bade MJ, Wolfe P, Zeni JA, Stevens-Lapsley JE, Snyder-Mackler L. Predicting poor physical performance after total knee arthroplasty. J Orthop Res. 2012 Nov;30(11):1805-10. doi: 10.1002/jor.22140. Epub 2012 Apr 26.
PubMed 22539338Beard DJ, Harris K, Dawson J, Doll H, Murray DW, Carr AJ, Price AJ. Meaningful changes for the Oxford hip and knee scores after joint replacement surgery. J Clin Epidemiol. 2015 Jan;68(1):73-9. doi: 10.1016/j.jclinepi.2014.08.009. Epub 2014 Oct 31.
PubMed 25441700Burns LC, Ritvo SE, Ferguson MK, Clarke H, Seltzer Z, Katz J. Pain catastrophizing as a risk factor for chronic pain after total knee arthroplasty: a systematic review. J Pain Res. 2015 Jan 5;8:21-32. doi: 10.2147/JPR.S64730. eCollection 2015.
PubMed 25609995Clement ND, MacDonald D, Patton JT, Burnett R. Post-operative Oxford knee score can be used to indicate whether patient expectations have been achieved after primary total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2015 Jun;23(6):1578-90. doi: 10.1007/s00167-014-2865-0. Epub 2014 Feb 1.
PubMed 24488224Clement ND, MacDonald D, Simpson AH. The minimal clinically important difference in the Oxford knee score and Short Form 12 score after total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2014 Aug;22(8):1933-9. doi: 10.1007/s00167-013-2776-5. Epub 2013 Nov 20.
PubMed 24253376Coughlan GF, Fullam K, Delahunt E, Gissane C, Caulfield BM. A comparison between performance on selected directions of the star excursion balance test and the Y balance test. J Athl Train. 2012 Jul-Aug;47(4):366-71. doi: 10.4085/1062-6050-47.4.03.
PubMed 22889651Dawson J, Fitzpatrick R, Murray D, Carr A. Questionnaire on the perceptions of patients about total knee replacement. J Bone Joint Surg Br. 1998 Jan;80(1):63-9. doi: 10.1302/0301-620x.80b1.7859.
PubMed 9460955Forsythe ME, Dunbar MJ, Hennigar AW, Sullivan MJ, Gross M. Prospective relation between catastrophizing and residual pain following knee arthroplasty: two-year follow-up. Pain Res Manag. 2008 Jul-Aug;13(4):335-41. doi: 10.1155/2008/730951.
PubMed 18719716Fullam K, Caulfield B, Coughlan GF, Delahunt E. Kinematic analysis of selected reach directions of the Star Excursion Balance Test compared with the Y-Balance Test. J Sport Rehabil. 2014 Feb;23(1):27-35. doi: 10.1123/jsr.2012-0114. Epub 2013 Aug 12.
PubMed 23945793Gandek B. Measurement properties of the Western Ontario and McMaster Universities Osteoarthritis Index: a systematic review. Arthritis Care Res (Hoboken). 2015 Feb;67(2):216-29. doi: 10.1002/acr.22415.
PubMed 25048451Giesinger K, Hamilton DF, Jost B, Holzner B, Giesinger JM. Comparative responsiveness of outcome measures for total knee arthroplasty. Osteoarthritis Cartilage. 2014 Feb;22(2):184-9. doi: 10.1016/j.joca.2013.11.001. Epub 2013 Nov 18.
PubMed 24262431Graven-Nielsen T, Wodehouse T, Langford RM, Arendt-Nielsen L, Kidd BL. Normalization of widespread hyperesthesia and facilitated spatial summation of deep-tissue pain in knee osteoarthritis patients after knee replacement. Arthritis Rheum. 2012 Sep;64(9):2907-16. doi: 10.1002/art.34466.
PubMed 22421811Gribble PA, Hertel J, Plisky P. Using the Star Excursion Balance Test to assess dynamic postural-control deficits and outcomes in lower extremity injury: a literature and systematic review. J Athl Train. 2012 May-Jun;47(3):339-57. doi: 10.4085/1062-6050-47.3.08.
PubMed 22892416Hertel J, Braham RA, Hale SA, Olmsted-Kramer LC. Simplifying the star excursion balance test: analyses of subjects with and without chronic ankle instability. J Orthop Sports Phys Ther. 2006 Mar;36(3):131-7. doi: 10.2519/jospt.2006.36.3.131.
PubMed 16596889
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Pre-operative Pain Psychology and Hypersensitivity With Poor Functional Outcome After Knee Replacement
- ClinicalTrials.gov ID
- NCT03132064
- Acronym / sponsor ID
- usalford- prospective
- Conditions
- Outcome After Total Knee Arthroplasty
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: COVID-19
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of SalfordUniversity, hospital or other
- Collaborators
- Stockport NHS Foundation Trust
- Study start
- 12 Sep 2020 (estimated)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 27 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 good/poor 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.
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 91,703, which represents an increase of 0.9 % 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 Wales's upper-limit projections.
Post-TKA, 75-85% of patients report satisfaction with surgery outcomes, while the remaining 15-25% are dissatisfied . Total knee arthroplasty's success has traditionally been evaluated from the surgeon's perspective, e.g. 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; 29.8% due to aseptic loosening, 14.8% infection and 9.5% 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 WOMAC's 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 can't stop thinking about how much it hurts"), magnification ("I worry that something serious may happen") and helplessness ("It's 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| post total knee arthroplasty | – | Procedure: total knee arthroplastyThe measurements will made for patients before and after total knee arthroplasty to explore the improvements and possible correlation with preoperative pain psychology and hypersensitivity |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The present study is a prospective randomised 6 months follow-up. All patients scheduled for elective primary unilateral total knee arthroplasty for end-stage knee osteoarthritis with stable and controlled medical condition will asked for participation in preadmission orthopaedics clinic visit at Stepping Hill Hospital. The information sheet will give to all participants agreed to participate to clarify the objective of study (Appendix 1). Before commencement, patients will sign a consent form (Appendix 2) and have the right to clarify any enquiry regarding the study with the researcher. The patient's participation will not affect the quality of service, all patients will received conventional orthopaedic care and a standard amount of physiotherapy according to hospital protocols.
Key inclusion criteria (1 listed)
- All patients scheduled for elective primary unilateral total knee arthroplasty for end-stage knee osteoarthritis with stable and controlled medical condition
Key exclusion criteria (10 listed)
- Potential research participants were excluded from the study if ;
- The patients schedule for bilateral knee arthroplasty or unilateral knee revision surgery.
- The patient cannot read and understand English language.
- Their function limited due to other musculoskeletal involvements other than unilateral knee osteoarthritis.
- Diagnosed with uncontrolled diabetes mellitus or blood pressure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| total knee arthroplastyAlso: total knee replacement surgerysurgical repair for end stage of knee osteoarthritis. | Procedure or surgery | post total knee arthroplasty |
Primary outcome
Changes in Pain Catastrophizing Scale (PCS)
Time frame: before surgery and 6 months after
Catastrophizing contributes to heightened levels of pain, emotional distress, chronic pain and disability (Forsythe, Dunbar, Hennigar, Sullivan, \& Gross, 2008). The PCS has 13 items and can be completed and scored in less than 5 minutes. It reflects past painful experiences and indicates the degree to which patients experience each of 13 thoughts or feelings when in pain. It has 5-point scales with end points (0) not at all and (4) all the time. Between the 50th and 75th percentiles of PCS score, patients are considered at moderate risk and at more than the 75th percentile they are consider at high risk for developing chronicity. It is a reliable and valid catastrophizing measure, it shows excellent internal consistency, total score coefficient alphas = .87-.93 and significant correlation with the Inventory of Negative Thoughts in Response to Pain scale and general psychological disturbance (MASQGeneral Disturbance) scale (Osman et al., 1997; Sullivan \& et al., 1995) (Appendix 3).
Changes in Central Sensitisation using pressure algometry
Time frame: before surgery and 6 months after
Pressure will be applied using a handheld pressure algometer (Algometer Type II, Somedic AB, Sweden) at a rate of 30 kPa/s perpendicular to the skin with a 1 cm² probe. The pressure pain threshold will be estimated by instructing participants to say 'stop' when the sensation of pressure becomes the first sensation of pain (Arendt-Nielsen et al., 2010; Lunn, Kristensen, Gaarn-Larsen, \& Kehlet, 2012; Skou et al., 2013). Pressure will be applied to the medial side of the operated knee and the volar surface of the same side forearm. These two body sites are chosen because they represent painful areas in knee OA patients and may provide evidence of widespread pain sensitisation (forearm) and localised pain sensitisation (knee) (Wylde, Palmer, Learmonth, \& Dieppe, 2011; Wylde et al., 2013). The site for knee pressure will be at 3 cm medial to the midpoint on the medial edge of the index patella
8 secondary outcomes
Changes in Oxford Knee Score (OKS)
Time frame: before surgery and 6 months after
Changes in pain visual analogue scale (VAS);
Time frame: before surgery and 6 months after
Changes in Assessment of Performance based measurements (30 s chair-stand test)
Time frame: before surgery and 6 months after
Changes in stair-climb test
Time frame: before surgery and 6 months after
Changes in Timed up-and-go test
Time frame: before surgery and 6 months after
Changes in Six minute walk test
Time frame: before surgery and 6 months after
Changes in Balance Test
Time frame: before surgery and 6 months after
Changes in Physical activity
Time frame: before surgery and 6 months after
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Background: PubMed 20418016Arendt-Nielsen L, Nie H, Laursen MB, Laursen BS, Madeleine P, Simonsen OH, Graven-Nielsen T. Sensitization in patients with painful knee osteoarthritis. Pain. 2010 Jun;149(3):573-581. doi: 10.1016/j.pain.2010.04.003. Epub 2010 Apr 24.
- Background: PubMed 22539338Bade MJ, Wolfe P, Zeni JA, Stevens-Lapsley JE, Snyder-Mackler L. Predicting poor physical performance after total knee arthroplasty. J Orthop Res. 2012 Nov;30(11):1805-10. doi: 10.1002/jor.22140. Epub 2012 Apr 26.
- Background: PubMed 25441700Beard DJ, Harris K, Dawson J, Doll H, Murray DW, Carr AJ, Price AJ. Meaningful changes for the Oxford hip and knee scores after joint replacement surgery. J Clin Epidemiol. 2015 Jan;68(1):73-9. doi: 10.1016/j.jclinepi.2014.08.009. Epub 2014 Oct 31.
- Background: PubMed 25609995Burns LC, Ritvo SE, Ferguson MK, Clarke H, Seltzer Z, Katz J. Pain catastrophizing as a risk factor for chronic pain after total knee arthroplasty: a systematic review. J Pain Res. 2015 Jan 5;8:21-32. doi: 10.2147/JPR.S64730. eCollection 2015.
- Background: PubMed 24488224Clement ND, MacDonald D, Patton JT, Burnett R. Post-operative Oxford knee score can be used to indicate whether patient expectations have been achieved after primary total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2015 Jun;23(6):1578-90. doi: 10.1007/s00167-014-2865-0. Epub 2014 Feb 1.
- Background: PubMed 24253376Clement ND, MacDonald D, Simpson AH. The minimal clinically important difference in the Oxford knee score and Short Form 12 score after total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2014 Aug;22(8):1933-9. doi: 10.1007/s00167-013-2776-5. Epub 2013 Nov 20.
- Background: PubMed 22889651Coughlan GF, Fullam K, Delahunt E, Gissane C, Caulfield BM. A comparison between performance on selected directions of the star excursion balance test and the Y balance test. J Athl Train. 2012 Jul-Aug;47(4):366-71. doi: 10.4085/1062-6050-47.4.03.
- Background: PubMed 9460955Dawson J, Fitzpatrick R, Murray D, Carr A. Questionnaire on the perceptions of patients about total knee replacement. J Bone Joint Surg Br. 1998 Jan;80(1):63-9. doi: 10.1302/0301-620x.80b1.7859.
- Background: PubMed 18719716Forsythe ME, Dunbar MJ, Hennigar AW, Sullivan MJ, Gross M. Prospective relation between catastrophizing and residual pain following knee arthroplasty: two-year follow-up. Pain Res Manag. 2008 Jul-Aug;13(4):335-41. doi: 10.1155/2008/730951.
- Background: PubMed 23945793Fullam K, Caulfield B, Coughlan GF, Delahunt E. Kinematic analysis of selected reach directions of the Star Excursion Balance Test compared with the Y-Balance Test. J Sport Rehabil. 2014 Feb;23(1):27-35. doi: 10.1123/jsr.2012-0114. Epub 2013 Aug 12.
- Background: PubMed 25048451Gandek B. Measurement properties of the Western Ontario and McMaster Universities Osteoarthritis Index: a systematic review. Arthritis Care Res (Hoboken). 2015 Feb;67(2):216-29. doi: 10.1002/acr.22415.
- Background: PubMed 24262431Giesinger K, Hamilton DF, Jost B, Holzner B, Giesinger JM. Comparative responsiveness of outcome measures for total knee arthroplasty. Osteoarthritis Cartilage. 2014 Feb;22(2):184-9. doi: 10.1016/j.joca.2013.11.001. Epub 2013 Nov 18.
- Individual participant dataSharing planned: No
Related trials for Outcome After Total Knee Arthroplasty
RecruitingObservational study
Preoperative Multimorbidity and Functional Recovery After Total Knee Arthroplasty
Knee Osteoarthritis, Multimorbidity
Active, not recruitingObservational study
Development of a New Patient Reported Outcome Measure (PROM) to Assess Patient's Emotional Wellbeing, and Perceptions of Total Knee Replacement Surgery for the Treatment of Knee Arthritis
Complete Questionnaires Following TKR Surgery
RecruitingObservational study
Prediction of Postoperative Outcomes After TKA Using Instrumented Insoles and DNN
Knee Osteoarthritis, Total Knee Arthroplasty
Recruiting
Evaluation of Ioband Coverage Waterproof Dressing Versus Isolated Waterproof Dressing After Primary Total Knee Arthroplasty
Postoperative Wound Care After TKA
Active, not recruiting
Efficacy of Kinesiotaping During Rehabilitation Following Total Knee Replacement Surgery
Total Knee Replacement, Postoperative Recovery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Outcome After Total Knee Arthroplasty, run by University of Salford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Pain Catastrophizing Scale (PCS) (time frame: before surgery and 6 months after). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03132064, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2020.