The Association Between Pre-operative Pain Psychology and Hypersensitivity With Poor Functional Outcome After Knee Replacement.

NCT03132064 | Suspended DMC

• 1 other identifier: usalford- prospective
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Outcome After Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (2)

• 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).

  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

  before surgery and 6 months after

Secondary Outcomes (8)

• Changes in Oxford Knee Score (OKS)

  before surgery and 6 months after

• Changes in pain visual analogue scale (VAS);

  before surgery and 6 months after

• Changes in Assessment of Performance based measurements (30 s chair-stand test)

  before surgery and 6 months after

• Changes in stair-climb test

  before surgery and 6 months after

• Changes in Timed up-and-go test

  before surgery and 6 months after

Study Arms (1)

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

Procedure: total knee arthroplasty

Interventions

total knee arthroplasty PROCEDURE

surgical repair for end stage of knee osteoarthritis.

Also known as: total knee replacement surgery

post total knee arthroplasty

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• All patients scheduled for elective primary unilateral total knee arthroplasty for end-stage knee osteoarthritis with stable and controlled medical condition

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• University of Salford: lead
• Stockport NHS Foundation Trust: collaborator

Study Sites (1)

Stockport NHS Foundation Trust

Stockport, Manchester, SK2 7JE, United Kingdom

Location

Related Publications (26)

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  PMID: 20418016 BACKGROUND

• Bade 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.

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• Beard 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.

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• Burns 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.

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• Clement 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.

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• Clement 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.

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• Coughlan 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.

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• Forsythe 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.

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• Fullam 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.

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• Gandek 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.

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• Giesinger 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.

  PMID: 24262431 BACKGROUND

• Graven-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.

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• Gribble 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.

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• Hertel 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.

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• Khan M, Osman K, Green G, Haddad FS. The epidemiology of failure in total knee arthroplasty: avoiding your next revision. Bone Joint J. 2016 Jan;98-B(1 Suppl A):105-12. doi: 10.1302/0301-620X.98B1.36293.

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• Lundblad H, Kreicbergs A, Jansson KA. Prediction of persistent pain after total knee replacement for osteoarthritis. J Bone Joint Surg Br. 2008 Feb;90(2):166-71. doi: 10.1302/0301-620X.90B2.19640.

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• Lungu E, Desmeules F, Dionne CE, Belzile EL, Vendittoli PA. Prediction of poor outcomes six months following total knee arthroplasty in patients awaiting surgery. BMC Musculoskelet Disord. 2014 Sep 8;15:299. doi: 10.1186/1471-2474-15-299.

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• Lunn TH, Kristensen BB, Gaarn-Larsen L, Kehlet H. Possible effects of mobilisation on acute post-operative pain and nociceptive function after total knee arthroplasty. Acta Anaesthesiol Scand. 2012 Nov;56(10):1234-40. doi: 10.1111/j.1399-6576.2012.02744.x. Epub 2012 Aug 10.

  PMID: 22881199 BACKGROUND

• Osman A, Barrios FX, Kopper BA, Hauptmann W, Jones J, O'Neill E. Factor structure, reliability, and validity of the Pain Catastrophizing Scale. J Behav Med. 1997 Dec;20(6):589-605. doi: 10.1023/a:1025570508954.

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• Robinson RH, Gribble PA. Support for a reduction in the number of trials needed for the star excursion balance test. Arch Phys Med Rehabil. 2008 Feb;89(2):364-70. doi: 10.1016/j.apmr.2007.08.139.

  PMID: 18226664 BACKGROUND

• Skou ST, Graven-Nielsen T, Rasmussen S, Simonsen OH, Laursen MB, Arendt-Nielsen L. Widespread sensitization in patients with chronic pain after revision total knee arthroplasty. Pain. 2013 Sep;154(9):1588-1594. doi: 10.1016/j.pain.2013.04.033. Epub 2013 Apr 20.

  PMID: 23707268 BACKGROUND

• Sullivan, M. J. L., & et al. (1995). The Pain Catastrophizing Scale: Development and Validation. Psychological Assessment, 7(4), 524-532.

  BACKGROUND

• Terwee CB, Bot SD, de Boer MR, van der Windt DA, Knol DL, Dekker J, Bouter LM, de Vet HC. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol. 2007 Jan;60(1):34-42. doi: 10.1016/j.jclinepi.2006.03.012. Epub 2006 Aug 24.

  PMID: 17161752 BACKGROUND

• Wylde V, Palmer S, Learmonth ID, Dieppe P. Test-retest reliability of Quantitative Sensory Testing in knee osteoarthritis and healthy participants. Osteoarthritis Cartilage. 2011 Jun;19(6):655-8. doi: 10.1016/j.joca.2011.02.009. Epub 2011 Feb 15.

  PMID: 21329759 BACKGROUND

• Wylde V, Palmer S, Learmonth ID, Dieppe P. The association between pre-operative pain sensitisation and chronic pain after knee replacement: an exploratory study. Osteoarthritis Cartilage. 2013 Sep;21(9):1253-6. doi: 10.1016/j.joca.2013.05.008.

  PMID: 23973138 BACKGROUND

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator -PhD student at University of Salford

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 27, 2017
• Study Start: September 12, 2020
• Primary Completion: February 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 27, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)