Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

Clinical- and cost-effectiveness of the STAR care pathway compared to usual care for patients with chronic pain after total knee replacement: study protocol for a UK randomised controlled trial

Authors: Vikki Wylde, Wendy Bertram, Andrew D. Beswick, Ashley W. Blom, Julie Bruce, Amanda Burston, Jane Dennis, Kirsty Garfield, Nicholas Howells, Athene Lane, Candy McCabe, Andrew J. Moore, Sian Noble, Tim J. Peters, Andrew Price, Emily Sanderson, Andrew D. Toms, David A. Walsh, Simon White, Rachael Gooberman-Hill

Published in: Trials | Issue 1/2018

Login to get access

Abstract

Background

Approximately 20% of patients experience chronic pain after total knee replacement. There is little evidence for effective interventions for the management of this pain, and current healthcare provision is patchy and inconsistent. Given the complexity of this condition, multimodal and individualised interventions matched to pain characteristics are needed. We have undertaken a comprehensive programme of work to develop a care pathway for patients with chronic pain after total knee replacement. This protocol describes the design of a randomised controlled trial to evaluate the clinical- and cost-effectiveness of a complex intervention care pathway compared with usual care.

Methods

This is a pragmatic two-armed, open, multi-centred randomised controlled trial conducted within secondary care in the UK. Patients will be screened at 2 months after total knee replacement and 381 patients with chronic pain at 3 months postoperatively will be recruited. Recruitment processes will be optimised through qualitative research during a 6-month internal pilot phase. Patients are randomised using a 2:1 intervention:control allocation ratio. All participants receive usual care as provided by their hospital. The intervention comprises an assessment clinic appointment at 3 months postoperatively with an Extended Scope Practitioner and up to six telephone follow-up calls over 12 months. In the assessment clinic, a standardised protocol is followed to identify potential underlying causes for the chronic pain and enable appropriate onward referrals to existing services for targeted and individualised treatment. Outcomes are assessed by questionnaires at 6 and 12 months after randomisation. The co-primary outcomes are pain severity and pain interference assessed using the Brief Pain Inventory at 12 months after randomisation. Secondary outcomes relate to resource use, function, neuropathic pain, mental well-being, use of pain medications, satisfaction with pain relief, pain frequency, capability, health-related quality of life and bodily pain. After trial completion, up to 30 patients in the intervention group will be interviewed about their experiences of the care pathway.

Discussion

If shown to be clinically and cost-effective, this care pathway intervention could improve the management of chronic pain after total knee replacement.

Trial registration

ISRCTN registry (ISRCTN92545361), prospectively registered on 30 August 2016.
Appendix
Available only for authorised users
Literature
1.
National Joint Registry for England, Wales, Northern Ireland and the Isle of Man. 14th Annual Report 2017. Hemel Hempstead: NJR Centre; 2017.
2.
3.
Beswick AD, Wylde V, Gooberman-Hill R, Blom A, Dieppe P. What proportion of patients report long-term pain after total hip or knee replacement for osteoarthritis? A systematic review of prospective studies in unselected patients. BMJ Open. 2012;2(1):e000435.CrossRefPubMedPubMedCentral
4.
Werner MU, Kongsgaard UE. Defining persistent post-surgical pain: is an update required? Br J Anaesth. 2014;113(1):1–4.CrossRefPubMed
5.
Scott CE, Howie CR, MacDonald D, Biant LC. Predicting dissatisfaction following total knee replacement: a prospective study of 1217 patients. J Bone Joint Surg Br. 2010;92(9):1253–8.CrossRefPubMed
6.
Nilsdotter AK, Toksvig-Larsen S, Roos EM. Knee arthroplasty: are patients' expectations fulfilled? A prospective study of pain and function in 102 patients with 5-year follow-up. Acta Orthop. 2009;80(1):55–61.CrossRefPubMedPubMedCentral
7.
Jeffery AE, Wylde V, Blom AW, Horwood JP. “It's there and I'm stuck with it”: Patients' experiences of chronic pain following total knee replacement surgery. Arthritis Care Res. 2011;63(2):286–92.CrossRef
8.
Woolhead GM, Donovan JL, Dieppe PA. Outcomes of total knee replacement: a qualitative study. Rheumatology. 2005;44(8):1032–7.CrossRefPubMed
9.
Smith BH, Elliott AM, Chambers WA, Smith WC, Hannaford PC, Penny K. The impact of chronic pain in the community. Fam Pract. 2001;18(3):292–9.CrossRefPubMed
10.
Leadley RM, Armstrong N, Reid KJ, Allen A, Misso KV, Kleijnen J. Healthy aging in relation to chronic pain and quality of life in Europe. Pain Pract. 2014;14(6):547–58.CrossRefPubMed
11.
Magni G, Caldieron C, Rigatti-Luchini S, Merskey H. Chronic musculoskeletal pain and depressive symptoms in the general population. An analysis of the 1st National Health and Nutrition Examination Survey data. Pain. 1990;43(3):299–307.CrossRefPubMed
12.
Brox JI, Storheim K, Holm I, Friis A, Reikeras O. Disability, pain, psychological factors and physical performance in healthy controls, patients with sub-acute and chronic low back pain: a case-control study. J Rehabil Med. 2005;37(2):95–9.CrossRefPubMed
13.
Silvemark AJ, Källmén H, Portala K, Molander C. Life satisfaction in patients with long-term non-malignant pain–relation to demographic factors and pain intensity. Disabil Rehabil. 2008;30(25):1929–37.CrossRefPubMed
14.
Boonstra A, Reneman M, Stewart R, Post M, Schiphorst PH. Life satisfaction in patients with chronic musculoskeletal pain and its predictors. Qual Life Res. 2013;22(1):93–101.CrossRefPubMed
15.
Hawton A, Green C, Dickens AP, Richards SH, Taylor RS, Edwards R, Greaves CJ, Campbell JL. The impact of social isolation on the health status and health-related quality of life of older people. Qual Life Res. 2011;20(1):57–67.CrossRefPubMed
16.
Wylde V, Mackichan SD, Gooberman-Hill R. Service provision for patients with chronic post-surgical pain after total knee replacement: An evaluation of current practice. J Pain Manag. 2014;7(2):147–54.
17.
Beswick AD, Wylde V, Gooberman-Hill R. Interventions for the prediction and management of chronic postsurgical pain after total knee replacement: systematic review of randomised controlled trials. BMJ Open. 2015;5(5):e007387.CrossRefPubMedPubMedCentral
18.
Wylde V, Dennis J, Beswick A, Bruce J, Eccleston C, Howells N, Peters T, Gooberman-Hill R. Systematic review of management of chronic pain after surgery. Br J Surg. 2017;104(10):1293–306.CrossRefPubMedPubMedCentral
19.
Turk DC, Wilson HD, Cahana A. Treatment of chronic non-cancer pain. Lancet. 2011;377(9784):2226–35.CrossRefPubMed
20.
Wylde V, Dieppe P, Hewlett S, Learmonth ID. Total knee replacement: Is it really an effective procedure for all? Knee. 2007;14(6):417–23.CrossRefPubMed
21.
Lundblad H, Kreicbergs A, Jansson KA. Prediction of persistent pain after total knee replacement for osteoarthritis. J Bone Joint Surg Br. 2008;90-B(2):166–71.CrossRef
22.
Wylde V, Palmer S, Learmonth ID, Dieppe P. The association between pre-operative pain sensitisation and chronic pain after knee replacement: an exploratory study. Osteoarthr Cartil. 2013;21(9):1253–6.CrossRefPubMed
23.
24.
Stanos SP, Harden RN, Wagner-Raphael L, Saltz SL. A prospective clinical model for investigating the development of CRPS. In: Harden RN, Baron R, Jänig W, editors. Complex Regional Pain Syndrome: Progress in Pain Research and Management. Seattle: IASP Press; 2001. p. 151–64.
25.
Haroutiunian S, Nikolajsen L, Finnerup NB, Jensen TS. The neuropathic component in persistent postsurgical pain: a systematic literature review. Pain. 2013;154(1):95–102.CrossRefPubMed
26.
Mandalia V, Eyres K, Schranz P, Toms AD. Evaluation of patients with a painful total knee replacement. J Bone Joint Surg Br. 2008;90(3):265–71.CrossRefPubMed
27.
Toms AD, Mandalia V, Haigh R, Hopwood B. The management of patients with painful total knee replacement. J Bone Joint Surg Br. 2009;91(2):143–50.CrossRefPubMed
28.
Hofmann S, Seitlinger G, Djahani O, Pietsch M. The painful knee after TKA: a diagnostic algorithm for failure analysis. Knee Surg Sports Traumatol Arthrosc. 2011;19(9):1442–52.CrossRefPubMed
29.
Vissers MM, Bussmann JB, Verhaar JA, Busschbach JJ, Bierma-Zeinstra SM, Reijman M. Psychological factors affecting the outcome of total hip and knee arthroplasty: a systematic review. Semin Arthritis Rheum. 2012;41(4):576–88.CrossRefPubMed
30.
Wylde V, Howells N, Bertram W, Moore A, Bruce J, McCabe C, Blom A, Dennis J, Burston A, Gooberman-Hill R. Development of a complex intervention for people with chronic pain after knee replacement: the STAR care pathway. Trials. 2018;19:61.CrossRefPubMedPubMedCentral
31.
MacKichan F, Wylde V, Gooberman-Hill R. Pathways through care for long-term pain after knee replacement: a qualitative study with healthcare professionals. Musculoskeletal Care. 2015;13(3):127–38.CrossRef
32.
Gooberman-Hill R, Burston A, Clark E, Johnson E, Nolan S, Wells V, Betts L, Pep R. Involving patients in research: considering good practice. Musculoskeletal Care. 2013;11(4):187–90.CrossRefPubMedPubMedCentral
33.
Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–7.CrossRefPubMedPubMedCentral
34.
Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.CrossRefPubMedPubMedCentral
35.
Dawson J, Fitzpatrick R, Murray D, Carr A. Questionnaire on the perceptions of patients about total knee replacement. J Bone Joint Surg Br. 1998;80(1):63–9.CrossRefPubMed
36.
Pinedo-Villanueva R, Khalid S, Wylde V, Gooberman-Hill R, Judge A. A cut-off point in the Oxford knee score to identify patients with chronic pain after knee replacement. World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases. Florence: Italy; 2017.
37.
Donovan JL, Lane JA, Peters TJ, Brindle L, Salter E, Gillatt D, Powell P, Bollina P, Neal DE, Hamdy FC. Development of a complex intervention improved randomization and informed consent in a randomized controlled trial. J Clin Epidemiol. 2009;62(1):29–36.CrossRefPubMed
38.
Cleeland CS. The Brief Pain Inventory: User Guide. Houston: University of Texas; 2009.
39.
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67(6):361–70.CrossRefPubMed
40.
Freynhagen R, Baron R, Gockel U, Tolle TR. painDETECT: a new screening questionnaire to identify neuropathic components in patients with back pain. Curr Med Res Opin. 2006;22(10):1911–20.CrossRefPubMed
41.
Bouhassira D, Attal N, Alchaar H, Boureau F, Brochet B, Bruxelle J, Cunin G, Fermanian J, Ginies P, Grun-Overdyking A, Jafari-Schluep H, Lanteri-Minet M, Laurent B, Mick G, Serrie A, Valade D, Vicaut E. Comparison of pain syndromes associated with nervous or somatic lesions and development of a new neuropathic pain diagnostic questionnaire (DN4). Pain. 2005;114(1–2):29–36.CrossRefPubMed
42.
Harden RN, Bruehl S, Perez RS, Birklein F, Marinus J, Maihofner C, Lubenow T, Buvanendran A, Mackey S, Graciosa J, Mogilevski M, Ramsden C, Chont M, Vatine JJ. Validation of proposed diagnostic criteria (the "Budapest Criteria") for Complex Regional Pain Syndrome. Pain. 2010;150(2):268–74.CrossRefPubMedPubMedCentral
43.
Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, Altman DG, Barbour V, Macdonald H, Johnston M, Lamb SE, Dixon-Woods M, McCulloch P, Wyatt JC, Chan AW, Michie S. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348:g1687.CrossRefPubMed
44.
Breitenstein SM, Gross D, Garvey CA, Hill C, Fogg L, Resnick B. Implementation fidelity in community-based interventions. Res Nurs Health. 2010;33(2):164–73.PubMedPubMedCentral
45.
Wylde V, MacKichan F, Bruce J, Gooberman-Hill R. Assessment of chronic post-surgical pain after knee replacement: development of a core outcome set. Eur J Pain. 2015;19(5):611–20.CrossRefPubMed
46.
Sullivan MJL, Bishop SR, Pivik J. The Pain Catastrophizing Scale: development and validation. Psychol Assess. 1995;7(4):524–32.CrossRef
47.
De Vlieger P, Bussche EV, Eccleston C, Crombez G. Finding a solution to the problem of pain: conceptual formulation and the development of the Pain Solutions Questionnaire (PaSol). Pain. 2006;123(3):285–93.CrossRefPubMed
48.
Mahomed N, Gandh IR, Daltroy L, Katz J. The self-administered patient satisfaction scale for primary hip and knee arthroplasty. Arthritis. 2011;2011:591253.CrossRefPubMedPubMedCentral
49.
Al-Janabi H, Flynn T, Coast J. Development of a self-report measure of capability wellbeing for adults: the ICECAP-A. Qual Life Res. 2012;21(1):167–76.CrossRefPubMed
50.
Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011;20(10):1727–36.CrossRefPubMedPubMedCentral
51.
Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996;34(3):220–33.CrossRefPubMed
52.
Hunt IM, Silman AJ, Benjamin S, McBeth J, Macfarlane GJ. The prevalence and associated features of chronic widespread pain in the community using the 'Manchester' definition of chronic widespread pain. Rheumatology. 1999;38(3):275–9.CrossRefPubMed
53.
Marques E, Johnson EC, Gooberman-Hill R, Blom AW, Noble S. Using resource use logs to reduce the amount of missing data in economic evaluations alongside trials. Value Health. 2013;16(1):195–201.CrossRefPubMed
54.
Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3(2):77–101.CrossRef
55.
Guest G, Bunce A, Johnson L. How many interviews are enough? An experiment with data saturation and variability. Field Methods. 2006;18(1):59–82.CrossRef
56.
Glaser B, Strauss A. The Discovery of Grounded Theory. Chicago: Aldine; 1967.
57.
Bruce J, Thornton AJ, Powell R, Johnston M, Wells M, Heys SD, Thompson AM, Cairns Smith W, Chambers WA, Scott NW. Psychological, surgical, and sociodemographic predictors of pain outcomes after breast cancer surgery: A population-based cohort study. Pain. 2014;155(2):232–43.CrossRefPubMed
58.
Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, Haythornthwaite JA, Jensen MP, Kerns RD, Ader DN, Brandenburg N, Burke LB, Cella D, Chandler J, Cowan P, Dimitrova R, Dionne R, Hertz S, Jadad AR, Katz NP, Kehlet H, Kramer LD, Manning DC, McCormick C, McDermott MP, McQuay HJ, Patel S, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Revicki DA, Rothman M, Schmader KE, Stacey BR, Stauffer JW, von Stein T, White RE, Witter J, Zavisic S. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008;9(2):105–21.CrossRefPubMed
59.
Kroenke K, Bair MJ, Damush TM, Wu J, Hoke S, Sutherland J, Tu W. Optimized antidepressant therapy and pain self-management in primary care patients with depression and musculoskeletal pain: a randomized controlled trial. JAMA. 2009;301(20):2099–110.CrossRefPubMedPubMedCentral
60.
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–81.CrossRefPubMed
61.
62.
Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:a1655.CrossRefPubMedPubMedCentral
63.
Kim J, Lonner JH, Nelson CL, Lotke PA. Response bias: effect on outcomes evaluation by mail surveys after total knee arthroplasty. J Bone Joint Surg Am. 2004;86-A(1):15–21.CrossRefPubMed
64.
Edwards PJ, Roberts I, Clarke MJ, Diguiseppi C, Wentz R, Kwan I, Cooper R, Felix LM, Pratap S. Methods to increase response to postal and electronic questionnaires. Cochrane Database Syst Rev. 2009;3:MR000008.
65.
Dibao-Dina C, Caille A, Sautenet B, Chazelle E, Giraudeau B. Rationale for unequal randomization in clinical trials is rarely reported: a systematic review. J Clin Epidemiol. 2014;67(10):1070–5.CrossRefPubMed
66.
Peckham E, Brabyn S, Cook L, Devlin T, Dumville J, Torgerson DJ. The use of unequal randomisation in clinical trials--An update. Contemp Clin Trials. 2015;45(Pt A):113–22.CrossRefPubMed
67.
Metadata
Title
Clinical- and cost-effectiveness of the STAR care pathway compared to usual care for patients with chronic pain after total knee replacement: study protocol for a UK randomised controlled trial
Authors
Vikki Wylde
Wendy Bertram
Andrew D. Beswick
Ashley W. Blom
Julie Bruce
Amanda Burston
Jane Dennis
Kirsty Garfield
Nicholas Howells
Athene Lane
Candy McCabe
Andrew J. Moore
Sian Noble
Tim J. Peters
Andrew Price
Emily Sanderson
Andrew D. Toms
David A. Walsh
Simon White
Rachael Gooberman-Hill
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2516-8

Other articles of this Issue 1/2018

Trials 1/2018 Go to the issue

Study protocol

A web-based education program to encourage organ donation registration among lower-educated adolescents in the Netherlands: study protocol for a cluster randomized controlled trial

Study protocol

Therapeutic and pharmaco-biological, dose-ranging multicentre trial to determine the optimal dose of TRAnexamic acid to reduce blood loss in haemorrhagic CESarean delivery (TRACES): study protocol for a randomised, double-blind, placebo-controlled trial

Study protocol

Dexamethasone for adult patients with a symptomatic chronic subdural haematoma (Dex-CSDH) trial: study protocol for a randomised controlled trial

Review

An audit to evaluate an institute’s lead researchers’ knowledge of trial registries and to investigate adherence to data transparency issues in an Italian research institute registry

Study protocol

Efficacy and safety of polydioxanone thread embedded at specific acupoints for non-specific chronic neck pain: a study protocol for a randomized, subject-assessor-blinded, sham-controlled pilot trial

Study protocol

Upscaling Participatory Action and Videos for Agriculture and Nutrition (UPAVAN) trial comparing three variants of a nutrition-sensitive agricultural extension intervention to improve maternal and child nutritional outcomes in rural Odisha, India: study protocol for a cluster randomised controlled trial