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BMC Musculoskeletal Disorders
Published in: BMC Musculoskeletal Disorders 1/2021

Open Access 01-12-2021 | Osteoarthrosis | Research article

Exercise-therapy and education for individuals one year after anterior cruciate ligament reconstruction: a pilot randomised controlled trial

Authors: Brooke E. Patterson, Christian J. Barton, Adam G. Culvenor, Randall L. Cooper, Kay M. Crossley

Published in: BMC Musculoskeletal Disorders | Issue 1/2021

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Abstract

Background

Guided rehabilitation beyond 6-months is rare following anterior cruciate ligament reconstruction (ACLR), despite high prevalence of unacceptable symptoms and quality of life (QoL). Our primary aim was to determine the feasibility of a randomised controlled trial (RCT) evaluating a physiotherapist-guided intervention for individuals 1-year post-ACLR with persistent symptoms. Our secondary aim was to determine if a worthwhile treatment effect could be observed for the lower-limb focussed intervention (compared to the trunk-focussed intervention), for improvement in knee-related QoL, symptoms, and function.

Design

Participant- and assessor-blinded, pilot feasibility RCT.

Methods

Participant eligibility criteria: i) 12–15 months post-ACLR; ii) < 87.5/100 on the Knee injury and Osteoarthritis Outcome Score (KOOS) QoL subscale; and either a one-leg rise test < 22 repetitions, single-hop < 90% limb symmetry; or Anterior Knee Pain Scale < 87/100. Participants were randomised to lower-limb or trunk-focussed focussed exercise and education. Both interventions involved 8 face-to-face physiotherapy sessions over 16-weeks. Feasibility was assessed by eligibility rate (> 1 in 3 screened), recruitment rate (> 4 participants/month), retention (< 20% drop-out), physiotherapy attendance and unsupervised exercise adherence (> 80%). Between-group differences for knee-related QoL (KOOS-QoL, ACL-QoL), symptoms (KOOS-Pain, KOOS-Symptoms), and function (KOOS-Sport, functional performance tests) were used to verify that the worthwhile effect (greater than the minimal detectable change for each measure) was contained within the 95% confidence interval.

Results

47% of those screened were eligible, and 27 participants (3 participants/month; 48% men, 34±12 years) were randomised. Two did not commence treatment, and two were lost to follow-up (16% drop-out). Physiotherapy attendance was > 80% for both groups but reported adherence to unsupervised exercise was low (< 55%). Both interventions had potentially worthwhile effects for KOOS-QoL and ACL-QoL, while the lower-limb focussed intervention had potentially greater effects for KOOS-Sport, KOOS-Pain, and functional performance.

Conclusions

A larger-scale RCT is warranted. All feasibility criteria were met, or reasonable recommendations could be made to achieve the criteria in future trials. Strategies to increase recruitment rate and exercise adherence are required. The potential worthwhile effects for knee-related QoL, symptoms, and function indicates a fully-powered RCT may detect a clinically meaningful effect.

Trial registration

Prospectively registered (ACTRN12616000564​459).
Appendix
Available only for authorised users
Literature
1.
American College of Sports Medicine. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2009;41(3):687–708.CrossRef
2.
Arundale AJH, Capin JJ, Zarzycki R, Smith A, Snyder-Mackler L. Functional and patient-reported outcomes improve over the course of rehabilitation: a secondary analysis of the ACL-SPORTS trial. Sports Health. 2018;10(5):441–52 1941738118779023.PubMedPubMedCentralCrossRef
3.
Avery KNL, Williamson PR, Gamble C, O'Connell Francischetto E, Metcalfe C, et al. Informing efficient randomised controlled trials: exploration of challenges in developing progression criteria for internal pilot studies. BMJ Open. 2017;7(2):e013537.PubMedPubMedCentralCrossRef
4.
Baltaci G, Yilmaz G, Atay AO. The outcomes of anterior cruciate ligament reconstructed and rehabilitated knees versus healthy knees: a functional comparison. Acta Orthop Traumatol Turc. 2012;46(3):186–95.PubMedCrossRef
5.
Bell ML, Whitehead AL, Julious SA. Guidance for using pilot studies to inform the design of intervention trials with continuous outcomes. Clin Epidemiol. 2018;10:153–7.PubMedPubMedCentralCrossRef
6.
Bennell KL, van Ginckel A, Kean CO, Nelligan RK, French SD, et al. Patient knowledge and beliefs about knee osteoarthritis after anterior cruciate ligament injury and reconstruction. Arthritis Care Res (Hoboken). 2016;68(8):1180–5.CrossRef
7.
Bremander AB, Dahl LL, Roos EM. Validity and reliability of functional performance tests in meniscectomized patients with or without knee osteoarthritis. Scand J Med Sci Sports. 2007;17(2):120–7.PubMed
8.
Brewer BW, Van Raalte JL, Cornelius AE, Petitpas AJ, Sklar JH, et al. Psychological factors, rehabilitation adherence, and rehabilitation outcome after anterior cruciate ligament reconstruction. Rehabil Psychol. 2000;45(1):20–37.CrossRef
9.
Burgi CR, Peters S, Ardern CL, Magill JR, Gomez CD, et al. Which criteria are used to clear patients to return to sport after primary ACL reconstruction? A scoping review. Br J Sports Med. 2019;53(18):1154–61.PubMedCrossRef
10.
Collins NJ, Prinsen CA, Christensen R, Bartels EM, Terwee CB, et al. Knee injury and osteoarthritis outcome score (KOOS): systematic review and meta-analysis of measurement properties. Osteoarthr Cartil. 2016;24(8):1317–29.CrossRef
11.
Coronado RA, Bird ML, Van Hoy EE, Huston LJ, Spindler KP, et al. Do psychosocial interventions improve rehabilitation outcomes after anterior cruciate ligament reconstruction? A systematic review. Clin Rehabil. 2018;32(3):287–98.PubMedCrossRef
12.
Culvenor A, Barton C. It is time to stop wasting time and money debating graft types and surgical approaches for ACL injuries: The secret probably lies in optimising rehabilitation. British J Sports Med. 2017; Available from: https://​blogs.​bmj.​com/​bjsm/​2017/​09/​20/​. Accessed 7 July 2020.
13.
Culvenor AG, Alexander BC, Clark RA, Collins NJ, Ageberg E, et al. Dynamic single-leg postural control is impaired bilaterally following anterior cruciate ligament reconstruction: implications for Reinjury risk. J Orthop Sports Phys Ther. 2016;46(5):357–64.PubMedCrossRef
14.
Culvenor AG, Boeth H, Diederichs G, Wirth W, Duda G, et al. Longitudinal bone, muscle and adipose tissue changes in physically active subjects - sex differences during adolescence and maturity. J Musculoskelet Neuronal Interact. 2016;16(3):237–46.PubMedPubMedCentral
15.
Culvenor AG, Collins NJ, Guermazi A, Cook JL, Vicenzino B, et al. Early Patellofemoral osteoarthritis features one year after anterior cruciate ligament reconstruction: symptoms and quality of life at three years. Arthritis Care Res (Hoboken). 2016;68(6):784–92.PubMedCrossRef
16.
Culvenor AG, Collins NJ, Vicenzino B, Cook JL, Whitehead TS, et al. Predictors and effects of patellofemoral pain following hamstring-tendon ACL reconstruction. J Sci Med Sport. 2016;19(7):518–23.PubMedCrossRef
17.
Culvenor AG, Eckstein F, Wirth W, Lohmander LS, Frobell R. Loss of patellofemoral cartilage thickness over 5 years following ACL injury depends on the initial treatment strategy: results from the KANON trial. Br J Sports Med. 2019;53(18):1168–73.PubMedCrossRef
18.
Culvenor AG, Lai CC, Gabbe BJ, Makdissi M, Collins NJ, et al. Patellofemoral OA is prevalent and associated with worse symptoms and function after hamstring tendon autograft ACL reconstruction. Br J Sports Med. 2014;48(6):435–9.PubMedCrossRef
19.
Culvenor AG, Oiestad BE, Hart HF, Stefanik JJ, Guermazi A, et al. Prevalence of knee osteoarthritis features on magnetic resonance imaging in asymptomatic uninjured adults: a systematic review and meta-analysis. Br J Sports Med. 2019;53(20):1268–78.PubMedCrossRef
20.
Culvenor AG, Ruhdorfer A, Juhl C, Eckstein F, Øiestad BE. Knee extensor strength and risk of structural, symptomatic, and functional decline in knee osteoarthritis: a systematic review and meta-analysis. Arthritis Care Res. 2017;69(5):649–58.CrossRef
21.
Culvenor AG, Segal NA, Guermazi A, Roemer F, Felson DT, et al. Sex-specific influence of quadriceps weakness on worsening Patellofemoral and Tibiofemoral cartilage damage: a prospective cohort study. Arthritis Care Res (Hoboken). 2019;71(10):1360–5.PubMedPubMedCentralCrossRef
22.
De Oliveira SD, Pazzinatto MF, Rathleff MS, Holden S, Bell E, et al. Patient education for Patellofemoral pain: a systematic review. J Orthop Sports Phys Ther. 2020;50(7):388–96.CrossRef
23.
Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, et al. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016;355:i5239.PubMedPubMedCentralCrossRef
24.
Englund M, Roos EM, Lohmander LS. Impact of type of meniscal tear on radiographic and symptomatic knee osteoarthritis: a sixteen-year followup of meniscectomy with matched controls. Arthritis Rheum. 2003;48(8):2178–87.PubMedCrossRef
25.
Ericsson YB, Roos EM, Frobell RB. Lower extremity performance following ACL rehabilitation in the KANON-trial: impact of reconstruction and predictive value at 2 and 5 years. Br J Sports Med. 2013;47(15):980–5.PubMedCrossRef
26.
Filbay SR, Ackerman IN, Dhupelia S, Arden NK, Crossley KM. Quality of life in symptomatic individuals after anterior cruciate ligament reconstruction, with and without radiographic knee osteoarthritis. J Orthop Sports Phys Ther. 2018;48(5):398–408.PubMedCrossRef
27.
Filbay SR, Culvenor AG, Ackerman IN, Russell TG, Crossley KM. Quality of life in anterior cruciate ligament-deficient individuals: a systematic review and meta-analysis. Br J Sports Med. 2015;49(16):1033–41.PubMedCrossRef
28.
Furlan AD, Pennick V, Bombardier C, van Tulder M, Editorial Board CBRG. 2009 updated method guidelines for systematic reviews in the Cochrane Back review group. Spine (Phila Pa 1976). 2009;34(18):1929–41.CrossRef
29.
Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, et al. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and Neuromotor fitness in apparently healthy adults. Med Sci Sports Exerc. 2011;43(7):1334–59.PubMedCrossRef
30.
31.
32.
Grindem H, Eitzen I, Snyder-Mackler L, Risberg MA. Online registration of monthly sports participation after anterior cruciate ligament injury: a reliability and validity study. Br J Sports Med. 2014;48(9):748–53.PubMedCrossRef
33.
Grindem H, Snyder-Mackler L, Moksnes H, Engebretsen L, Risberg MA. Simple decision rules can reduce reinjury risk by 84% after ACL reconstruction: the Delaware-Oslo ACL cohort study. Br J Sports Med. 2016;50(13):804–8.PubMedCrossRef
34.
Gustavsson A, Neeter C, Thomee P, Silbernagel KG, Augustsson J, et al. A test battery for evaluating hop performance in patients with an ACL injury and patients who have undergone ACL reconstruction. Knee Surg Sports Traumatol Arthrosc. 2006;14(8):778–88.PubMedCrossRef
35.
Hart HF, Culvenor AG, Guermazi A, Crossley KM. Worse knee confidence, fear of movement, psychological readiness to return-to-sport and pain are associated with worse function after ACL reconstruction. Phys Ther Sport. 2020;41:1–8.PubMedCrossRef
36.
Herbert R. Research note: significance testing and hypothesis testing: meaningless, misleading and mostly unnecessary. J Physiother. 2019;65(3):178–81.PubMedCrossRef
37.
38.
Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348:g1687.PubMedCrossRef
39.
Ingelsrud LH, Granan LP, Terwee CB, Engebretsen L, Roos EM. Proportion of patients reporting acceptable symptoms or treatment failure and their associated KOOS values at 6 to 24 months after anterior cruciate ligament reconstruction: a study from the Norwegian knee ligament registry. Am J Sports Med. 2015;43(8):1902–7.PubMedCrossRef
40.
Kamper SJ, Maher CG, Mackay G. Global rating of change scales: a review of strengths and weaknesses and considerations for design. J Man Manip Ther. 2009;17(3):163–70.PubMedPubMedCentralCrossRef
41.
Kemp JL, Coburn SL, Jones DM, Crossley KM. The physiotherapy for Femoroacetabular impingement rehabilitation STudy (physioFIRST): a pilot randomized controlled trial. J Orthop Sports Phys Ther. 2018;48(4):307–15.PubMedCrossRef
42.
Kockum B, Heijne AI. Hop performance and leg muscle power in athletes: reliability of a test battery. Phys Ther Sport. 2015;16(3):222–7.PubMedCrossRef
43.
Kruse LM, Gray B, Wright RW. Rehabilitation after anterior cruciate ligament reconstruction: a systematic review. J Bone Joint Surg Am. 2012;94(19):1737–48.PubMedPubMedCentralCrossRef
44.
Kujala UM, Jaakkola LH, Koskinen SK, Taimela S, Hurme M, et al. Scoring of patellofemoral disorders. Arthroscopy. 1993;9(2):159–63.PubMedCrossRef
45.
Kvist J, Osterberg A, Gauffin H, Tagesson S, Webster K, et al. Translation and measurement properties of the Swedish version of ACL-return to sports after injury questionnaire. Scand J Med Sci Sports. 2013;23(5):568–75.PubMed
46.
Lafave MR, Hiemstra L, Kerslake S, Heard M, Buchko G. Validity, reliability, and responsiveness of the anterior cruciate ligament quality of life measure: a continuation of its overall validation. Clin J Sport Med. 2017;27(1):57–63.PubMedCrossRef
47.
Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004;10(2):307–12.PubMedCrossRef
48.
Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2012;10(1):28–55.PubMedCrossRef
49.
Mohtadi N. Development and validation of the quality of life outcome measure (questionnaire) for chronic anterior cruciate ligament deficiency. Am J Sports Med. 1998;26(3):350–9.PubMedCrossRef
50.
Moses B, Orchard J, Orchard J. Systematic review: annual incidence of ACL injury and surgery in various populations. Res Sports Med. 2012;20(3–4):157–79.PubMedCrossRef
51.
National Health Medical Research Council. National statement on ethical conduct in human research. Canberra: Australian Research Council; 2007.
52.
Paradowski PT, Bergman S, Sunden-Lundius A, Lohmander LS, Roos EM. Knee complaints vary with age and gender in the adult population. Population-based reference data for the Knee injury and Osteoarthritis Outcome Score (KOOS). BMC Musculoskelet Disord. 2006;7:38.PubMedPubMedCentralCrossRef
53.
Patterson B, Culvenor AG, Barton CJ, Guermazi A, Stefanik J, et al. Poor functional performance 1 year after ACL reconstruction increases the risk of early osteoarthritis progression. Br J Sports Med. 2020;54(9):546–53.PubMedCrossRef
54.
Patterson BE, Crossley KM, Perraton LG, Kumar AS, King MG, et al. Limb symmetry index on a functional test battery improves between one and five years after anterior cruciate ligament reconstruction, primarily due to worsening contralateral limb function. Phys Ther Sport. 2020;44:67–74.PubMedCrossRef
55.
Patterson BE, Culvenor AG, Barton CJ, Guermazi A, Stefanik JJ, et al. Patient-reported outcomes one to five years after anterior cruciate ligament reconstruction: the effect of combined injury and associations with osteoarthritis features defined on magnetic resonance imaging. Arthritis Care Res. 2020;72(3):412–22.CrossRef
56.
Patterson BE, Culvenor AG, Barton CJ, Guermazi A, Stefanik JJ, et al. Worsening knee osteoarthritis features on magnetic resonance imaging 1 to 5 years after anterior cruciate ligament reconstruction. Am J Sports Med. 2018;46(12):2873–83.PubMedPubMedCentralCrossRef
57.
Pinczewski LA, Lyman J, Salmon LJ, Russell VJ, Roe J, et al. A 10-year comparison of ACLR with hamstring tendon and patellar tendon autograft: a controlled, prospective trial. Am J Sports Med. 2007;35(4):564–74.PubMedCrossRef
58.
Pizzari T, McBurney H, Taylor NF, Feller JA. Adherence to anterior cruciate ligament rehabilitation: a qualitative analysis. J Sport Rehabil. 2002;11(2):90–102.CrossRef
59.
Pizzari T, Taylor NF, McBurney H, Feller JA. Adherence to rehabilitation after anterior cruciate ligament reconstructive surgery: implications for outcome. J Sport Rehabil. 2005;14(3):201–14.CrossRef
60.
Reid A, Birmingham TB, Stratford PW, Alcock GK, Giffin JR. Hop testing provides a reliable and valid outcome measure during rehabilitation after ACLR. Phys Ther. 2007;87(3):337–49.PubMedCrossRef
61.
Reinke EK, Spindler KP, Lorring D, Jones MH, Schmitz L, et al. Hop tests correlate with IKDC and KOOS at minimum of 2 years after primary ACL reconstruction. Knee Surg Sports Traumatol Arthrosc. 2011;19(11):1806–16.PubMedPubMedCentralCrossRef
62.
Risberg MA, Oiestad BE, Gunderson R, Aune AK, Engebretsen L, et al. Changes in knee osteoarthritis, symptoms, and function after anterior cruciate ligament reconstruction: a 20-year prospective follow-up study. Am J Sports Med. 2016;44(5):1215–24.PubMedCrossRef
63.
Roos EM, Lohmander LS. The knee injury and osteoarthritis outcome score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003;1:64.PubMedPubMedCentralCrossRef
64.
Slade SC, Dionne CE, Underwood M, Buchbinder R. Consensus on exercise reporting template (CERT): explanation and elaboration statement. Br J Sports Med. 2016;50(23):1428–37.PubMedCrossRef
65.
Spindler KP, Huston LJ, Chagin KM, Kattan MW, Reinke EK, et al. Ten-year outcomes and risk factors after anterior cruciate ligament reconstruction: a MOON longitudinal prospective cohort study. Am J Sports Med. 2018;46(4):815–25.PubMedCrossRef
66.
Sritharan P, Schache AG, Culvenor AG, Perraton LG, Bryant AL, et al. Between-limb differences in patellofemoral joint forces during running 12 to 24 months after unilateral ACL reconstruction. Am J Sports Med. 2020;48(7):1711–9.PubMedCrossRef
67.
Tan JM, Menz HB, Crossley KM, Munteanu SE, Hart HF, et al. The efficacy of foot orthoses in individuals with patellofemoral osteoarthritis: a randomised feasibility trial. Pilot Feasibility Studies. 2019;5(1):90.PubMedCrossRefPubMedCentral
68.
Thorstensson CA, Petersson IF, Jacobsson LT, Boegard TL, Roos EM. Reduced functional performance in the lower extremity predicted radiographic knee osteoarthritis five years later. Ann Rheum Dis. 2004;63(4):402–7.PubMedPubMedCentralCrossRef
69.
Toigo M, Boutellier U. New fundamental resistance exercise determinants of molecular and cellular muscle adaptations. Eur J Appl Physiol. 2006;97(6):643–63.PubMedCrossRef
70.
71.
Tubach F, Dougados M, Falissard B, Baron G, Logeart I, et al. Feeling good rather than feeling better matters more to patients. Arthritis Rheum. 2006;55(4):526–30.PubMedCrossRef
72.
van Melick N, van Cingel RE, Brooijmans F, Neeter C, van Tienen T, et al. Evidence-based clinical practice update: practice guidelines for anterior cruciate ligament rehabilitation based on a systematic review and multidisciplinary consensus. Br J Sports Med. 2016;50(24):1506–15.PubMedCrossRef
73.
Walker A, Hing W, Lorimer A. The Influence, Barriers to and Facilitators of Anterior Cruciate Ligament Rehabilitation Adherence and Participation: a Scoping Review. Sports Med Open. 2020;6(1):32.PubMedPubMedCentralCrossRef
74.
Webster KE, Feller JA, Lambros C. Development and preliminary validation of a scale to measure the psychological impact of returning to sport following anterior cruciate ligament reconstruction surgery. Phys Ther Sport. 2008;9(1):9–15.PubMedCrossRef
75.
Webster KE, Nagelli CV, Hewett TE, Feller JA. Factors associated with psychological readiness to return to sport after anterior cruciate ligament reconstruction surgery. Am J Sports Med. 2018;46(7):1545–50.PubMedPubMedCentralCrossRef
76.
Whittaker JL, Roos EM. A pragmatic approach to prevent post-traumatic osteoarthritis after sport or exercise-related joint injury. Best Pract Res Clin Rheumatol. 2019;33(1):158–71.PubMedCrossRef
77.
Wilson K, Brookfield D. Effect of goal setting on motivation and adherence in a six-week exercise program. Int J Sport Exerc Psychol. 2009;7(1):89–100.CrossRef
78.
Wright RW, Gill CS, Chen L, Brophy RH, Matava MJ, et al. Outcome of revision anterior cruciate ligament reconstruction: a systematic review. J Bone Joint Surg Am. 2012;94(6):531–6.PubMedPubMedCentralCrossRef
79.
Xergia SA, Pappas E, Zampeli F, Georgiou S, Georgoulis AD. Asymmetries in functional hop tests, lower extremity kinematics, and isokinetic strength persist 6 to 9 months following anterior cruciate ligament reconstruction. J Orthop Sports Phys Ther. 2013;43(3):154–62.PubMedCrossRef
Metadata
Title
Exercise-therapy and education for individuals one year after anterior cruciate ligament reconstruction: a pilot randomised controlled trial
Authors
Brooke E. Patterson
Christian J. Barton
Adam G. Culvenor
Randall L. Cooper
Kay M. Crossley
Publication date
01-12-2021
Publisher
BioMed Central
Published in
BMC Musculoskeletal Disorders / Issue 1/2021
Electronic ISSN: 1471-2474
DOI
https://doi.org/10.1186/s12891-020-03919-6

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