Pain-guided activity modification during treatment for patellar tendinopathy: a feasibility and pilot randomized clinical trial

Andrew L Sprague, Christian Couppé, Ryan T Pohlig, Lynn Snyder-Mackler, Karin Grävare Silbernagel, Andrew L Sprague, Christian Couppé, Ryan T Pohlig, Lynn Snyder-Mackler, Karin Grävare Silbernagel

Abstract

Background: Activity modification is a key component of patellar tendinopathy treatment but there is a lack of evidence guiding activity modification prescription. Use of activity modification in treatment studies has varied widely and the impact of those recommendations has not been directly investigated or compared. The purpose of this study was to assess (1) the feasibility of using pain-guided activity modification during treatment for patellar tendinopathy and (2) if our outcome measures are responsive to changes in tendon health over the course of treatment.

Methods: This was an unblinded, randomized two-arm pilot and feasibility study randomized clinical trial with parallel assignment, conducted in Newark, DE. Individuals between the ages of 16 and 40 years old with patellar tendinopathy were included. Participants were randomly assigned to a pain-guided activity (PGA) or pain-free activity (PFA) group using a spreadsheet-based randomization scheme. All participants received standardized treatment using a modified version of the heavy-slow resistance protocol 3×/week for 12 weeks. For the first 6 weeks, the PGA group used the Pain-Monitoring Model to guide activity outside of treatment and the PFA group was restricted from running, jumping, or activities that provoked their patellar tendon pain. Feasibility outcomes included recruitment, enrollment, randomization, compliance, and retention percentages. Clinical evaluations were conducted at baseline, 6, and 12 weeks to assess symptom severity, psychological factors, tendon morphology and mechanical properties, lower extremity function, and quadriceps muscle performance.

Results: In a ~ 13-month period, 108 individuals were screened, 47/108 (43.5%) were eligible for participation, and 15/47 (32.0%) of those were enrolled (9 PGA, 6 PFA). The recruitment rate was 1.15 participants/month. The mean ± SD compliance with treatment was PGA: 86.1 ± 13.0% and PFA: 67.1 ± 30.7%. There was one missed evaluation session and two adverse events, which were not due to study interventions. Changes exceeding the smallest detectable change were observed for at least one outcome in each domain of tendon health.

Conclusions: Use of pain-guided activity modification during exercise therapy for patellar tendinopathy was found to be feasible, and the proposed outcome measures appropriate. Computer-based allocation concealment, blinding of evaluators, and greater recruitment of high-level athletes should be implemented in future trials.

Trial registration: ClinicalTrials.gov identifier: NCT03694730 . Registered 3rd of October, 2018.

Keywords: Activity modification; Elastography; Exercise therapy; Jumper’s Knee; Patellar tendinopathy; Tendon loading; patellar tendinitis.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Pain-monitoring model
Fig. 2
Fig. 2
Heavy-slow resistance training parameters for the a squat, b knee extension, and c leg press
Fig. 3
Fig. 3
CONSORT flowchart for recruitment and randomization
Fig. 4
Fig. 4
Estimated marginal means for a VISA-P and b palpatory pain for the pooled samples and groups. Note: Statistical significance is for the pooled sample only and Y-axis is truncated
Fig. 5
Fig. 5
Estimated marginal means for KOOS-QOL for the pooled sample and groups. Note: Statistical significance is for the pooled sample only and Y-axis is truncated
Fig. 6
Fig. 6
Estimated marginal means for the a TSK-17 and b DASS-21 for the pooled sample and groups. Note: Statistical significance is for the pooled sample only and the Y-axis is truncated
Fig. 7
Fig. 7
Estimated marginal means for a tendon thickness and b cross-sectional area for the pooled sample and groups. Note: Y-axis is truncated
Fig. 8
Fig. 8
Estimated marginal means for a shear modulus and b viscosity for the pooled sample and groups. Note: Y-axis truncated
Fig. 9
Fig. 9
Estimated marginal means for a CMJ and b drop CMJ height for the pooled sample and groups. Note: Statistical significance is for the pooled sample only and the Y-axis is truncated
Fig. 10
Fig. 10
Estimated marginal means for a knee extension MVIC and b central activation ratio for the pooled sample and groups. Note: Y-axis is truncated

References

    1. Magnusson SP, Langberg H, Kjaer M. The pathogenesis of tendinopathy: balancing the response to loading. Nat Rev Rheumatol 2010;6(5):262–268. Available from:
    1. Malliaras P, Cook J, Purdam C, Rio E. Patellar Tendinopathy: clinical diagnosis, load management, and advice for challenging case presentations. J Orthop Sport Phys Ther 2015;45(11):887–898. Available from:
    1. Larsson MEH, Käll I, Nilsson-Helander K. Treatment of patellar tendinopathy—a systematic review of randomized controlled trials. Knee Surg Sport Traumatol Arthrosc. 2012;20(8):1632–1646. [cited 2017 Dec 13] Available from:
    1. van Rijn D, van den Akker-Scheek I, Steunebrink M, Diercks RL, Zwerver J, van der Worp H. Comparison of the effect of 5 different treatment options for managing patellar tendinopathy: a secondary analysis. Clin J Sport Med. 2019;29(3):181–7. Available from:
    1. Purdam CR, Jonsson P, Alfredson H, Lorentzon R, Cook JL, Khan KM. A pilot study of the eccentric decline squat in the management of painful chronic patellar tendinopathy. Br J Sports Med 2004;38(4):395–397. Available from:
    1. Bahr R, Fossan B, Løken S, Engebretsen L. Surgical treatment compared with eccentric training for patellar tendinopathy (Jumperʼs Knee) J Bone Jt Surg. 2006;88(8):1689–1698. doi: 10.2106/00004623-200608000-00001.
    1. Frohm A, Saartok T, Halvorsen K, Renström P. Eccentric treatment for patellar tendinopathy: a prospective randomised short-term pilot study of two rehabilitation protocols. Br J Sports Med. 2007;41(7):e7. doi: 10.1136/bjsm.2006.032599.
    1. Visnes H, Hoksrud A, Cook J, Bahr R. No effect of eccentric training on jumper’s knee in volleyball players during the competitive season: a randomized clinical trial. Clin J Sport Med. 2005;15(4):227–234. doi: 10.1097/01.jsm.0000168073.82121.20.
    1. van Ark M, Cook JL, Docking SI, Zwerver J, Gaida JE, van den Akker-Scheek I, et al. Do isometric and isotonic exercise programs reduce pain in athletes with patellar tendinopathy in-season? A randomised clinical trial. J Sci Med Sport 2016;19(9):702–706. Available from:
    1. Rio E, Purdam C, Girdwood M, Cook J. Isometric exercise to reduce pain in patellar tendinopathy in-season; is it effective “on the road?” Clin J Sport Med. 2019;29(3):188–92. Available from:
    1. Kongsgaard M, Kovanen V, Aagaard P, Doessing S, Hansen P, Laursen AH, et al. Corticosteroid injections, eccentric decline squat training and heavy slow resistance training in patellar tendinopathy. Scand J Med Sci Sports. 2009;19(6):790–802. doi: 10.1111/j.1600-0838.2009.00949.x.
    1. Kongsgaard M, Qvortrup K, Larsen J, Aagaard P, Doessing S, Hansen P, et al. Fibril morphology and tendon mechanical properties in patellar tendinopathy: effects of heavy slow resistance training. Am J Sports Med. 2010;38(4):749–756. doi: 10.1177/0363546509350915.
    1. Leddy MH, Lambert MJ, Ogles BM. Psychological consequences of athletic injury among high-level competitors. Res Q Exerc Sport. 1994;65(4):347–354. doi: 10.1080/02701367.1994.10607639.
    1. Thomeé R. A comprehensive treatment approach for patellofemoral pain syndrome in young women. Phys Ther. 1997;77(12):1690–1703. doi: 10.1093/ptj/77.12.1690.
    1. Silbernagel KG, Thomeé R, Eriksson BI, Karlsson J. Continued sports activity, using a pain-monitoring model, during rehabilitation in patients with Achilles tendinopathy: a randomized controlled study. Am J Sports Med 2007;35(6):897–906. Available from:
    1. Abbott JH. The distinction between randomized clinical trials (RCTs) and preliminary feasibility and pilot studies: what they are and are not. J Orthop Sport Phys Ther 2014;44(8):555–558. Available from:
    1. Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, et al. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot feasibility Stud. 2016;2(1):64. doi: 10.1186/s40814-016-0105-8.
    1. Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c869. doi: 10.1136/bmj.c869.
    1. Scott A, Squier K, Alfredson H, Bahr R, Cook JL, Coombes B, et al. ICON 2019: international scientific tendinopathy symposium consensus: clinical terminology. Br J Sports Med. 2019;bjsports-2019-100885. Available from:
    1. 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):377–381. doi: 10.1016/j.jbi.2008.08.010.
    1. Visentini PJ, Khan KM, Cook JL, Kiss ZS, Harcourt PR, Wark JD. The VISA score: an index of severity of symptoms in patients with jumper’s knee (patellar tendinosis). Victorian institute of sport tendon study group. J Sci Med Sport. 1998;1(1):22–28. doi: 10.1016/S1440-2440(98)80005-4.
    1. Hernandez-Sanchez S, Hidalgo MD. Gomez a. Responsiveness of the VISA-P scale for patellar tendinopathy in athletes. Br J Sports Med. 2012;3(6):453–457. doi: 10.1136/bjsports-2012-091163.
    1. Farrar JT, Young JP, LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001;94(2):149–158. doi: 10.1016/S0304-3959(01)00349-9.
    1. Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee injury and osteoarthritis outcome score (KOOS)—development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998;28(2):88–96.
    1. Vlaeyen JWSS, Kole-Snijders AMJJ, Boeren RGBB, van Eek H. Fear of movement/(re)injury in chronic low back pain and its relation to behavioral performance. Pain. 1995;62(3):363–372. doi: 10.1016/0304-3959(94)00279-N.
    1. French DJ, France CR, Vigneau FF, French JA, Evans RT. Fear of movement/(re)injury in chronic pain: A psychometric assessment of the original English version of the Tampa scale for kinesiophobia (TSK) Pain. 2007;127(1–2):42–51. doi: 10.1016/j.pain.2006.07.016.
    1. Silbernagel KG, Brorsson A, Lundberg M. The majority of patients with Achilles tendinopathy recover fully when treated with exercise alone: a 5-year follow-up. Am J Sports Med. 2011;39(3):607–613. doi: 10.1177/0363546510384789.
    1. Sprague AL, Silbernagel KG. High prevalence of kinesiophobia in patellar and quadriceps tendinopathies. Washington, D.C: APTA Combined Sections Meeting; 2019.
    1. Sullivan MJL, Bishop SR, Pivik J. The pain catastrophizing scale: development and validation. Psychol Assess. 1995;7(4):524–32.
    1. Antony MM, Bieling PJ, Cox BJ, Enns MW, Swinson RP. Psychometric properties of the 42-item and 21-item versions of the Depression Anxiety Stress Scales in clinical groups and a community sample. Psychol Assess 1998;10(2):176–181. Available from:
    1. De Francisco C, Arce C, del Pilar Vílchez M, Vales Á. Antecedents and consequences of burnout in athletes: Perceived stress and depression. Int J Clin Heal Psychol. 2016;16(3):239–246. Available from:
    1. Drew MK, Vlahovich N, Hughes D, Appaneal R, Peterson K, Burke L, et al. A multifactorial evaluation of illness risk factors in athletes preparing for the Summer Olympic Games. J Sci Med Sport 2017;20(8):745–750. Available from:
    1. Martinoli C. Musculoskeletal ultrasound: technical guidelines. Insights Imaging 2010;1(3):99–141. Available from:
    1. Corrigan P, Zellers JA, Balascio P, Silbernagel KG, Cortes DH. Quantification of mechanical properties in healthy Achilles tendon using continous shear wave elastography: a reliability and validation study. Ultrasound Med Biol. 2019;45(7):1574–1585. doi: 10.1016/j.ultrasmedbio.2019.03.015.
    1. Cortes DH, Suydam SM, Silbernagel KG, Buchanan TS, Elliott DM. Continuous shear wave elastography: a new method to measure viscoelastic properties of tendons in vivo. Ultrasound Med Biol. 2015;41(6):1518–1529. doi: 10.1016/j.ultrasmedbio.2015.02.001.
    1. Silbernagel KG, Gustavsson A, Thomeé R, Karlsson J. Evaluation of lower leg function in patients with Achilles tendinopathy. Knee Surg Sport Traumatol Arthrosc. 2006;14(11):1207–1217. Available from:
    1. Murtagh CF, Stubbs M, Vanrenterghem J, Boyle AO, Morgans R. Patellar tendon properties distinguish elite from non-elite soccer players and are related to peak horizontal but not vertical power. Eur J Appl Physiol. 2018;0(0):0. Available from:
    1. Lewek MD, Rudolph KS, Snyder-Mackler L. Quadriceps femoris muscle weakness and activation failure in patients with symptomatic knee osteoarthritis. J Orthop Res. 2004;22(1):110–115. doi: 10.1016/S0736-0266(03)00154-2.
    1. Hart JM, Pietrosimone B, Hertel J, Ingersoll CD. Quadriceps activation following knee injuries: a systematic review. J Athl Train. 2010;45(1):87–97. doi: 10.4085/1062-6050-45.1.87.
    1. Norte GE, Frye JL, Hart JM. Reliability of the superimposed-burst technique in patients with patellofemoral pain: A technical report. J Athl Train. 2015;50(11):1207–11. doi: 10.4085/1062-6050-50.10.03.
    1. Park J, Hopkins JT. Within-and between-session reliability of the maximal voluntary knee extension torque and activation. Int J Neurosci 2013;123(1):55–59. Available from:
    1. Lynch AD, Logerstedt DS, Axe MJ, Snyder-Mackler L. Quadriceps activation failure after anterior cruciate ligament rupture is not mediated by knee joint effusion. J Orthop Sport Phys Ther 2012;42(6):502–510. Available from:
    1. Pietrosimone BG, Hertel J, Ingersoll CD, Hart JM, Saliba SA. Voluntary quadriceps activation deficits in patients with tibiofemoral osteoarthritis: a meta-analysis. Vol. 3, PM and R. 2011. p. 153–62.
    1. Stackhouse SK, Dean JC, Lee SCK, Binder-MacLeod SA. Measurement of central activation failure of the quadriceps femoris in healthy adults. Muscle Nerve. 2000;23(11):1706–1712. doi: 10.1002/1097-4598(200011)23:11<1706::AID-MUS6>;2-B.
    1. Mentiplay BF, Perraton LG, Bower KJ, Adair B, Pua YH, Williams GP, et al. Assessment of lower limb muscle strength and power using hand-held and fixed dynamometry: A reliability and validity study. PLoS One. 2015;10(10):1–18. doi: 10.1371/journal.pone.0140822.
    1. Team RC. R: A Language and Environment for Statistical Computing [Internet] Vienna, Austria: R Foundation for Statistical Computing; 2019.
    1. Rs T. RStudio: Integrated Development Environment for R [Internet] Boston, MA: RStudio, Inc.; 2019.
    1. McLean RA, Sanders WL, Stroup WW. A unified approach to mixed linear models. Am Stat. 1991;45(1):54.
    1. Laird NM, Ware JH. Random-effects models for longitudinal data. Biometrics. 1982 ;38(4):963. Available from:
    1. Elkins MR, Moseley AM. Intention-to-treat analysis. J Physiother. 2015;61(3):165–167. doi: 10.1016/j.jphys.2015.05.013.
    1. Koch K-R. Mixed models. In 1990. p. 109–21. Available from:
    1. Alghadir AH, Anwer S, Iqbal A, Iqbal ZA. Test-retest reliability, validity, and minimum detectable change of visual analog, numerical rating, and verbal rating scales for measurement of osteoarthritic knee pain. J Pain Res. 2018;11:851–856. doi: 10.2147/JPR.S158847.
    1. Collins NJ, Misra D, Felson DT, Crossley KM, Roos EM. Measures of knee function: International knee documentation committee (IKDC) Subjective knee evaluation form, knee injury and osteoarthritis outcome score (KOOS), Knee injury and osteoarthritis outcome score physical function short form (KOOS-PS), Knee Ou. Arthritis Care Res (Hoboken) 2011;63(Suppl 1(4)):S208–S228. doi: 10.1002/acr.20632.
    1. Zhong B. How to calculate sample size in randomized controlled trial? J Thorac Dis. 2009;1(1):51–54.
    1. Vickers AJ. How to randomize. J Soc Integr Oncol. 2006;4(4):194–198. doi: 10.2310/7200.2006.023.
    1. Zwerver J, Bredeweg SW, van den Akker-Scheek I. Prevalence of Jumper’s knee among nonelite athletes from different sports: a cross-sectional survey. Am J Sports Med. 2011;39(9):1984–1988. doi: 10.1177/0363546511413370.
    1. Lian ØB, Engebretsen L, Bahr R. Prevalence of jumper’s knee among elite athletes from different sports: a cross-sectional study. Am J Sports Med. 2005;33(4):561–567. doi: 10.1177/0363546504270454.
    1. Rio E, Van Ark M, Docking S, Moseley GL, Kidgell D, Gaida JE, et al. Isometric contractions are more analgesic than isotonic contractions for patellar tendon pain: an in-season randomized clinical trial. Clin J Sport Med. 2017;27(3):253–259. doi: 10.1097/JSM.0000000000000364.
    1. Gaida J, Praet S, Burke L, Lovell G, Waddington G, Vlahovich N, et al. Oral supplementation of specific collagen peptides combined with calf-strengthening exercises enhances function and reduces pain in achilles tendinopathy patients. Nutrients. 2019;11(1):76. doi: 10.3390/nu11010076.
    1. Dimitrios S, Pantelis M, Kalliopi S. Comparing the effects of eccentric training with eccentric training and static stretching exercises in the treatment of patellar tendinopathy. A controlled clinical trial. Clin Rehabil. 2012;26(5):423–430. doi: 10.1177/0269215511411114.
    1. Riel H, Olesen JL, Jensen MB, Vicenzino B, Rathleff MS. Heavy-slow resistance training in addition to an ultrasound-guided corticosteroid injection for individuals with plantar fasciopathy: a feasibility study. Pilot Feasibility Stud. 2019;5(1):1–9. doi: 10.1186/s40814-019-0489-3.
    1. Moseley GL. Do training diaries affect and reflect adherence to home programs? Arthritis Care Res. 2006;55(4):662–664. doi: 10.1002/art.22086.
    1. Lovibond SH, Lovibond PF. Manual for the depression anxiety stress scales (2nd Ed). Sydney:Psychology Foundation of Australia. 1995.
    1. Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression anxiety stress scales (DASS) with the beck depression and anxiety inventories. Behav Res Ther. 1995;33(3):335–343. doi: 10.1016/0005-7967(94)00075-U.
    1. Lamont-Mills A, Christensen SA. Athletic identity and its relationship to sport participation levels. J Sci Med Sport. 2006;9(6):472–478. doi: 10.1016/j.jsams.2006.04.004.
    1. Vlaeyen JWS, Kole-Snijders AMJ, Rotteveel AM, Ruesink R, PHTG H. The role of fear of movement/(re)injury in pain disability. J Occup Rehabil. 1995;5(4):235–252. doi: 10.1007/BF02109988.
    1. Stone AA, Shiffman S, Schwartz JE, Broderick JE, Hufford MR. Patient compliance with paper and electronic diaries. Control Clin Trials. 2003;24(2):182–199. doi: 10.1016/S0197-2456(02)00320-3.

Source: PubMed

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

3
Abonnere