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Trials
Published in: Trials 1/2024

Open Access 01-12-2024 | Tendinopathy | Study protocol

To allow or avoid pain during shoulder rehabilitation exercises for patients with chronic rotator cuff tendinopathy-Study protocol for a randomized controlled trial (the PASE trial)

Authors: Birgitte Hougs Kjær, Ann M. Cools, Finn E. Johannsen, Jeanette Trøstrup, Theresa Bieler, Volkert Siersma, Peter S. Magnusson

Published in: Trials | Issue 1/2024

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Abstract

Background

Rotator cuff (RC) tendinopathy is the most reported shoulder disorder in the general population with highest prevalence in overhead athletes and adult working-age population. A growing body of evidence support exercise therapy as an effective intervention, but to date there are no prospective randomized controlled trials addressing pain as an intervention variable.

Methods

A single-site, prospective, pragmatic, assessor-blinded randomized controlled superiority trial. Eighty-four patients aged 18–55 years with chronic (symptom duration over 3 months) RC tendinopathy are randomized 1:1 to receive shoulder exercise during which pain is either allowed or avoided. The intervention period lasts 26 weeks. During that period, participants in both groups are offered 8 individual on-site sessions with an assigned sports physiotherapist. Participants perform home exercises and are provided with a pain and exercise logbook and asked to report completed home-based exercise sessions and reasons for not completing sessions (pain or other reasons). Patients are also asked to report load and the number of sets and repetitions per sets for each exercise session. The logbooks are collected continuously throughout the intervention period. The primary and secondary outcomes are obtained at baseline, 6 weeks, 26 weeks, and 1 year after baseline. The primary outcome is patient-reported pain and disability using the Shoulder PAin and Disability Index (SPADI). Secondary outcomes are patient-reported pain and disability using Disability Arm Shoulder and Hand short-form (Quick DASH), and shoulder pain using Numeric Pain Rating Scale. Objective outcomes are shoulder range of motion, isometric shoulder muscle strength, pain sensitivity, working ability, and structural changes in the supraspinatus tendon and muscle using ultrasound.

Discussion

The results of this study will contribute knowledge about the treatment strategies for patients with RC tendinopathy and help physiotherapists in clinical decision-making. This is the first randomized controlled trial comparing the effects of allowing pain versus avoiding pain during shoulder exercises in patients with chronic RC tendinopathy. If tolerating pain during and after exercise proves to be effective, it will potentially expand our understanding of “exercising into pain” for this patient group, as there is currently no consensus.

Trial registration

ClinicalTrials.gov NCT05124769. Registered on August 11, 2021.
Appendix
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Literature
1.
Luime JJ, Koes BW, Hendriksen IJ, Burdorf A, Verhagen AP, Miedema HS, et al. Prevalence and incidence of shoulder pain in the general population; a systematic review. Scand J Rheumatol. 2004;33(2):73–81.PubMedCrossRef
2.
Lucas J, van Doorn P, Hegedus E, Lewis J, van der Windt D. A systematic review of the global prevalence and incidence of shoulder pain. BMC Musculoskelet Disord. 2022;23(1):1073.PubMedPubMedCentralCrossRef
3.
Lewis JS. Rotator cuff tendinopathy/subacromial impingement syndrome: is it time for a new method of assessment? Br J Sports Med. 2009;43(4):259–64.PubMedCrossRef
4.
Malliaras P, Johnston R, Street G, Littlewood C, Bennell K, Haines T, et al. The efficacy of higher versus lower dose exercise in rotator cuff tendinopathy: a systematic review of randomized controlled trials. Arch Phys Med Rehabil. 2020;101(10):1822–34.PubMedCrossRef
5.
Cools AM, Johansson FR, Borms D, Maenhout A. Prevention of shoulder injuries in overhead athletes: a science-based approach. Braz J Phys Ther. 2015;19:331–9.PubMedPubMedCentralCrossRef
6.
Littlewood C, May S, Walters S. Epidemiology of rotator cuff tendinopathy: a systematic review. Shoulder Elbow. 2017;5(4):256–65.CrossRef
7.
Huisstede BM, Wijnhoven HA, Bierma-Zeinstra SM, Koes BW, Verhaar JA, Picavet S. Prevalence and characteristics of complaints of the arm, neck, and/or shoulder (CANS) in the open population. Clin J Pain. 2008;24(3):253–9.PubMedCrossRef
8.
Kuijpers T, van der Windt DA, van der Heijden GJ, Twisk JW, Vergouwe Y, Bouter LM. A prediction rule for shoulder pain related sick leave: a prospective cohort study. BMC Musculoskelet Disord. 2006;7:97.PubMedPubMedCentralCrossRef
9.
Lotters F, Meerding WJ, Burdorf A. Reduced productivity after sickness absence due to musculoskeletal disorders and its relation to health outcomes. Scand J Work Environ Health. 2005;31(5):367–74.PubMedCrossRef
10.
Lewis JS, Raza SA, Pilcher J, Heron C, Poloniecki JD. The prevalence of neovascularity in patients clinically diagnosed with rotator cuff tendinopathy. BMC Musculoskelet Disord. 2009;10:163.PubMedPubMedCentralCrossRef
11.
12.
Lewis J, McCreesh K, Roy JS, Ginn K. Rotator cuff tendinopathy: navigating the diagnosis-management conundrum. J Orthop Sports Phys Ther. 2015;45(11):923–37.PubMedCrossRef
13.
Littlewood C, Ashton J, Chance-Larsen K, May S, Sturrock B. Exercise for rotator cuff tendinopathy: a systematic review. Physiotherapy. 2012;98(2):101–9.PubMedCrossRef
14.
Hegedus EJ, Cook C, Lewis J, Wright A, Park JY. Combining orthopedic special tests to improve diagnosis of shoulder pathology. Phys Ther Sport. 2015;16(2):87–92.PubMedCrossRef
15.
Hegedus EJ, Goode AP, Cook CE, Michener L, Myer CA, Myer DM, et al. Which physical examination tests provide clinicians with the most value when examining the shoulder? Update of a systematic review with meta-analysis of individual tests. Br J Sports Med. 2012;46(14):964–78.PubMedCrossRef
16.
McClure PW, Michener LA. Staged Approach for Rehabilitation Classification: Shoulder Disorders (STAR-Shoulder). Phys Ther. 2015;95(5):791–800.PubMedCrossRef
17.
Requejo-Salinas N, Lewis J, Michener LA, La Touche R, Fernandez-Matias R, Tercero-Lucas J, et al. International physical therapists consensus on clinical descriptors for diagnosing rotator cuff related shoulder pain: a Delphi study. Braz J Phys Ther. 2022;26(2):100395.PubMedPubMedCentralCrossRef
18.
Littlewood C, May S, Walters S. A review of systematic reviews of the effectiveness of conservative interventions for rotator cuff tendinopathy. Should Elb. 2013;5(3):151–67.CrossRef
19.
Littlewood C, Malliaras P, Chance-Larsen K. Therapeutic exercise for rotator cuff tendinopathy: a systematic review of contextual factors and prescription parameters. Int J Rehabil Res. 2015;38(2):95–106.PubMedCrossRef
20.
Pieters L, Lewis J, Kuppens K, Jochems J, Bruijstens T, Joossens L, et al. An Update of Systematic Reviews Examining the Effectiveness of Conservative Physical Therapy Interventions for Subacromial Shoulder Pain. J Orthop Sports Phys Ther. 2020;50(3):131–41.PubMedCrossRef
21.
Magnusson SP, Kjaer M. The impact of loading, unloading, ageing and injury on the human tendon. J Physiol. 2019;597(5):1283–98.PubMedCrossRef
22.
Eliasson P, Couppe C, Lonsdale M, Svensson RB, Neergaard C, Kjaer M, et al. Ruptured human Achilles tendon has elevated metabolic activity up to 1 year after repair. Eur J Nucl Med Mol Imaging. 2016;43(10):1868–77.PubMedCrossRef
23.
Eliasson P, Agergaard AS, Couppe C, Svensson R, Hoeffner R, Warming S, et al. The Ruptured Achilles Tendon Elongates for 6 Months After Surgical Repair Regardless of Early or Late Weightbearing in Combination With Ankle Mobilization: A Randomized Clinical Trial. Am J Sports Med. 2018;46(10):2492–502.PubMedCrossRef
24.
Conti M, Garofalo R, Delle Rose G, Massazza G, Vinci E, Randelli M, et al. Post-operative rehabilitation after surgical repair of the rotator cuff. La Chirurgia degli organi di movimento. 2009;93(Suppl 1):S55-63.PubMed
25.
Maenhout AG, Mahieu NN, De Muynck M, De Wilde LF, Cools AM. Does adding heavy load eccentric training to rehabilitation of patients with unilateral subacromial impingement result in better outcome? A randomized, clinical trial. Knee Surg Sports Traumatol Arthrosc. 2013;21(5):1158–67.PubMedCrossRef
26.
Lombardi I Jr, Magri AG, Fleury AM, Da Silva AC, Natour J. Progressive resistance training in patients with shoulder impingement syndrome: a randomized controlled trial. Arthritis Rheum. 2008;59(5):615–22.PubMedCrossRef
27.
Ingwersen KG, Jensen SL, Sorensen L, Jorgensen HR, Christensen R, Sogaard K, et al. Three months of progressive high-load versus traditional low-load strength training among patients with rotator cuff tendinopathy: primary results from the double-blind randomized controlled RoCTEx trial. Orthop J Sports Med. 2017;5(8):2325967117723292.PubMedPubMedCentralCrossRef
28.
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.PubMedCrossRef
29.
Beyer R, Kongsgaard M, Hougs Kjaer B, Ohlenschlaeger T, Kjaer M, Magnusson SP. Heavy slow resistance versus eccentric training as treatment for achilles tendinopathy: a randomized controlled trial. Am J Sports Med. 2015;43(7):1704–11.PubMedCrossRef
30.
Thomee R. A comprehensive treatment approach for patellofemoral pain syndrome in young women. Phys Ther. 1997;77(12):1690–703.PubMedCrossRef
31.
Silbernagel KG, Thomee 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.PubMedCrossRef
32.
Smith BE, Hendrick P, Smith TO, Bateman M, Moffatt F, Rathleff MS, et al. Should exercises be painful in the management of chronic musculoskeletal pain? A systematic review and meta-analysis. Br J Sports Med. 2017;51(23):1679–87.PubMedCrossRef
33.
Smith BE, Hendrick P, Bateman M, Holden S, Littlewood C, Smith TO, et al. Musculoskeletal pain and exercise-challenging existing paradigms and introducing new. Br J Sports Med. 2019;53(14):907–12.PubMedCrossRef
34.
Ludewig PM, Borstad JD. Effects of a home exercise programme on shoulder pain and functional status in construction workers. Occup Environ Med. 2003;60(11):841–9.PubMedPubMedCentralCrossRef
35.
Baskurt Z, Baskurt F, Gelecek N, Ozkan MH. The effectiveness of scapular stabilization exercise in the patients with subacromial impingement syndrome. J Back Musculoskelet Rehabil. 2011;24(3):173–9.PubMedCrossRef
36.
Yiasemides R, Halaki M, Cathers I, Ginn KA. Does passive mobilization of shoulder region joints provide additional benefit over advice and exercise alone for people who have shoulder pain and minimal movement restriction? Phys Ther. 2011;91(2):178–89.PubMedCrossRef
37.
Engebretsen K, Grotle M, Bautz-Holter E, Ekeberg OM, Juel NG, Brox JI. Supervised exercises compared with radial extracorporeal shock-wave therapy for subacromial shoulder pain: 1-year results of a single-blind randomized controlled trial. Phys Ther. 2011;91(1):37–47.PubMedCrossRef
38.
Engebretsen K, Grotle M, Bautz-Holter E, Sandvik L, Juel NG, Ekeberg OM, et al. Radial extracorporeal shockwave treatment compared with supervised exercises in patients with subacromial pain syndrome: single blind randomised study. BMJ. 2009;339:b3360.PubMedPubMedCentralCrossRef
39.
Osteras H, Myhr G, Haugerud L, Torstensen TA. Clinical and MRI findings after high dosage medical exercise therapy in patients with long lasting subacromial pain syndrome: a case series on six patients. J Bodyw Mov Ther. 2010;14(4):352–60.PubMedCrossRef
40.
Osteras H, Aamodt A. Regarding, “Exercise in the treatment of rotator cuff impingement: a systematic review and a synthesized evidence-based rehabilitation protocol.” J Shoulder Elbow Surg. 2009;18(4):e33 (author reply e-4).PubMedCrossRef
41.
Osteras N, Gulbrandsen P, Benth JS, Hofoss D, Brage S. Implementing structured functional assessments in general practice for persons with long-term sick leave: a cluster randomised controlled trial. BMC Fam Pract. 2009;10:31.PubMedPubMedCentralCrossRef
42.
Kromer TO, de Bie RA, Bastiaenen CH. Physiotherapy in patients with clinical signs of shoulder impingement syndrome: a randomized controlled trial. J Rehabil Med. 2013;45(5):488–97.PubMedCrossRef
43.
Littlewood C, Malliaras P, Mawson S, May S, Walters SJ. Self-managed loaded exercise versus usual physiotherapy treatment for rotator cuff tendinopathy: a pilot randomised controlled trial. Physiotherapy. 2014;100(1):54–60.PubMedCrossRef
44.
Littlewood C, Malliaras P, Mawson S, May S, Walters S. Patients with rotator cuff tendinopathy can successfully self-manage, but with certain caveats: a qualitative study. Physiotherapy. 2014;100(1):80–5.PubMedCrossRef
45.
Littlewood C, Malliaras P, Bateman M, Stace R, May S, Walters S. The central nervous system–an additional consideration in “rotator cuff tendinopathy” and a potential basis for understanding response to loaded therapeutic exercise. Man Ther. 2013;18(6):468–72.PubMedCrossRef
46.
Vila-Dieguez O, Heindel MD, Awokuse D, Kulig K, Michener LA. Exercise for rotator cuff tendinopathy: Proposed mechanisms of recovery. Shoulder Elbow. 2023;15(3):233–49.PubMedCrossRef
47.
Alaiti RK, Saragiotto BT, Fukusawa L, Rabelo DAN, de Oliveira AS. Choosing what works for whom towards a better use of mechanistic knowledge in clinical practice. Arch Physiother. 2021;11(1):26.PubMedPubMedCentralCrossRef
48.
VanderWeele TJ. Explanation in causal inference: developments in mediation and interaction. Int J Epidemiol. 2016;45(6):1904–8.PubMedPubMedCentral
49.
50.
Turner JA, Holtzman S, Mancl L. Mediators, moderators, and predictors of therapeutic change in cognitive-behavioral therapy for chronic pain. Pain. 2007;127(3):276–86.PubMedCrossRef
51.
Sandford FM, Sanders TAB, Lewis JS. Exploring experiences, barriers, and enablers to home- and class-based exercise in rotator cuff tendinopathy: A qualitative study. J Hand Ther. 2017;30(2):193–9.PubMedCrossRef
52.
Bandholm T, Christensen R, Thorborg K, Treweek S, Henriksen M. Preparing for what the reporting checklists will not tell you: the PREPARE Trial guide for planning clinical research to avoid research waste. Br J Sports Med. 2017;51(20):1494–501.PubMedCrossRef
53.
Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–7.PubMedPubMedCentralCrossRef
54.
55.
Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348:g1687.PubMedCrossRef
56.
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
57.
58.
59.
Jobe FW, Jobe CM. Painful athletic injuries of the shoulder. Clin Orthop Relat Res. 1983;173:117–24.CrossRef
60.
61.
Michener LA, Walsworth MK, Doukas WC, Murphy KP. Reliability and diagnostic accuracy of 5 physical examination tests and combination of tests for subacromial impingement. Arch Phys Med Rehabil. 2009;90(11):1898–903.PubMedCrossRef
62.
Kelly SM, Brittle N, Allen GM. The value of physical tests for subacromial impingement syndrome: a study of diagnostic accuracy. Clin Rehabil. 2010;24(2):149–58.PubMedCrossRef
63.
Martin-Hervas C, Romero J, Navas-Acien A, Reboiras JJ, Munuera L. Ultrasonographic and magnetic resonance images of rotator cuff lesions compared with arthroscopy or open surgery findings. J Shoulder Elbow Surg. 2001;10(5):410–5.PubMedCrossRef
64.
Naredo AE, Aguado P, Padron M, Bernad M, Uson J, Mayordomo L, et al. A comparative study of ultrasonography with magnetic resonance imaging in patients with painful shoulder. J Clin Rheumatol. 1999;5(4):184–92.PubMedCrossRef
65.
Ingwersen KG, Hjarbaek J, Eshoej H, Larsen CM, Vobbe J, Juul-Kristensen B. Ultrasound assessment for grading structural tendon changes in supraspinatus tendinopathy: an inter-rater reliability study. BMJ Open. 2016;6(5):e011746.PubMedPubMedCentralCrossRef
66.
Cools AM, Cambier D, Witvrouw EE. Screening the athlete’s shoulder for impingement symptoms: a clinical reasoning algorithm for early detection of shoulder pathology. Br J Sports Med. 2008;42(8):628–35.PubMedCrossRef
67.
O’Brien SJ, Pagnani MJ, Fealy S, McGlynn SR, Wilson JB. The active compression test: a new and effective test for diagnosing labral tears and acromioclavicular joint abnormality. Am J Sports Med. 1998;26(5):610–3.PubMedCrossRef
68.
Kosek E, Ekholm J, Nordemar R. A comparison of pressure pain thresholds in different tissues and body regions Long-term reliability of pressure algometry in healthy volunteers. Scand J Rehabil Med. 1993;25(3):117–24.PubMed
69.
Edwards PK, Ebert JR, Littlewood C, Ackland T, Wang A. A Systematic Review of Electromyography Studies in Normal Shoulders to Inform Postoperative Rehabilitation Following Rotator Cuff Repair. J Orthop Sports Phys Ther. 2017;47(12):931–44.PubMedCrossRef
70.
Cools AM, Tongel AV, Berckmans K, Spanhove V, Plaetevoet T, Rosseel J, et al. Electromyographic analysis of selected shoulder muscles during a series of exercises commonly used in patients with symptomatic degenerative rotator cuff tears. J Shoulder Elbow Surg. 2020;29(10):e361–73.PubMedCrossRef
71.
Sangwan S, Green RA, Taylor NF. Stabilizing characteristics of rotator cuff muscles: a systematic review. Disabil Rehabil. 2015;37(12):1033–43.PubMedCrossRef
72.
Desmeules F, Minville L, Riederer B, Cote CH, Fremont P. Acromio-humeral distance variation measured by ultrasonography and its association with the outcome of rehabilitation for shoulder impingement syndrome. Clin J Sport Med. 2004;14(4):197–205.PubMedCrossRef
73.
74.
Boettcher CE, Ginn KA, Cathers I. Which is the optimal exercise to strengthen supraspinatus? Med Sci Sports Exerc. 2009;41(11):1979–83.PubMedCrossRef
75.
Mintken PE, Glynn P, Cleland JA. Psychometric properties of the shortened disabilities of the arm, shoulder, and hand questionnaire (QuickDASH) and numeric pain rating scale in patients with shoulder pain. J Shoulder Elbow Surg. 2009;18(6):920–6.PubMedCrossRef
76.
77.
Dabija DI, Jain NB. Minimal clinically important difference of shoulder outcome measures and diagnoses: a systematic review. Am J Phys Med Rehabil. 2019;98(8):671–6.PubMedPubMedCentralCrossRef
78.
Dejaco B, Habets B, van Loon C, van Grinsven S, van Cingel R. Eccentric versus conventional exercise therapy in patients with rotator cuff tendinopathy: a randomized, single blinded, clinical trial. Knee Surg Sports Traumatol Arthrosc. 2017;25(7):2051–9.PubMedCrossRef
79.
Christiansen DH, Andersen JH, Haahr JP. Cross-cultural adaption and measurement properties of the Danish version of the Shoulder Pain and Disability Index. Clin Rehabil. 2013;27(4):355–60.PubMedCrossRef
80.
Roe Y, Soberg HL, Bautz-Holter E, Ostensjo S. A systematic review of measures of shoulder pain and functioning using the International classification of functioning, disability and health (ICF). BMC Musculoskelet Disord. 2013;14:73.PubMedPubMedCentralCrossRef
81.
Angst F, Schwyzer HK, Aeschlimann A, Simmen BR, Goldhahn J. Measures of adult shoulder function. Arthritis Care Res. 2011;63(Suppl 11):S174–88.
82.
Angst F, Goldhahn J, Drerup S, Aeschlimann A, Schwyzer HK, Simmen BR. Responsiveness of six outcome assessment instruments in total shoulder arthroplasty. Arthritis Rheum. 2008;59(3):391–8.PubMedCrossRef
83.
Beaton D, Richards RR. Assessing the reliability and responsiveness of 5 shoulder questionnaires. J shoulder Elbow Surg. 1998;7(6):565–72.PubMedCrossRef
84.
Paul A, Lewis M, Shadforth MF, Croft PR, Van Der Windt DA, Hay EM. A comparison of four shoulder-specific questionnaires in primary care. Ann Rheum Dis. 2004;63(10):1293–9.PubMedPubMedCentralCrossRef
85.
MacDermid JC, Drosdowech D, Faber K. Responsiveness of self-report scales in patients recovering from rotator cuff surgery. J Shoulder Elbow Surg. 2006;15(4):407–14.PubMedCrossRef
86.
Roy JS, MacDermid JC, Woodhouse LJ. Measuring shoulder function: a systematic review of four questionnaires. Arthritis Rheum. 2009;61(5):623–32.PubMedCrossRef
87.
Huang H, Grant JA, Miller BS, Mirza FM, Gagnier JJ. A Systematic Review of the Psychometric Properties of Patient-Reported Outcome Instruments for Use in Patients With Rotator Cuff Disease. Am J Sports Med. 2015;43(10):2572–82.PubMedCrossRef
88.
89.
Herup A, Merser S, Boeckstyns M. Validation of questionnaire for conditions of the upper extremity. Ugeskr Laeger. 2010;172(48):3333–6.PubMed
90.
Beaton DE, Wright JG, Katz JN. Development of the QuickDASH: comparison of three item-reduction approaches. J Bone Joint Surg Am. 2005;87(5):1038–46.PubMed
91.
Collaboration A, Abelev B, Adam J, Adamova D, Adare AM, Aggarwal MM, et al. Measurement of inelastic, single- and double-diffraction cross sections in proton-proton collisions at the LHC with ALICE. Eur Phys J C Part Fields. 2013;73(6):2456.ADS
92.
Tubach F, Dougados M, Falissard B, Baron G, Logeart I, Ravaud P. Feeling good rather than feeling better matters more to patients. Arthritis Rheum. 2006;55(4):526–30.PubMedCrossRef
93.
Tubach F, Pham T, Skomsvoll JF, Mikkelsen K, Bjorneboe O, Ravaud P, et al. Stability of the patient acceptable symptomatic state over time in outcome criteria in ankylosing spondylitis. Arthritis Rheum. 2006;55(6):960–3.PubMedCrossRef
94.
Tashjian RZ, Deloach J, Porucznik CA, Powell AP. Minimal clinically important differences (MCID) and patient acceptable symptomatic state (PASS) for visual analog scales (VAS) measuring pain in patients treated for rotator cuff disease. J Shoulder Elbow Surg. 2009;18(6):927–32.PubMedCrossRef
95.
96.
Christie A, Dagfinrud H, Garratt AM, Ringen Osnes H, Hagen KB. Identification of shoulder-specific patient acceptable symptom state in patients with rheumatic diseases undergoing shoulder surgery. J Hand Ther. 2011;24(1):53–60 (quiz 1).PubMedCrossRef
97.
Pham T, Tubach F. Patient acceptable symptomatic state (PASS). Joint Bone Spine. 2009;76(4):321–3.PubMedCrossRef
98.
Maksymowych WP, Richardson R, Mallon C, van der Heijde D, Boonen A. Evaluation and validation of the patient acceptable symptom state (PASS) in patients with ankylosing spondylitis. Arthritis Rheum. 2007;57(1):133–9.PubMedCrossRef
99.
Cook C, Learman K, Houghton S, Showalter C, O’Halloran B. The addition of cervical unilateral posterior-anterior mobilisation in the treatment of patients with shoulder impingement syndrome: a randomised clinical trial. Man Ther. 2014;19(1):18–24.PubMedCrossRef
100.
Mintken PE, McDevitt AW, Cleland JA, Boyles RE, Beardslee AR, Burns SA, et al. Cervicothoracic Manual Therapy Plus Exercise Therapy Versus Exercise Therapy Alone in the Management of Individuals With Shoulder Pain: A Multicenter Randomized Controlled Trial. J Orthop Sports Phys Ther. 2016;46(8):617–28.PubMedCrossRef
101.
de Vet HC, Terwee CB, Ostelo RW, Beckerman H, Knol DL, Bouter LM. Minimal changes in health status questionnaires: distinction between minimally detectable change and minimally important change. Health Qual Life Outcomes. 2006;4:54.PubMedPubMedCentralCrossRef
102.
Revicki D, Hays RD, Cella D, Sloan J. Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. J Clin Epidemiol. 2008;61(2):102–9.PubMedCrossRef
103.
Cools AM, De Wilde L, Van Tongel A, Ceyssens C, Ryckewaert R, Cambier DC. Measuring shoulder external and internal rotation strength and range of motion: comprehensive intra-rater and inter-rater reliability study of several testing protocols. J Shoulder Elbow Surg. 2014;23(10):1454–61.PubMedCrossRef
104.
de Winter AF, Heemskerk MA, Terwee CB, Jans MP, Deville W, van Schaardenburg DJ, et al. Inter-observer reproducibility of measurements of range of motion in patients with shoulder pain using a digital inclinometer. BMC Musculoskelet Disord. 2004;5:18.PubMedPubMedCentralCrossRef
105.
Cadogan A, Laslett M, Hing W, McNair P, Williams M. Reliability of a new hand-held dynamometer in measuring shoulder range of motion and strength. Man Ther. 2011;16(1):97–101.PubMedCrossRef
106.
Edouard P, Samozino P, Julia M, Gleizes Cervera S, Vanbiervliet W, Calmels P, et al. Reliability of isokinetic assessment of shoulder-rotator strength: a systematic review of the effect of position. J Sport Rehabil. 2011;20(3):367–83.PubMedCrossRef
107.
Reeves JL, Jaeger B, Graff-Radford SB. Reliability of the pressure algometer as a measure of myofascial trigger point sensitivity. Pain. 1986;24(3):313–21.PubMedCrossRef
108.
Persson AL, Brogardh C, Sjolund BH. Tender or not tender: test-retest repeatability of pressure pain thresholds in the trapezius and deltoid muscles of healthy women. J Rehabil Med. 2004;36(1):17–27.PubMedCrossRef
109.
Persson AL, Hansson GA, Kalliomaki J, Sjolund BH. Increases in local pressure pain thresholds after muscle exertion in women with chronic shoulder pain. Arch Phys Med Rehabil. 2003;84(10):1515–22.PubMedCrossRef
110.
Seitz AL, Michener LA. Ultrasonographic measures of subacromial space in patients with rotator cuff disease: A systematic review. J Clin Ultrasound. 2011;39(3):146–54.PubMedCrossRef
111.
Michener LA, Subasi Yesilyaprak SS, Seitz AL, Timmons MK, Walsworth MK. Supraspinatus tendon and subacromial space parameters measured on ultrasonographic imaging in subacromial impingement syndrome. Knee Surg Sports Traumato Arthrosc. 2015;23(2):363–9.CrossRef
112.
Sunding K, Fahlstrom M, Werner S, Forssblad M, Willberg L. Evaluation of Achilles and patellar tendinopathy with greyscale ultrasound and colour Doppler: using a four-grade scale. Knee Surg Sports Traumatol Arthrosc. 2016;24(6):1988–96.PubMedCrossRef
113.
Poltawski L, Ali S, Jayaram V, Watson T. Reliability of sonographic assessment of tendinopathy in tennis elbow. Skeletal Radiol. 2012;41(1):83–9.PubMedCrossRef
114.
Brooks J, McCluskey S, Turley E, King N. The Utility of Template Analysis in Qualitative Psychology Research. Qual Res Psychol. 2015;12(2):202–22.PubMedCrossRef
115.
Baldwin T, Ford J. Transfer of Training: A Review and Directions for Future Research. Pers Psychol. 1988;41:63–105.CrossRef
116.
Grossman R, Salas E. The transfer of training: what really matters. Int J Dev. 2011;15(2):103–20.
117.
Dufouil C, Brayne C, Clayton D. Analysis of longitudinal studies with death and drop-out: a case study. Stat Med. 2004;23(14):2215–26.PubMedCrossRef
118.
Pavlova AV, Shim JSC, Moss R, Maclean C, Brandie D, Mitchell L, et al. Effect of resistance exercise dose components for tendinopathy management: a systematic review with meta-analysis. Br J Sports Med. 2023;57(20):1327–34.PubMedCrossRef
119.
Lewis J. Rotator cuff related shoulder pain: Assessment, management and uncertainties. Man Ther. 2016;23:57–68.ADSPubMedCrossRef
120.
Cavaggion C, Juul-Kristensen B, Luque Suarez A, Voogt L, Wollants G, O Conaire E, et al. Exercise into pain in chronic rotator cuff related shoulder pain a prospective single-group feasibility study. BMJ open. 2023;13(10):070698.CrossRef
Metadata
Title
To allow or avoid pain during shoulder rehabilitation exercises for patients with chronic rotator cuff tendinopathy-Study protocol for a randomized controlled trial (the PASE trial)
Authors
Birgitte Hougs Kjær
Ann M. Cools
Finn E. Johannsen
Jeanette Trøstrup
Theresa Bieler
Volkert Siersma
Peter S. Magnusson
Publication date
01-12-2024
Publisher
BioMed Central
Keyword
Tendinopathy
Published in
Trials / Issue 1/2024
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-024-07973-6

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