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 1/2015

Open Access 01-12-2015 | Study protocol

Progressive high-load strength training compared with general low-load exercises in patients with rotator cuff tendinopathy: study protocol for a randomised controlled trial

Authors: Kim G Ingwersen, Robin Christensen, Lilli Sørensen, Hans RI Jørgensen, Steen Lund Jensen, Sten Rasmussen, Karen Søgaard, Birgit Juul-Kristensen

Published in: Trials | Issue 1/2015

Login to get access

Abstract

Background

Shoulder pain is the third most common musculoskeletal disorder, often affecting people’s daily living and work capacity. The most common shoulder disorder is the subacromial impingement syndrome (SIS) which, among other pathophysiological changes, is often characterised by rotator cuff tendinopathy. Exercise is often considered the primary treatment option for rotator cuff tendinopathy, but there is no consensus on which exercise strategy is the most effective. As eccentric and high-load strength training have been shown to have a positive effect on patella and Achilles tendinopathy, the aim of this trial is to compare the efficacy of progressive high-load exercises with traditional low-load exercises in patients with rotator cuff tendinopathy.

Methods/Design

The current study is a randomised, participant- and assessor-blinded, controlled multicentre trial. A total of 260 patients with rotator cuff tendinopathy will be recruited from three outpatient shoulder departments in Denmark, and randomised to either 12 weeks of progressive high-load strength training or to general low-load exercises. Patients will receive six individually guided exercise sessions with a physiotherapist and perform home-based exercises three times a week. The primary outcome measure will be change from baseline to 12 weeks in the patient-reported outcome Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire.

Discussion

Previous studies of exercise treatment for SIS have not differentiated between subgroups of SIS and have often had methodological flaws, making it difficult to specifically design target treatment for patients diagnosed with SIS. Therefore, it was considered important to focus on a subgroup such as tendinopathy, with a specific tailored intervention strategy based on evidence from other regions of the body, and to clearly describe the intervention in a methodologically strong study.

Trial registration

The trial was registered with Clinicaltrials.gov (NCT01984203) on 31 October 2013.
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;33:73–81.CrossRefPubMed
2.
Miranda H, Viikari-Juntura E, Heistaro S, Heliovaara M, Riihimaki H. A population study on differences in the determinants of a specific shoulder disorder versus nonspecific shoulder pain without clinical findings. Am J Epidemiol. 2005;161:847–55.CrossRefPubMed
3.
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;24:253–9.CrossRefPubMed
4.
Feleus A, Bierma-Zeinstra SM, Miedema HS, Verhaar JA, Koes BW. Management in non-traumatic arm, neck and shoulder complaints: differences between diagnostic groups. Eur Spine J. 2008;17:1218–29.CrossRefPubMedPubMedCentral
5.
van der Windt DA, Koes BW, de Jong BA, Bouter LM. Shoulder disorders in general practice: incidence, patient characteristics, and management. Ann Rheum Dis. 1995;54:959–64.CrossRefPubMedPubMedCentral
6.
Huisstede BM, Miedema HS, Verhagen AP, Koes BW, Verhaar JA. Multidisciplinary consensus on the terminology and classification of complaints of the arm, neck and/or shoulder. Occup Environ Med. 2007;64:313–9.CrossRefPubMed
7.
Lewis JS. Rotator cuff tendinopathy/subacromial impingement syndrome: is it time for a new method of assessment? Br J Sports Med. 2009;43:259–64.CrossRefPubMed
8.
Littlewood C, Ashton J, Chance-Larsen K, May S, Sturrock B. Exercise for rotator cuff tendinopathy: a systematic review. Physiotherapy. 2012;98:101–9.CrossRefPubMed
9.
10.
Brox JI, Gjengedal E, Uppheim G, Bohmer AS, Brevik JI, Ljunggren AE, et al. Arthroscopic surgery versus supervised exercises in patients with rotator cuff disease (stage II impingement syndrome): a prospective, randomized, controlled study in 125 patients with a 2 1/2-year follow-up. J Shoulder Elbow Surg. 1999;8:102–11.CrossRefPubMed
11.
Brox JI, Staff PH, Ljunggren AE, Brevik JI. Arthroscopic surgery compared with supervised exercises in patients with rotator cuff disease (stage II impingement syndrome). BMJ. 1993;307:899–903.CrossRefPubMedPubMedCentral
12.
Haahr JP, Andersen JH. Exercises may be as efficient as subacromial decompression in patients with subacromial stage II impingement: 4-8-years’ follow-up in a prospective, randomized study. Scand J Rheumatol. 2006;35:224–8.CrossRefPubMed
13.
Haahr JP, Ostergaard S, Dalsgaard J, Norup K, Frost P, Lausen S, et al. Exercises versus arthroscopic decompression in patients with subacromial impingement: a randomised, controlled study in 90 cases with a one year follow up. Ann Rheum Dis. 2005;64:760–4.CrossRefPubMedPubMedCentral
14.
Ketola S, Lehtinen J, Arnala I, Nissinen M, Westenius H, Sintonen H, et al. Does arthroscopic acromioplasty provide any additional value in the treatment of shoulder impingement syndrome?: a two-year randomised controlled trial. J Bone Joint Surg Br. 2009;91:1326–34.CrossRefPubMed
15.
Malliaras P, Barton CJ, Reeves ND, Langberg H. Achilles and patellar tendinopathy loading programmes: a systematic review comparing clinical outcomes and identifying potential mechanisms for effectiveness. Sports Med. 2013;43:267–86.CrossRefPubMed
16.
17.
Cook JL, Purdam CR. Is tendon pathology a continuum? A pathology model to explain the clinical presentation of load-induced tendinopathy. Br J Sports Med. 2009;43:409–16.CrossRefPubMed
18.
Kingma JJ, de Knikker R, Wittink HM, Takken T. Eccentric overload training in patients with chronic Achilles tendinopathy: a systematic review. Br J Sports Med. 2007;41:e3.CrossRefPubMed
19.
Ohberg L, Alfredson H. Effects on neovascularisation behind the good results with eccentric training in chronic mid-portion Achilles tendinosis? Knee Surg Sports Traumatol Arthrosc. 2004;12:465–70.CrossRefPubMed
20.
Ohberg L, Lorentzon R, Alfredson H. Eccentric training in patients with chronic Achilles tendinosis: normalised tendon structure and decreased thickness at follow up. Br J Sports Med. 2004;38:8–11. discussion 11.CrossRefPubMedPubMedCentral
21.
Langberg H, Ellingsgaard H, Madsen T, Jansson J, Magnusson SP, Aagaard P, et al. Eccentric rehabilitation exercise increases peritendinous type I collagen synthesis in humans with Achilles tendinosis. Scand J Med Sci Sports. 2007;17:61–6.PubMed
22.
Miller BF, Olesen JL, Hansen M, Dossing S, Crameri RM, Welling RJ, et al. Coordinated collagen and muscle protein synthesis in human patella tendon and quadriceps muscle after exercise. J Physiol. 2005;567:1021–33.CrossRefPubMedPubMedCentral
23.
Langberg H, Kongsgaard M. Eccentric training in tendinopathy–more questions than answers. Scand J Med Sci Sports. 2008;18:541–2.CrossRefPubMed
24.
Frohm A, Saartok T, Halvorsen K, Renstrom P. Eccentric treatment for patellar tendinopathy: a prospective randomised short-term pilot study of two rehabilitation protocols. Br J Sports Med. 2007;41:e7.CrossRefPubMed
25.
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;19:790–802.CrossRefPubMed
26.
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;38:749–56.CrossRefPubMed
27.
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;21:1158–67.CrossRefPubMed
28.
Lombardi Jr I, 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;59:615–22.CrossRefPubMed
29.
Jonsson P, Wahlstrom P, Ohberg L, Alfredson H. Eccentric training in chronic painful impingement syndrome of the shoulder: results of a pilot study. Knee Surg Sports Traumatol Arthrosc. 2006;14:76–81.CrossRefPubMed
30.
Holmgren T, Bjornsson Hallgren H, Oberg B, Adolfsson L, Johansson K. Effect of specific exercise strategy on need for surgery in patients with subacromial impingement syndrome: randomised controlled study. BMJ. 2012;344:e787.CrossRefPubMedPubMedCentral
31.
Camargo PR, Avila MA, Alburquerque-Sendin F, Asso NA, Hashimoto LH, Salvini TF. Eccentric training for shoulder abductors improves pain, function and isokinetic performance in subjects with shoulder impingement syndrome: a case series. Rev Bras Fisioter. 2012;16:74–83.CrossRefPubMed
32.
Bernhardsson S, Klintberg IH, Wendt GK. Evaluation of an exercise concept focusing on eccentric strength training of the rotator cuff for patients with subacromial impingement syndrome. Clin Rehabil. 2011;25:69–78.CrossRefPubMed
33.
Poltawski L, Ali S, Jayaram V, Watson T. Reliability of sonographic assessment of tendinopathy in tennis elbow. Skeletal Radiol. 2012;41:83–9.CrossRefPubMed
34.
Kim SY, Ko JB, Farthing JP, Butcher SJ: Investigation of supraspinatus muscle architecture following concentric and eccentric training. J Sci Med Sport. 2014. doi: 10.1016/j.jsams.2014.05.007.
35.
Kim S, Bleakney R, Boynton E, Ravichandiran K, Rindlisbacher T, McKee N, et al. Investigation of the static and dynamic musculotendinous architecture of supraspinatus. Clin Anat. 2010;23:48–55.CrossRefPubMed
36.
Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med. 1996;29:602–8.CrossRefPubMed
37.
Ingwersen KG BJ-K. Shoulder Injury and Osteoarthritis Outcome Score (SOOS) - Reliability and Validity of a New Patient Reported Outcome Measure. In: Sports Medicine Congress; 2012 Feb 2–4; Kolding, Denmark. Kolding, Denmark: Dansk Idrætsmedicinsk Selskab; 2012.
38.
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67:361–70.CrossRefPubMed
39.
Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001;33:337–43.CrossRefPubMed
40.
Carlsson AM. Assessment of chronic pain. I. Aspects of the reliability and validity of the visual analogue scale. Pain. 1983;16:87–101.CrossRefPubMed
41.
Kibler WB. The role of the scapula in athletic shoulder function. Am J Sports Med. 1998;26:325–37.PubMed
42.
Kibler WB, McMullen J. Scapular dyskinesis and its relation to shoulder pain. J Am Acad Orthop Surg. 2003;11:142–51.CrossRefPubMed
43.
de Witte PB, Henseler JF, Nagels J, Vliet Vlieland TP, Nelissen RG. The Western Ontario rotator cuff index in rotator cuff disease patients: a comprehensive reliability and responsiveness validation study. Am J Sports Med. 2012;40:1611–9.CrossRefPubMed
44.
Karthikeyan S, Kwong HT, Upadhyay PK, Parsons N, Drew SJ, Griffin D. A double-blind randomised controlled study comparing subacromial injection of tenoxicam or methylprednisolone in patients with subacromial impingement. J Bone Joint Surg Br. 2010;92:77–82.CrossRefPubMed
45.
Lee JH, Lee SH, Song SH. Clinical effectiveness of botulinum toxin type B in the treatment of subacromial bursitis or shoulder impingement syndrome. Clin J Pain. 2011;27:523–8.CrossRefPubMed
46.
Michener LA, Snyder Valier AR, McClure PW. Defining substantial clinical benefit for patient-rated outcome tools for shoulder impingement syndrome. Arch Phys Med Rehabil. 2013;94:725–30.CrossRefPubMed
47.
Tate AR, McClure PW, Young IA, Salvatori R, Michener LA. Comprehensive impairment-based exercise and manual therapy intervention for patients with subacromial impingement syndrome: a case series. J Orthop Sports Phys Ther. 2010;40:474–93.CrossRefPubMed
48.
Christensen R, Bliddal H, Henriksen M. Enhancing the reporting and transparency of rheumatology research: a guide to reporting guidelines. Arthritis Res Ther. 2013;15:109.CrossRefPubMedPubMedCentral
49.
Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol. 2010;63:e1–37.CrossRefPubMed
50.
51.
Faber E, Kuiper JI, Burdorf A, Miedema HS, Verhaar JA. Treatment of impingement syndrome: a systematic review of the effects on functional limitations and return to work. J Occup Rehabil. 2006;16:7–25.CrossRefPubMed
52.
Kelly SM, Wrightson PA, Meads CA. Clinical outcomes of exercise in the management of subacromial impingement syndrome: a systematic review. Clin Rehabil. 2010;24:99–109.CrossRefPubMed
53.
Kromer TO, Tautenhahn UG, de Bie RA, Staal JB, Bastiaenen CH. Effects of physiotherapy in patients with shoulder impingement syndrome: a systematic review of the literature. J Rehabil Med. 2009;41:870–80.CrossRefPubMed
54.
Kuhn JE. Exercise in the treatment of rotator cuff impingement: a systematic review and a synthesized evidence-based rehabilitation protocol. J Shoulder Elbow Surg. 2009;18:138–60.CrossRefPubMed
55.
Michener LA, Walsworth MK, Burnet EN. Effectiveness of rehabilitation for patients with subacromial impingement syndrome: a systematic review. J Hand Ther. 2004;17:152–64.CrossRefPubMed
56.
Papadonikolakis A, McKenna M, Warme W, Martin BI, Matsen 3rd FA. Published evidence relevant to the diagnosis of impingement syndrome of the shoulder. J Bone Joint Surg Am. 2011;93:1827–32.CrossRefPubMed
57.
von der Heyde RL. Occupational therapy interventions for shoulder conditions: a systematic review. Am J Occup Ther. 2011;65:16–23.CrossRefPubMed
58.
Andersen CH, Zebis MK, Saervoll C, Sundstrup E, Jakobsen MD, Sjogaard G, et al. Scapular muscle activity from selected strengthening exercises performed at low and high intensities. J Strength Cond Res. 2012;26:2408–16.CrossRefPubMed
59.
Cools AM, Dewitte V, Lanszweert F, Notebaert D, Roets A, Soetens B, et al. Rehabilitation of scapular muscle balance: which exercises to prescribe? Am J Sports Med. 2007;35:1744–51.CrossRefPubMed
60.
Escamilla RF, Yamashiro K, Paulos L, Andrews JR. Shoulder muscle activity and function in common shoulder rehabilitation exercises. Sports Med. 2009;39:663–85.CrossRefPubMed
61.
Kibler WB, Sciascia AD, Uhl TL, Tambay N, Cunningham T. Electromyographic analysis of specific exercises for scapular control in early phases of shoulder rehabilitation. Am J Sports Med. 2008;36:1789–98.CrossRefPubMed
62.
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;10:410–5.CrossRefPubMed
Metadata
Title
Progressive high-load strength training compared with general low-load exercises in patients with rotator cuff tendinopathy: study protocol for a randomised controlled trial
Authors
Kim G Ingwersen
Robin Christensen
Lilli Sørensen
Hans RI Jørgensen
Steen Lund Jensen
Sten Rasmussen
Karen Søgaard
Birgit Juul-Kristensen
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-014-0544-6

Other articles of this Issue 1/2015

Trials 1/2015 Go to the issue

Study protocol

Persistent Occiput Posterior position - OUTcomes following manual rotation (POP-OUT): study protocol for a randomised controlled trial

Methodology

Lessons learned from recruiting socioeconomically disadvantaged smokers into a pilot randomized controlled trial to explore the role of Exercise Assisted Reduction then Stop (EARS) smoking

Study protocol

Development of an internationally agreed minimal dataset for juvenile dermatomyositis (JDM) for clinical and research use

Review

Interventions in randomised controlled trials in surgery: issues to consider during trial design

Study protocol

Reduced patient restrictions following total hip arthroplasty: study protocol for a randomized controlled trial

Study protocol

Sustained Aeration of Infant Lungs (SAIL) trial: study protocol for a randomized controlled trial