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 STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2019

Open Access 01-12-2019 | Study protocol

Reducing shoulder complaints in employees with high occupational shoulder exposures: study protocol for a cluster-randomised controlled study (The Shoulder-Café Study)

Authors: Jeanette Trøstrup, Lone Ramer Mikkelsen, Poul Frost, Annett Dalbøge, Mette Terp Høybye, Sven Dalgas Casper, Lene Bastrup Jørgensen, Thomas Martin Klebe, Susanne Wulff Svendsen

Published in: Trials | Issue 1/2019

Login to get access

Abstract

Background

In Denmark, exercise therapy in combination with work modification is the first-choice treatment for persons with shoulder complaints and high occupational shoulder exposures. To obtain this treatment they must visit several healthcare providers, which makes usual care fragmented and uncoordinated. Therefore, we developed a new intervention which unifies the expertise that is needed. The main hypotheses are that a group-based Shoulder-Café intervention will more effectively reduce (1) shoulder complaints and (2) occupational shoulder exposures than an individual-based Shoulder-Guidance intervention (active control – enhanced usual care).

Methods

A cluster-randomised trial is conducted including 120 employees with high occupational shoulder exposures. Companies (clusters) are randomised to either Shoulder-Café or Shoulder-Guidance with a 1:1 allocation ratio. Participants are 18–65 years old and have an Oxford Shoulder Score (OSS) ≤ 40. Both interventions include a home-based shoulder-exercise programme, assessment of shoulder exposures by technical measurements and self-report, and general information on how to reduce shoulder exposures. The Shoulder-Café course also includes three café meetings with physiotherapist-supervised exercises, clinical shoulder evaluation, education on shoulder anatomy, workplace-orientated counselling, and an opportunity for a workplace visit by a health and safety consultant. The primary outcomes are the OSS at 6-month follow-up (hypothesis I), and the mean number of min/day with the arm elevated > 60° shortly after the end of the intervention (hypothesis II). We will use a mixed-model analysis that allows for company clustering, and data will be analysed according to the intention-to-treat principle.

Discussion

Persons with shoulder complaints and high occupational shoulder exposures are an obvious target group for secondary prevention efforts. We developed the Shoulder-Café to reduce shoulder complaints and shoulder exposures while unifying the expertise that is needed to evaluate and treat shoulder complaints. If the intervention is effective, it would warrant widespread implementation.

Trial registration

Clinicaltrials.gov, ID: NCT03159910. Registered on 18 May 2017
Appendix
Available only for authorised users
Literature
1.
2.
Virta L, Joranger P, Brox JI, Eriksson R. Costs of shoulder pain and resource use in primary health care: a cost-of-illness study in Sweden. BMC Musculoskelet Disord. 2012;13:17 2474-13-17.CrossRefPubMedPubMedCentral
3.
Roquelaure Y, Ha C, Leclerc A, Touranchet A, Sauteron M, Melchior M, et al. Epidemiologic surveillance of upper-extremity musculoskeletal disorders in the working population. Arthritis Rheum. 2006;55:765–78.CrossRefPubMed
4.
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
5.
van der Molen HF, Foresti C, Daams JG, Frings-Dresen MHW, Kuijer PPFM. Work-related risk factors for specific shoulder disorders: a systematic review and meta-analysis. Occup Environ Med. 2017;74:745–55.CrossRefPubMed
6.
7.
Miranda H, Viikari-Juntura E, Martikainen R, Takala EP, Riihimaki H. A prospective study of work related factors and physical exercise as predictors of shoulder pain. Occup Environ Med. 2001;58:528–34.CrossRefPubMedPubMedCentral
8.
Pope DP, Silman AJ, Cherry NM, Pritchard C, Macfarlane GJ. Association of occupational physical demands and psychosocial working environment with disabling shoulder pain. Ann Rheum Dis. 2001;60:852–8.PubMedPubMedCentral
9.
Svendsen SW, Frost P. Arbejdsrelaterede skulderlidelser. [Work related shoulder disorders.]. Månedsskr Prakt Lægegern. 2004;6:757–67.
10.
Svendsen SW, Bonde JP, Mathiassen SE, Stengaard-Pedersen K, Frich LH. Work related shoulder disorders: quantitative exposure-response relations with reference to arm posture. Occup Environ Med. 2004;61:844–53.CrossRefPubMedPubMedCentral
11.
Dalbøge A, Frost P, Andersen JH, Svendsen SW. Cumulative occupational shoulder exposures and surgery for subacromial impingement syndrome: a nationwide Danish cohort study. Occup Environ Med. 2014;71:750–6.CrossRefPubMed
12.
Dalbøge A, Frost P, Andersen JH, Svendsen SW. Surgery for subacromial impingement syndrome in relation to occupational exposures, lifestyle factors and diabetes mellitus: a nationwide nested case-control study. Occup Environ Med. 2017;74:728–36.CrossRefPubMed
13.
Dalbøge A, Frost P, Andersen JH, Svendsen SW. Surgery for subacromial impingement syndrome in relation to intensities of occupational mechanical exposures across 10-year exposure time windows. Occup Environ Med. 2018;75:176–82.CrossRefPubMed
14.
Svendsen SW, Dalbøge A, Andersen JH, Thomsen JF, Frost P. Risk of surgery for subacromial impingement syndrome in relation to neck-shoulder complaints and occupational biomechanical exposures: a longitudinal study. Scand J Work Environ Health. 2013;39:568–77.CrossRefPubMed
15.
Sundhedsstyrelsen. National klinisk retningslinje for diagnostik og behandling af patienter med udvalgte skulderlidelser. [National clinical guidelines for diagnostic and treatment of patients with selected shoulder impairments.]. Copenhagen: Sundhedsstyrelsen [Danish Health Authority]; 2013.
16.
Sundhedsstyrelsen, Sygehusbehandling og Beredskab. Impingementsyndrom/rotator cuff-syndrom og traumatisk rotator cuff-ruptur. Del 2: Faglige Visitationsretningslinjer. [Hospital treatment and preparedness. Impingement syndrome/rotator cuff syndrome and traumatic rotator cuff rupture. Part 2: Professional Visiting Guidelines]. Copenhagen: Sundhedsstyrelsen [Danish Health Authority]; 2011.
17.
Løvschall C, Witt F, Svendsen SW, Hartvigsen J, Johannsen HV, Beck SS, et al. Medicinsk teknologivurdering af kirurgisk behandling af patienter med udvalgte og hyppige skulderlidelser. [Medical technology assessment of surgical treatment of patients with selected and frequent shoulder disorders.]. Aarhus: MTV og Sundhedstjeneste forskning, Region Midtjylland [MTV and Health Service Research, Central Denmark Region]; 2011.
18.
19.
Christensen FB, Laurberg I. Importance of the back-cafe concept to rehabilitation after lumbar spinal fusion: a randomized clinical study with a 2-year follow-up. Spine (Phila Pa 1976). 2003;28:2561–9.CrossRef
20.
Turk DC, Wilson HD. Fear of pain as a prognostic factor in chronic pain: conceptual models, assessment, and treatment implications. Curr Pain Headache Rep. 2010;14:88–95.CrossRefPubMedPubMedCentral
21.
Severeijns R, Vlaeyen JW, van den Hout MA, Picavet HS. Pain catastrophizing and consequences of musculoskeletal pain: a prospective study in the Dutch community. J Pain. 2005;6:125–32.CrossRefPubMed
22.
George SZ, Stryker SE. Fear-avoidance beliefs and clinical outcomes for patients seeking outpatient physical therapy for musculoskeletal pain conditions. J Orthop Sports Phys Ther. 2011;41:249–59.CrossRefPubMed
23.
Waddell G, Newton M, Henderson I, Somerville D, Main CJ. A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 1993;52:157–68.CrossRefPubMed
24.
Mintken PE, Cleland JA, Whitman JM, George SZ. Psychometric properties of the Fear-Avoidance Beliefs Questionnaire and Tampa Scale of Kinesiophobia in patients with shoulder pain. Arch Phys Med Rehabil. 2010;91:1128–36.CrossRefPubMed
25.
Christiansen DH, Frost P, Falla D, Haahr JP, Frich LH, Andrea LC, et al. Effectiveness of standardized physical therapy exercises for patients with difficulty returning to usual activities after decompression surgery for subacromial impingement syndrome: randomized controlled trial. Phys Ther. 2016;96:787–96.CrossRefPubMed
26.
Hurst H, Bolton J. Assessing the clinical significance of change scores recorded on subjective outcome measures. J Manip Physiol Ther. 2004;27:26–35.CrossRef
27.
Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;158:200–7.
28.
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.CrossRefPubMed
29.
Dalbøge A, Hansson GA, Frost P, Andersen JH, Heilskov-Hansen T, Svendsen SW. Upper arm elevation and repetitive shoulder movements: a general population job exposure matrix based on expert ratings and technical measurements. Occup Environ Med. 2016;73:553–60.CrossRefPubMed
30.
Dawson J, Fitzpatrick R, Carr A. Questionnaire on the perceptions of patients about shoulder surgery. J Bone Joint Surg Br. 1996;78:593–600.CrossRefPubMed
31.
Dawson J, Rogers K, Fitzpatrick R, Carr A. The Oxford Shoulder Score revisited. Arch Orthop Trauma Surg. 2009;129:119–23.CrossRefPubMed
32.
Frich LH, Noergaard PM, Brorson S. Validation of the Danish version of Oxford Shoulder Score. Dan Med Bull. 2011;58:A4335.PubMed
33.
McLean JM, Awwad D, Lisle R, Besanko J, Shivakkumar D, Leith J. An international, multicenter cohort study comparing 6 shoulder clinical scores in an asymptomatic population. J Shoulder Elb Surg. 2018;27:306–14.CrossRef
34.
Younis F, Sultan J, Dix S, Hughes PJ. The range of the Oxford Shoulder Score in the asymptomatic population: a marker for post-operative improvement. Ann R Coll Surg Engl. 2011;93:629–33.CrossRefPubMedPubMedCentral
35.
Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M, et al. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:a1655.CrossRefPubMedPubMedCentral
36.
Littlewood C, Bateman M, Brown K, Bury J, Mawson S, May S, et al. A self-managed single exercise programme versus usual physiotherapy treatment for rotator cuff tendinopathy: a randomised controlled trial (the SELF study). Clin Rehabil. 2016;30:686–96.CrossRefPubMed
37.
Ingwersen KG, Jensen SL, Sørensen L, Jørgensen HR, Christensen R, Søgaard 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;5:2325967117723292.CrossRefPubMedPubMedCentral
38.
Holmgren T, Hallgren H, Öberg 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
39.
Page MJ, Green S, McBain B, Surace SJ, Deitch J, Lyttle N, et al. Manual therapy and exercise for rotator cuff disease. Cochrane Database Syst Rev. 2016;6:CD012224.
40.
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
41.
Hanratty CE, McVeigh JG, Kerr DP, Basford JR, Finch MB, Pendleton A, et al. The effectiveness of physiotherapy exercises in subacromial impingement syndrome: a systematic review and meta-analysis. Semin Arthritis Rheum. 2012;42:297–316.CrossRefPubMed
42.
Klintberg IH, Cools AM, Holmgren TM, Holzhausen AC, Johansson K, Maenhout AG, et al. Consensus for physiotherapy for shoulder pain. Int Orthop. 2015;39:715–20.CrossRefPubMed
43.
Desmeules F, Boudreault J, Dionne CE, Fremont P, Lowry V, MacDermid JC, et al. Efficacy of exercise therapy in workers with rotator cuff tendinopathy: a systematic review. J Occup Health. 2016;58:389–403.CrossRefPubMedPubMedCentral
44.
Peterson MD, Rhea MR, Alvar BA. Applications of the dose-response for muscular strength development: a review of meta-analytic efficacy and reliability for designing training prescription. J Strength Cond Res. 2005;19:950–8.PubMed
45.
Babatunde FO, MacDermid JC, MacIntyre N. A therapist-focused knowledge translation intervention for improving patient adherence in musculoskeletal physiotherapy practice. Arch Physiother. 2017;7:1.CrossRefPubMedPubMedCentral
46.
47.
Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14:377–81.PubMed
48.
Brox JI. Regional musculoskeletal conditions: shoulder pain. Best Pract Res Clin Rheumatol. 2003;17:33–56.CrossRefPubMed
49.
Rosdahl G. Den Motiverende samtale i teori og praksis. [The motivational conversation in theory and practice.] 1. udgave, 2. oplag, ed. (1st edition, 2nd printing, ed.). Copenhagen: Munksgaard; 2013.
50.
Glanz K, Rimer BK, Lewis FM, editors. Health behavior and health education: theory, research, and practice. 3rd ed. San Francisco: Jossey-Bass; 2002.
51.
Savinainen M, Oksa P. Efficiency of workplace surveys conducted by Finnish occupational health services. AAOHN J. 2011;59:303–10.CrossRefPubMed
52.
53.
Dawson J, Harris KK, Doll H, Fitzpatrick R, Carr A. A comparison of the Oxford Shoulder Score and Shoulder Pain and Disability Index: factor structure in the context of a large randomized controlled trial. Patient Relat Outcome Meas. 2016;7:195–203.CrossRefPubMedPubMedCentral
54.
Dawson J, Hill G, Fitzpatrick R, Carr A. Comparison of clinical and patient-based measures to assess medium-term outcomes following shoulder surgery for disorders of the rotator cuff. Arthritis Rheum. 2002;47:513–9.CrossRefPubMed
55.
Ekeberg OM, Bautz-Holter E, Keller A, Tveita EK, Juel NG, Brox JI. A questionnaire found disease-specific WORC index is not more responsive than SPADI and OSS in rotator cuff disease. J Clin Epidemiol. 2010;63:575–84.CrossRefPubMed
56.
Ekeberg OM, Bautz-Holter E, Tveita EK, Keller A, Juel NG, Brox JI. Agreement, reliability and validity in 3 shoulder questionnaires in patients with rotator cuff disease. BMC Musculoskelet Disord. 2008;9:68 2474-9-68.CrossRefPubMedPubMedCentral
57.
Schmidt S, Ferrer M, Gonzalez M, Gonzalez N, Valderas JM, Alonso J, et al. Evaluation of shoulder-specific patient-reported outcome measures: a systematic and standardized comparison of available evidence. J Shoulder Elb Surg. 2014;23:434–44.CrossRef
58.
Herup A, Merser S, Boeckstyns M. Validation of questionnaire for conditions of the upper extremity. Ugeskr Laeger. 2010;172:3333–6.PubMed
59.
EuroQol Group. EuroQol—a new facility for the measurement of health-related quality of life. Health Policy. 1990;16:199–208.CrossRef
60.
Ahlstrom L, Grimby-Ekman A, Hagberg M, Dellve L. The Work Ability Index and single-item question: associations with sick leave, symptoms, and health—a prospective study of women on long-term sick leave. Scand J Work Environ Health. 2010;36:404–12.CrossRefPubMed
61.
Gould R, Ilmarinen J, Järvisalo J, Koskinen S. Dimensions of work ability. Results for the Health 2000 Survey. Helsinki: Finnish Centre for Pensions; 2008.
62.
Karasek R, Theorell T. Healthy work: stress, productivity, and the reconstruction of working life. New York: Basic Books; 1990.
63.
Rathleff MS, Bandholm T, Ahrendt P, Olesen JL, Thorborg K. Novel stretch-sensor technology allows quantification of adherence and quality of home-exercises: a validation study. Br J Sports Med. 2014;48:724–8.CrossRefPubMed
64.
Rathleff MS, Thorborg K, Rode LA, McGirr KA, Sørensen AS, Bøgild A, et al. Adherence to commonly prescribed, home-based strength training exercises for the lower extremity can be objectively monitored using the Bandcizer. J Strength Cond Res. 2015;29:627–36.CrossRefPubMed
65.
McGirr K, Harring SI, Kennedy TS, Pedersen MF, Hirata RP, Thorborg K, et al. An elastic exercise band mounted with a Bandcizer can differentiate between commonly prescribed home exercises for the shoulder. Int J Sports Phys Ther. 2015;10:332–40.PubMedPubMedCentral
66.
67.
Christiansen DH, Frost P, Falla D, Haahr JP, Frich LH, Svendsen SW. Responsiveness and minimal clinically important change: a comparison between 2 shoulder outcome measures. J Orthop Sports Phys Ther. 2015;45:620–5.CrossRefPubMed
68.
Beard D, Rees J, Rombach I, Cooper C, Cook J, Merritt N, et al. The CSAW Study (Can Shoulder Arthroscopy Work?)—a placebo-controlled surgical intervention trial assessing the clinical and cost effectiveness of arthroscopic subacromial decompression for shoulder pain: study protocol for a randomised controlled trial. Trials. 2015;16:210 015–0725-y.CrossRefPubMedPubMedCentral
69.
Campbell MK, Piaggio G, Elbourne DR, Altman DG, CONSORT Group. CONSORT 2010 Statement: extension to cluster randomised trials. BMJ. 2012;345:e5661.CrossRefPubMed
70.
Adams G, Gulliford MC, Ukoumunne OC, Eldridge S, Chinn S, Campbell MJ. Patterns of intra-cluster correlation from primary care research to inform study design and analysis. J Clin Epidemiol. 2004;57:785–94.CrossRefPubMed
71.
Saunders RP, Evans MH, Joshi P. Developing a process-evaluation plan for assessing health promotion program implementation: a how-to guide. Health Promot Pract. 2005;6:134–47.CrossRefPubMed
72.
Green J, Tones K, Cross R, Woodall J. Health promotion—planning & strategies. 3rd ed. London: Sage; 2015.
73.
Christensen U, Schmidt L, Dyhr L. editor. Det kvalitative forskningsinterview. [The qualitative research interview]. In: Vallgårda S, Koch L (eds.) Forskningsmetoder i folkesundhedsvidenskab [Research methods in public health]. Copenhagen: Munksgaard; 2008.
74.
Tjørnhøj-Thomsen T, Whyte S. Fieldwork and participant observation. In: Vallgårda S, Koch L, editors. Research Methods in Public Health. Copenhagen: Munksgaard; 2008.
75.
Heron SR, Woby SR, Thompson DP. Comparison of three types of exercise in the treatment of rotator cuff tendinopathy/shoulder impingement syndrome: a randomized controlled trial. Physiotherapy. 2017;103:167–73.CrossRefPubMed
76.
Kuhn JE. Exercise in the treatment of rotator cuff impingement: a systematic review and a synthesized evidence-based rehabilitation protocol. J Shoulder Elb Surg. 2009;18:138–60.CrossRef
77.
Hoe VC, Urquhart DM, Kelsall HL, Sim MR. Ergonomic design and training for preventing work-related musculoskeletal disorders of the upper limb and neck in adults. Cochrane Database Syst Rev. 2012;8:CD008570.
78.
Van Eerd D, Munhall C, Irvin E, Rempel D, Brewer S, van der Beek AJ, et al. Effectiveness of workplace interventions in the prevention of upper extremity musculoskeletal disorders and symptoms: an update of the evidence. Occup Environ Med. 2016;73:62–70.CrossRefPubMed
79.
Verhagen AP, Bierma-Zeinstra SM, Burdorf A, Stynes SM, de Vet HC, Koes BW. Conservative interventions for treating work-related complaints of the arm, neck or shoulder in adults. Cochrane Database Syst Rev. 2013;12:CD008742.
80.
Sundstrup E, Jakobsen MD, Andersen CH, Jay K, Persson R, Aagaard P, et al. Effect of two contrasting interventions on upper limb chronic pain and disability: a randomized controlled trial. Pain Physician. 2014;17:145–54.PubMed
81.
Hoddinott P, Allan K, Avenell A, Britten J. Group interventions to improve health outcomes: a framework for their design and delivery. BMC Public Health. 2010;10:800.CrossRefPubMedPubMedCentral
Metadata
Title
Reducing shoulder complaints in employees with high occupational shoulder exposures: study protocol for a cluster-randomised controlled study (The Shoulder-Café Study)
Authors
Jeanette Trøstrup
Lone Ramer Mikkelsen
Poul Frost
Annett Dalbøge
Mette Terp Høybye
Sven Dalgas Casper
Lene Bastrup Jørgensen
Thomas Martin Klebe
Susanne Wulff Svendsen
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3703-y

Other articles of this Issue 1/2019

Trials 1/2019 Go to the issue

Study protocol

Parathyroid autotransplantation at a novel site for better evaluation of the grafted gland function: study protocol for a prospective, randomized controlled trial

Research

An evaluation of risk-based monitoring in pragmatic trials in UK Clinical Trials Units

Study protocol

Rationale and design of PASSAT — patients’ satisfaction with local or general anaesthesia in video-assisted thoracoscopic surgery: study protocol for a randomised controlled trial with a non-randomised side arm

Study protocol

Metacognitive therapy versus exposure and response prevention for obsessive-compulsive disorder: study protocol for a randomized controlled trial

Research

Recruitment strategies for predominantly low-income, multi-racial/ethnic children and parents to 3-year community-based intervention trials: Childhood Obesity Prevention and Treatment Research (COPTR) Consortium

Study protocol

Treatment of hospital-acquired pneumonia with multi-drug resistant organism by Buzhong Yiqi decoction based on Fuzheng Quxie classical prescription: study protocol for a randomized controlled trial