Does surgery followed by physiotherapy improve short and long term outcome for patients with atraumatic shoulder instability compared with physiotherapy alone? - protocol for a randomized controlled clinical trial

BMC Musculoskeletal Disorders

Karen A Ginn³  Lennard Funk¹  Robert Herbert²  Susan Alexander⁴  Anju Jaggi⁴ 

[1] Wrightington, Wigan & Leigh NHS Foundation Trust, Wrightington Hospital, Wrightington, UK;Neuroscience Research Australia, Randwick, Australia;Discipline of Biomedical Science, Sydney Medical School, The University of Sydney, Sydney, Australia;Royal National Orthopaedic Hospital NHS Trust, Stanmore, UK

关键词: Musculoskeletal;    Physiotherapy;    Capsular plication;    Stabilization surgery;    Randomized controlled trial;    Shoulder instability;   

Others  :  1090388
DOI  :  10.1186/1471-2474-15-439

 received in 2013-11-01, accepted in 2014-11-19,  发布年份 2014

【 摘 要 】

Background

Shoulder instability is a common problem affecting young adults. Stabilization surgery followed by physiotherapy rehabilitation has been shown to reduce the chance of further episodes of shoulder dislocation and to improve quality of life in patients who sustain a shoulder dislocation as a result of a high collision trauma, but it is unclear if surgical intervention is beneficial for patients with atraumatic shoulder instability who have structural damage at the shoulder. The aim of this randomized controlled clinical trial is to determine if the addition of surgical intervention to physiotherapy rehabilitation improves outcomes for patients with atraumatic shoulder instability who have sustained soft tissue damage at their joint.

Methods/Design

140 participants will be recruited. Patients with feelings of insecurity (apprehension) at their shoulder joint, which is not the result of a collision injury, with physical signs of shoulder joint instability will be invited to participate. Consenting participants will undergo arthroscopic investigation of the shoulder joint. Patients with capsulolabral damage will be randomly allocated using a concealed allocation procedure to either stabilization surgery immediately following the arthroscopic examination or no additional surgical procedure. All participants will then receive the same postoperative physiotherapy protocol for up to 6 months. Outcomes (pain, functional impairment and number of shoulder dislocations sustained) will be evaluated prior to surgery and, together with participant-reported improvement, again at 6, 12 and 24 months after randomization. The primary endpoint will be pain and functional impairment at 2 years. Participants, clinical staff (but not surgeons) and assessors will be blind to whether stabilization surgery was performed. Data analysis will be conducted on an intention-to-treat basis with the focus on estimation of the effect.

Discussion

This trial will have a direct and immediate impact on clinical decision making by establishing if patients presenting with soft tissue shoulder damage associated with atraumatic shoulder instability should be referred for stabilization surgery before commencing physiotherapy rehabilitation in order to ensure optimal outcome. This in turn will ensure effective, efficient use of scarce health resources to manage this common often disabling musculoskeletal condition.

Trial registration

Study was registered with National Institutes of Health Clinical Trials Protocol Registration System in December 2012.

ClinicalTrials.gov Identifier: NCT01751490.

【 授权许可】

   
2014 Jaggi et al.; licensee BioMed Central.

【 参考文献 】

• [1]Ludewig P, Borstead J: The Shoulder Complex. In Joint Structure and Function: A Comprehensive Analysis. 4th edition. Edited by Levangie P, Norkin C. Philadelphia: FA Davis Company; 2005:233-271.
• [2]Gibson K, Growse A, Korda L, Wray E, MacDermid J: The effectiveness of rehabilitation for non-operative management of shoulder instability: a systematic review. J Hand Ther 2004, 17(2):229-242.
• [3]Kirkley A, Griffin S, McLintock H, Ng L: The development and evaluation of a disease-specific quality of life measurement tool for shoulder instability - the Western Ontario ShoulderInstability Index (WOSI). Am J Sports Med 1998, 26(6):764-772.
• [4]Gartsman G, Brinker M, Karahan M: Self assessment of general health status in patients with five common shoulder conditions. J Shoulder Elbow Surg 1998, 7(3):228-237.
• [5]Kirkley A, Werstine R, Ratjek A, Griffin S: Prospective randomized clinical trial comparing the effectiveness of immediate arthroscopic stabilization versus immobilization and rehabilitation in first traumatic anterior dislocations of the shoulder: long term evaluation. J Arthroscopic Rel Surg 2005, 21(1):55-63.
• [6]Kiss J, Damrel D, Mackie A, Neumann L, Wallace W: Non-operative treatment of multidirectional shoulder instability. Int Orthop 2001, 24(6):354-357.
• [7]Kirkley A, Griffin S, Richards C, Miniaci A, Mohtadi N: Prospective randomized clinical trial comparing the effectiveness of immediate arthroscopic stabilization versus immobilization and rehabilitation in first traumatic anterior dislocations of the shoulder. Arthroscopy 1999, 15(5):507-514.
• [8]Arciero R, Wheeler J, Ryan J, McBride J: Arthroscopic Bankart repair versus nonoperative treatment for acute, initial anterior shoulder dislocations. Am J Sports Med 1994, 22(5):589-594.
• [9]Bottoni C, Wilckens J, DeBerardino T, D’Alleyrand J, Rooney R, Harpstrite J, Arciero R: A prospective, randomized evaluation of arthroscopic stabilization versus nonoperative treatment in patients with acute, traumatic, first-time shoulder dislocations. Am J Sports Med 2002, 30(4):576-580.
• [10]Wintzell G, Haglund-Akerlind V, Nowak J, Larsson S: Arthroscopic lavage compared with nonoperative treatment for traumatic primary anterior shoulder dislocation: a 2-year follow-up of a prospective randomized study. J Shoulder Elbow Surg 1999, 8(5):399-402.
• [11]Burkhead W, Rockwood C: Treatment of instability of the shoulder with an exercise program. J Bone Jt Surg Am 1992, 74:890-896.
• [12]Takwale V, Calvert P, Rattue H: Involuntary positional instability of the shoulder in adolescents and young adults - is there any benefit from treatment? J Bone Jt Surg 2000, 82B(5):719-723.
• [13]Baker C, Mascarenhas R, Kline A, Chhabra A, Pombo M, Bradley J: Arthroscopic treatment of multidirectional shoulder instability in athletes. Am J Sports Med 2009, 37(9):1712-1720.
• [14]Engelsma Y, Willems W: Arthroscopic stabilization of posterior shoulder instability. Knee Surg Sports Traumatol Arthrosc 2010, 18:1762-1766.
• [15]Tillander B, Lysholm M, Norlin R: Multidirectional hyperlaxity of the shoulder: results of treatment. Scand J Med Sci Sports 1998, 8(6):421-425.
• [16]Moon Y, Singh H, Tang H, Chul L: Arthroscopic rotator cuff interval closure by purse string suture for symptomatic inferior shoulder instability. Orthopedics 2011., 34(4) doi:10.3928/01477447-20110228-01477402
• [17]Voigt C, Schultz A, Lill H: Arthroscopic treatment of multidirectional glenohumeral instability in young overhead athletes. Open Orthop J 2009, 24(3):107-114.
• [18]Hawkins R, Krishnan S, Karas S, Noonan T, Horan M: Electrothermal arthroscopic shoulder capsulorrhaphy. Am J Sports Med 2007, 35(9):1484-1488.
• [19]Malone A, AJ A, Calvert P: Muscle Patterning Instability – Classification and Prevalence in Reference Shoulder Service. In Surgery of the Shoulder and Elbow: An International Perspective. Edited by Norris T, Zuckerman J, Warner J, Lee Q. Illinois, USA: American Academy of Orthopaedic Surgeons; 2006.
• [20]McAuliffe TB: Failed surgery for anterior dislocation. Am J Sports Med 1988, 70(5):798-801.
• [21]Kalson N, Geoghegan J, Funk L: Magnetic resonance arthrogram and arthroscopy of the shoulder: a comparative retrospective study with emphasison posterior labral lesions and radiologist locality. Shoulder Elbow 2011, 3:210-214.
• [22]Steinbach L: MRI of shoulder instability. Eur J Radiol 2008, 68:57-71.
• [23]Likert R: A technique for the measurement of attitudes. Arch Psych 1932, 83:12-17.
• [24]Chen J, Ginn K, Herbert R: Passive joint mobilisation to shoulder region joints plus advice and exercise does not reduce pain and disability more than advice and exercise alone: a randomised trial. Aust J Physiol 2009, 55:17-23.
• [25]Ginn K, Cohen M: Exercise therapy aimed at restoring neuromuscular control for the treatment of shoulder pain: a randomised comparative clinical trial. J Rehabil Med 2005, 37:115-122.
• [26]Yiasemides R, Halaki M, Cathers I, Ginn K: Does passive joint mobilization of shoulder region joints provide additional benefit over advice and exercise alone for people who have shoulder pain and minimal movement restriction? A randomized controlled trial. Phys Ther 2011, 91(2):178-189.
• [27]Bohannon R: Testing isometric limb strength with dynamometers. Clin Rev Phys Rehabil Med 1990, 2:75-86.
• [28]Kirkley A, Griffin S, Dainty K: Scoring systems for the functional assessment of the shoulder. Arthroscopy 2003, 19(10):1109-1120.
• [29]Ryan P: Random allocation of treatments in blocks. Stata Tech Bull 1998, 41:43-46.
• [30]Pocock S: When (not) to stop a clinical trial for benefit? JAMA 2005, 294(17):2228-2230.
• [31]Altman D, Gardner M: Statistics with Confidence: Confidence Intervals and Statistical Guidelines. 2nd edition. London: BMJ; 2000.
• [32]Vickers AJ, Altman D: Statistics notes: analysing controlled trials with baseline and follow up measurements. BMJ 2001, 323(7321):1123-1124.
• [33]Kenward M, Carpenter J: Multiple imputation: current perspectives. Stat Methods Med Res 2007, 16:199-218.
• [34]Sterne J, White I, Carlin J, Spratt M, Royston P, Kenward M, Wood A: Multiple imputation for missing data in epidemiological and clinical research: potential and pitfalls. BMJ 2009, 338:b2393.
• [35]Dowrick A, Bhandari M: Ethical issues in the design of randomized trials: to sham or not to sham. J Bone Jt Surg Am 2012, 94A(Supp 1(E)):7-10.