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BMC Musculoskeletal Disorders
Published in: BMC Musculoskeletal Disorders 1/2016

Open Access 01-12-2016 | Study protocol

Exercise and load modification versus corticosteroid injection versus ‘wait and see’ for persistent gluteus medius/minimus tendinopathy (the LEAP trial): a protocol for a randomised clinical trial

Authors: Rebecca Mellor, Alison Grimaldi, Henry Wajswelner, Paul Hodges, J. Haxby Abbott, Kim Bennell, Bill Vicenzino

Published in: BMC Musculoskeletal Disorders | Issue 1/2016

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Abstract

Background

Lateral hip pain is common, particularly in females aged 40–60 years. The pain can affect sleep and daily activities, and is frequently recalcitrant. The condition is often diagnosed as trochanteric bursitis, however radiological and surgical studies have revealed that the most common pathology is gluteus medius/minimus tendinopathy. Patients are usually offered three treatment options: (a) corticosteroid injection (CSI), (b) physiotherapy, or (c) reassurance and observation. Research on Achilles and patellar tendons has shown that load modification and exercise appears to be more effective than other treatments for managing tendinopathy, however, it is unclear whether a CSI, or a load modification and exercise-based physiotherapy approach is more effective in gluteal tendinopathy. This randomised controlled trial aims to compare the efficacy on pain and function of a load modification and exercise-based programme with a CSI and a ‘wait and see’ approach for gluteal tendinopathy.

Methods

Two hundred one people with gluteal tendinopathy will be randomly allocated into one of three groups: (i) CSI; (ii) physiotherapist-administered load modification and exercise intervention; and (iii) wait and see approach. The CSI therapy will consist of one ultrasound (US) guided CSI around the affected tendons and advice on tendon care. Education about load modification will be delivered in physiotherapy clinics and the exercise programme will be both home-based and supervised. The group allocated the wait and see approach will receive basic tendon care advice and reassurance in a single session by a trial physiotherapist. Outcomes will be evaluated at baseline, 4, 8, 12, 26 and 52 weeks using validated global rating of change, pain and physical function scales, psychological measures, quality of life and physical activity levels. Hip abductor muscle strength will be measured at baseline and 8 weeks. Economic evaluation will be performed to investigate the cost-effectiveness of the active interventions compared with the wait and see approach. Analyses will be conducted on an intention-to-treat basis using logistic and linear mixed regression models and the economic evaluation will report incremental cost-utility ratios. The trial reporting will comply with CONSORT guidelines.

Discussion

This study will provide clinicians with directly applicable evidence of the relative efficacy of three common approaches to the management of gluteal tendinopathy.

Trial registration

Australia New Zealand Clinical Trials Registry ACTRN12612001126​808. Date Registered: 22/10/2012.
Appendix
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Literature
1.
Bird PA et al. Prospective evaluation of magnetic resonance imaging and physical examination findings in patients with greater trochanteric pain syndrome. Arthritis Rheum. 2001;44(9):2138–45.CrossRefPubMed
2.
Kingzett-Taylor A et al. Tendinosis and tears of gluteus medius and minimus muscles as a cause of hip pain: MR imaging findings. AJR Am J Roentgenol. 1999;173(4):1123–6.CrossRefPubMed
3.
Kong A, Van der Vliet A, Zadow S. MRI and US of gluteal tendinopathy in greater trochanteric pain syndrome. Eur Radiol. 2007;17(7):1772–83.CrossRefPubMed
4.
Alvarez-Nemegyei J, Canoso JJ. Evidence-based soft tissue rheumatology: III: trochanteric bursitis. J Clin Rheumatol. 2004;10(3):123–4.CrossRefPubMed
5.
6.
Williams BS, Cohen SP. Greater trochanteric pain syndrome: a review of anatomy, diagnosis and treatment. Anesth Analg. 2009;108(5):1662–70.CrossRefPubMed
7.
Albers IS et al. Incidence and prevalence of lower extremity tendinopathy in a Dutch general practice population: a cross sectional study. BMC Musculoskelet Disord. 2016;17(1):16.CrossRefPubMedPubMedCentral
8.
Fearon AM, et al. Greater Trochanteric Pain Syndrome Negatively Affects Work, Physical Activity and Quality of Life: A Case Control Study. J Arthroplast. 2014;29(2):383–86.CrossRef
9.
Maffulli N, Wong J, Almekinders LC. Types and epidemiology of tendinopathy. Clin Sports Med. 2003;22(4):675–92.CrossRefPubMed
10.
Anderson K, Strickland SM, Warren R. Hip and groin injuries in athletes. Am J Sports Med. 2001;29(4):521–33.PubMed
11.
Blankenbaker DG et al. Correlation of MRI findings with clinical findings of trochanteric pain syndrome. Skelet Radiol. 2008;37(10):903–9.CrossRef
12.
13.
Rompe JD et al. Home training, local corticosteroid injection, or radial shock wave therapy for greater trochanter pain syndrome. Am J Sports Med. 2009;37(10):1981–90.CrossRefPubMed
14.
Almekinders LC, Weinhold PS, Maffulli N. Compression etiology in tendinopathy. Clin Sports Med. 2003;22(4):703–10.CrossRefPubMed
15.
Cook JL, Purdam C. Is compressive load a factor in the development of tendinopathy? Br J Sports Med. 2012;46(3):163–8.CrossRefPubMed
16.
Jonsson P et al. New regimen for eccentric calf-muscle training in patients with chronic insertional Achilles tendinopathy: results of a pilot study. Br J Sports Med. 2008;42(9):746–9.CrossRefPubMed
17.
Birnbaum K et al. Anatomical and biomechanical investigations of the iliotibial tract. Surg Radiol Anat. 2004;26(6):433–46.CrossRefPubMed
18.
Labrosse JM et al. Effectiveness of ultrasound-guided corticosteroid injection for the treatment of gluteus medius tendinopathy. Am J Roentgenol. 2010;194(1):202–6.CrossRef
19.
Brinks A et al. Corticosteroid injections for greater trochanteric pain syndrome: a randomized controlled trial in primary care. Ann Fam Med. 2011;9(3):226–34.CrossRefPubMedPubMedCentral
20.
Coombes BK, Bisset L, Vicenzino B. Efficacy and safety of corticosteroid injections and other injections for management of tendinopathy: a systematic review of randomised controlled trials. Lancet. 2010;376(9754):1751–67.CrossRefPubMed
21.
Bisset L et al. Mobilisation with movement and exercise, corticosteroid injection, or wait and see for tennis elbow: randomised trial. BMJ. 2006;333(7575):939.CrossRefPubMedPubMedCentral
22.
23.
Woodley SJ et al. Lateral hip pain: findings from magnetic resonance imaging and clinical examination. J Orthop Sports Phys Ther. 2008;38(6):313–28.CrossRefPubMed
24.
Reiman MP, Loudon JK, Goode AP. Diagnostic accuracy of clinical tests for assessment of hamstring injury: a systematic review. J Orthop Sports Phys Ther. 2013;43(4):223–31.CrossRefPubMed
25.
Delp SL et al. Variation of rotation moment arms with hip flexion. J Biomech. 1999;32(5):493–501.CrossRefPubMed
26.
Lequesne M et al. Gluteal tendinopathy in refractory greater trochanter pain syndrome: diagnostic value of two clinical tests. Arthritis Rheum. 2008;59(2):241–6.CrossRefPubMed
27.
Fearon AM, et al. Greater trochanteric pain syndrome: defining the clinical syndrome. Br J Sports Med. 2012;47(10):649–53.CrossRefPubMed
28.
Maitland GD. Peripheral manipulation. 3rd ed. London: Butterworth-Heineman; 1991.
29.
30.
31.
Kamper SJ, Maher CG, Mackay G. Global rating of change scales: a review of strengths and weaknesses and considerations for design. J Man Manip Ther. 2009;17(3):163–70.CrossRefPubMedPubMedCentral
32.
ten Klooster PM et al. Patient-perceived satisfactory improvement (PPSI): interpreting meaningful change in pain from the patient’s perspective. Pain. 2006;121(1–2):151–7.CrossRefPubMed
33.
Abbott JH, Schmitt J. Minimum important differences for the patient-specific functional scale, 4 region-specific outcome measures, and the numeric pain rating scale. J Orthop Sports Phys Ther. 2014;44(8):560–4.CrossRefPubMed
34.
Stark T et al. Hand-held dynamometry correlation with the gold standard isokinetic dynamometry: a systematic review. PM R. 2011;3(5):472–9.CrossRefPubMed
35.
Ireland ML et al. Hip strength in females with and without patellofemoral pain. J Orthop Sports Phys Ther. 2003;33(11):671–6.CrossRefPubMed
36.
Thorborg K et al. Clinical assessment of hip strength using a hand-held dynamometer is reliable. Scand J Med Sci Sports. 2010;20(3):493–501.CrossRefPubMed
37.
Robinson JM et al. The VISA-A questionnaire: a valid and reliable index of the clinical severity of Achilles tendinopathy. Br J Sports Med. 2001;35(5):335–41.CrossRefPubMedPubMedCentral
38.
Visentini PJ et al. 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 Sports. 1998;1(1):22–8.CrossRef
39.
Fearon AM, et al. Development and validation of a VISA tendinopathy questionnaire for greater trochanteric pain syndrome, the VISA-G. Man Ther. 2015;20(6):805–13.CrossRefPubMed
40.
Horn KK et al. The patient-specific functional scale: psychometrics, clinimetrics, and application as a clinical outcome measure. J Orthop Sports Phys Ther. 2012;42(1):30–42.CrossRefPubMed
41.
Young IA et al. Reliability, construct validity, and responsiveness of the neck disability index, patient-specific functional scale, and numeric pain rating scale in patients with cervical radiculopathy. Am J Phys Med Rehabil. 2010;89(10):831–9.CrossRefPubMed
42.
Abbott JH, Schmitt JS. The Patient-Specific Functional Scale was valid for group-level change comparisons and between-group discrimination. J Clin Epidemiol. 2014;67(6):681–8.CrossRefPubMed
43.
Stratford PW et al. Assessing disability and change on individual patients: a report of a patient specific measure. Physiother Can. 1995;47:258–62.CrossRef
44.
Nicholas MK. The pain self-efficacy questionnaire: Taking pain into account. European Journal of Pain. 2007;11(2):153–63.CrossRefPubMed
45.
46.
Sullivan MJ, Bishop SR, Pivik J. The pain catastrophizing scale: development and validation. Psychol Assess. 1995;7(4):524–32.CrossRef
47.
48.
Timperio A, Salmon J, Bull F. Validation of adult physical activity questions for use in Australian population surveys. A.I.o.H.a. Aging, Editor. Canberra; 2002.
49.
Gusi N, Olivares PR, Rajendram R. The EQ-5D Health-Related Quality of Life Questionnaire. In: Preedy VR, Watson RR, editors. Handbook of disease burdens and quality of life measures. New York: Springer; 2010. p. 87–99.CrossRef
50.
Pinto D et al. Good agreement between questionnaire and administrative databases for health care use and costs in patients with osteoarthritis. BMC Med Res Methodol. 2011;11:45.CrossRefPubMedPubMedCentral
51.
Leopold SS, Battista V, Oliverio JA. Safety and efficacy of intraarticular hip injection using anatomic landmarks. Clin Orthop Relat Res. 2001;391:192–7.CrossRef
52.
53.
Smidt N et al. Corticosteroid injections, physiotherapy, or a wait-and-see policy for lateral epicondylitis: a randomised controlled trial. Lancet. 2002;359(9307):657–62.CrossRefPubMed
54.
Schulz KF et al. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA. 1995;273(5):408–12.CrossRefPubMed
55.
Altman DG et al. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med. 2001;134(8):663–94.CrossRefPubMed
Metadata
Title
Exercise and load modification versus corticosteroid injection versus ‘wait and see’ for persistent gluteus medius/minimus tendinopathy (the LEAP trial): a protocol for a randomised clinical trial
Authors
Rebecca Mellor
Alison Grimaldi
Henry Wajswelner
Paul Hodges
J. Haxby Abbott
Kim Bennell
Bill Vicenzino
Publication date
01-12-2016
Publisher
BioMed Central
Published in
BMC Musculoskeletal Disorders / Issue 1/2016
Electronic ISSN: 1471-2474
DOI
https://doi.org/10.1186/s12891-016-1043-6

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