The FROSTBLOCK trial: Protocol for a randomized controlled trial of intra-articular corticosteroid injection with or without suprascapular nerve block in frozen shoulder. - 2025
The FROSTBLOCK trial: Protocol for a randomized controlled trial of intra-articular corticosteroid injection with or without suprascapular nerve block in frozen shoulder.
Schiltz, Marc; Croes, Jonas; van Brabander, Linaet al.
[en] [en] BACKGROUND: Frozen shoulder is a challenging musculoskeletal disorder, affecting between 2 and 5% of people, with a higher incidence among those with diabetes and thyroid issues. This condition can persist for years and can be very demanding for both patients and healthcare providers due to the intense pain and restricted shoulder movement. Literature shows that intra-articular corticoid injection (IACI) and suprascapular nerve block (SSNB) can improve pain and range of motion in these patients. The objective of this study is to investigate if there is any significant difference in pain reduction and functional recovery when treated with a combination of gleno-humeral IACI and SSNB compared to a gleno-humeral IACI paired with a placebo SSNB.
METHODS: A two-arm, single-centre, randomized, parallel-group controlled trial will be conducted. Eligible patients will be randomly assigned (1:1 allocation) to long-acting SSNB + IACI and placebo SSNB + IACI. The primary endpoint is the mean change from baseline to 3 months in the Shoulder Pain and Disability Index (SPADI) score. Secondary outcomes will evaluate quality of life, functionality, pain (measured by a Numeric Pain Rating Scale), kinesiophobia, work status, health care service, and a safety assessment. The main paper will be based on the repeated measures collected up to 12 months from baseline.
DISCUSSION: The aim of this study is to determine the additional effect on pain relief and functional improvement in frozen shoulder patients when a long-acting SSNB is administered, compared to a placebo SSNB, in combination with an intra-articular corticosteroid injection. Additionally, we will aim to determine which patients benefit most from these treatments. This study could lead to a change in the standard of care for patients in the painful phase of frozen shoulder.
TRIAL REGISTRATION: ClinicalTrials.gov NCT06229964. Registered on 9 January 2024.
Disciplines :
Orthopedics, rehabilitation & sports medicine
Author, co-author :
Schiltz, Marc ; Department of Physical and Rehabilitation Medicine, Universitair Ziekenhuis Brussel, Laarbeeklaan 101, Brussels, Jette, 1090, Belgium. marc.schiltz@uzbrussel.be ; Department of Physical and Rehabilitation Medicine, Faculty of Medicine and Pharmacy, Vrije Universiteit Brussel, Brussels, Belgium. marc.schiltz@uzbrussel.be ; STIMULUS Consortium, Vrije Universiteit Brussel, Brussels, Belgium. marc.schiltz@uzbrussel.be
Croes, Jonas; Department of Physical and Rehabilitation Medicine, Universitair Ziekenhuis Brussel, Laarbeeklaan 101, Brussels, Jette, 1090, Belgium
van Brabander, Lina; Department of Physical and Rehabilitation Medicine, Universitair Ziekenhuis Brussel, Laarbeeklaan 101, Brussels, Jette, 1090, Belgium
Roggeman, Stijn; Department of Physical and Rehabilitation Medicine, Universitair Ziekenhuis Brussel, Laarbeeklaan 101, Brussels, Jette, 1090, Belgium
Goudman, Lisa; STIMULUS Consortium, Vrije Universiteit Brussel, Brussels, Belgium ; Department of Neurosurgery, Universitair Ziekenhuis Brussel, Brussels, Jette, Belgium ; Center for Neurosciences, Vrije Universiteit Brussel, Brussels, Jette, Belgium ; Pain in Motion Research Group, Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education and Physiotherapy, Brussels, Jette, Belgium ; Research Foundation-Flanders, Brussels, Belgium
Moens, Maarten; STIMULUS Consortium, Vrije Universiteit Brussel, Brussels, Belgium ; Department of Neurosurgery, Universitair Ziekenhuis Brussel, Brussels, Jette, Belgium ; Center for Neurosciences, Vrije Universiteit Brussel, Brussels, Jette, Belgium ; Pain in Motion Research Group, Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education and Physiotherapy, Brussels, Jette, Belgium ; Research Foundation-Flanders, Brussels, Belgium
Nijs, Jo; Department of Physical and Rehabilitation Medicine, Universitair Ziekenhuis Brussel, Laarbeeklaan 101, Brussels, Jette, 1090, Belgium ; Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education and Physiotherapy, Vrije Universiteit Brussel, Brussels, Belgium
Pouliart, Nicole; Department of Orthopaedics and Traumatology, Universitair Ziekenhuis Brussel, Brussels, Belgium ; Faculty of Medicine and Pharmacy, Vrije Universiteit Brussel, Brussels, Belgium
Forthomme, Bénédicte ; Université de Liège - ULiège > Département des Sciences de l'activité physique et de la réadaptation > Rééducation du membre supérieur
Hatem, Samar M; Department of Physical and Rehabilitation Medicine, Universitair Ziekenhuis Brussel, Laarbeeklaan 101, Brussels, Jette, 1090, Belgium ; Department of Physical and Rehabilitation Medicine, Faculty of Medicine and Pharmacy, Vrije Universiteit Brussel, Brussels, Belgium ; STIMULUS Consortium, Vrije Universiteit Brussel, Brussels, Belgium
Language :
English
Title :
The FROSTBLOCK trial: Protocol for a randomized controlled trial of intra-articular corticosteroid injection with or without suprascapular nerve block in frozen shoulder.
Marc Schiltz has received speaker fees from Heel and Ipsen. Lisa Goudman is a postdoctoral research fellow funded by the Research Foundation Flanders (FWO), Belgium (project number 12ZF622N). Maarten Moens has received speaker fees from Medtronic. STIMULUS received independent research grants from Medtronic. The authors declare no competing interests.This study is funded by the Department of Physical Medicine and Rehabilitation of Universitair Ziekenhuis Brussel. The funder does not have a role in the design of the study; the collection, analysis and interpretation of the data; or the writing of the manuscript.
N.H. Zreik R.A. Malik C.P. Charalambous Adhesive capsulitis of the shoulder and diabetes: a meta-analysis of prevalence Muscles Ligaments Tendons J 6 1 26 34 10.32098/mltj.01.2016.04 27331029 4915459
Sarasua SM, Floyd S, Bridges WC, Pill SG. The epidemiology and etiology of adhesive capsulitis in the U.S. Medicare population. BMC Musculoskelet Disord. 2021;22(1). Available from: https://www.embase.com/search/results?subaction=viewrecord&id=L2013801074&from=export.
M.M. Uddin A.A. Khan A.J. Haig M.K. Uddin Presentation of frozen shoulder among diabetic and non-diabetic patients J Clin Orthop Trauma 5 4 193 198 10.1016/j.jcot.2014.09.008 25983497 4264053
K. Wang V. Ho D.J. Hunter-Smith P.S. Beh K.M. Smith A.B. Weber Risk factors in idiopathic adhesive capsulitis: a case control study J Shoulder Elbow Surg 22 7 e24 29 10.1016/j.jse.2012.10.049 23352186
Millar NL, Meakins A, Struyf F, Willmore E, Campbell AL, Kirwan PD, et al. Frozen shoulder. Nat Rev Disease Prim. 2022;8(1). Available from: https://www.embase.com/search/results?subaction=viewrecord&id=L2019024007&from=export.
C.M. Jump K. Duke R.A. Malik C.P. Charalambous Frozen shoulder: a systematic review of cellular, molecular, and metabolic findings JBJS Rev 9 1 e19.00153 10.2106/JBJS.RVW.19.00153 33512972
M.J. Kelley M.A. Shaffer J.E. Kuhn L.A. Michener A.L. Seitz T.L. Uhl et al. Shoulder Pain and Mobility Deficits: Adhesive Capsulitis: Clinical Practice Guidelines Linked to the International Classification of Functioning, Disability, and Health From the Orthopaedic Section of the American Physical Therapy Association J Orthop Sports Phys Ther 43 5 A1 31 10.2519/jospt.2013.0302 23636125
S. Walmsley P.G. Osmotherly D.A. Rivett Clinical identifiers for early-stage primary/idiopathic adhesive capsulitis: are we seeing the real picture? Phys Ther 94 7 968 976 10.2522/ptj.20130398 24652474
M. Fernandes Correlation between functional disability and quality of life in patients with adhesive capsulitis Acta Ortop Bras 23 2 81 84 10.1590/1413-78522015230200791 27069405 4813414
A. Rangan J. Gibson P. Brownson M. Thomas J. Rees R. Kulkarni Frozen Shoulder Should Elb 7 4 299 307 10.1177/1758573215601779
A.S. Neviaser J.A. Hannafin Adhesive capsulitis: a review of current treatment Am J Sports Med 38 11 2346 2356 10.1177/0363546509348048 20110457
A. Song L. Higgins J. Newman N. Jain Glenohumeral corticosteroid injections in adhesive capsulitis: a systematic search and review PM&R 6 12 1143 1156 10.1016/j.pmrj.2014.06.015
D. Challoumas M. Biddle M. McLean N.L. Millar Comparison of treatments for frozen shoulder: a systematic review and meta-analysis JAMA Netw Open 3 12 e2029581 10.1001/jamanetworkopen.2020.29581 33326025 7745103
A. Rangan S.D. Brealey A. Keding B. Corbacho M. Northgraves L. Kottam et al. Management of adults with primary frozen shoulder in secondary care (UK FROST): a multicentre, pragmatic, three-arm, superiority randomised clinical trial Lancet 396 10256 977 989 1:CAS:528:DC%2BB3cXitFyqtb3F 10.1016/S0140-6736(20)31965-6 33010843
S.S. Rex L. Kottam C. McDaid S. Brealey J. Dias C.E. Hewitt et al. Effectiveness of interventions for the management of primary frozen shoulder: a systematic review of randomized trials Bone Jt Open 2 9 773 784 10.1302/2633-1462.29.BJO-2021-0060.R1 34555926 8479840
National Institute for Health and Care Excellence. Shoulder pain: scenario: frozen shoulder. Available through. https://prodigy.clarity.co.ukc/.
Jump CM, Waghmare A, Mati W, Malik RA, Charalambous CP. The impact of suprascapular nerve interventions in patients with frozen shoulder: a systematic review and meta-analysis. JBJS Revi. 2021;9(12). Available from: https://journals.lww.com/10.2106/JBJS.RVW.21.00042. Cited 2022 Dec 8.
Schiltz M, Beeckmans N, Gillard B, De Baere T, Hatem SM. Randomized controlled trial of suprascapular nerve blocks for subacute adhesive capsulitis. Eur J Phys Rehabil Med [Internet]. 2022 Jul [cited 2023 Sep 30];58(4). Available from: https://www.minervamedica.it/index2.php?show=R33Y2022N04A0630.
T.W. Jung S.Y. Lee S.K. Min S.M. Lee J.C. Yoo Does Combining a Suprascapular Nerve Block With an Intra-articular Corticosteroid Injection Have an Additive Effect in the Treatment of Adhesive Capsulitis? A Comparison of Functional Outcomes After Short-term and Minimum 1-Year Follow-up Orthop J Sports Med 7 7 232596711985927 10.1177/2325967119859277
C.H. Cho Y.H. Lee D.H. Kim Y.J. Lim C.S. Baek D.H. Kim Definition, diagnosis, treatment, and prognosis of frozen shoulder: a consensus survey of shoulder specialists Clin Orthop Surg 12 1 60 67 10.4055/cios.2020.12.1.60 32117540 7031440
Zhou X, Obuchowski NA, McClish DK. Statistical Methods in Diagnostic Medicine. 1st ed. Wiley; 2002. (Wiley Series in Probability and Statistics). Available from: https://doi.org/10.1002/9780470317082. Cited 2024 Apr 23.
R.C. Xiao K.C. Walley J.P. DeAngelis A.J. Ramappa Corticosteroid injections for adhesive capsulitis: a review Clin J Sport Med 10.1097/JSM.0000000000000358 27434188
Y. Sun S. Liu S. Chen J. Chen The effect of corticosteroid injection into rotator interval for early frozen shoulder: a randomized controlled trial Am J Sports Med 46 3 663 670 1:CAS:528:DC%2BC1cXivVamsL8%3D 10.1177/0363546517744171 29268022
S.H. Yoon H.Y. Lee H.J. Lee K.S. Kwack Optimal dose of intra-articular corticosteroids for adhesive capsulitis: a randomized, triple-blind, placebo-controlled trial Am J Sports Med 41 5 1133 1139 10.1177/0363546513480475 23507791
K.H. Kim J.W. Park S.J. Kim High- vs low-dose corticosteroid injection in the treatment of adhesive capsulitis with severe pain: a randomized controlled double-blind study Pain Med 19 4 735 741 10.1093/pm/pnx227 29117299
Y. Sun P. Zhang S. Liu H. Li J. Jiang S. Chen et al. Intra-articular steroid injection for frozen shoulder: a systematic review and meta-analysis of randomized controlled trials with trial sequential analysis Am J Sports Med 45 9 2171 2179 10.1177/0363546516669944 28298050
Zufferey PJ, Chaux R, Lachaud PA, Capdevila X, Lanoiselée J, Ollier E. Dose–response relationships of intravenous and perineural dexamethasone as adjuvants to peripheral nerve blocks: a systematic review and model-based network meta-analysis. Bri J Anaesthesia. 2024;0(0). Available from: https://www.bjanaesthesia.org/article/S0007-0912(23)00738-9/fulltext. Cited 2024 Feb 26.
P.W.H. Peng M.J. Wiley J. Liang G.A. Bellingham Ultrasound-guided suprascapular nerve block: a correlation with fluoroscopic and cadaveric findings Can J Anaesth 57 2 143 148 10.1007/s12630-009-9234-3 20052627
D. Harmon C. Hearty Ultrasound-guided suprascapular nerve block technique Pain Physician 10 6 743 746 17987095
B. Elnady E. Rageh M. Hussein M. Abu-Zaid D. Desouky T. Ekhouly et al. In shoulder adhesive capsulitis, ultrasound-guided anterior hydrodilatation in rotator interval is more effective than posterior approach: a randomized controlled study Clin Rheumatol 39 12 3805 14 10.1007/s10067-020-05131-2 32385765 7667953
D. Venturin G. Giannotta L. Pellicciari A. Rossi D. Pennella M. Goffredo et al. Reliability and validity of the Shoulder Pain and Disability Index in a sample of patients with frozen shoulder BMC Musculoskelet Disord 24 1 212 10.1186/s12891-023-06268-2 36949437 10032005
C. Kahl J.A. Cleland Visual analogue scale, numeric pain rating scale and the McGill pain questionnaire: an overview of psychometric properties Phys Ther Rev 10 2 123 128 10.1179/108331905X55776
C.R. Constant A.H. Murley A clinical method of functional assessment of the shoulder Clin Orthop Relat Res 214 Jan 160 4 10.1097/00003086-198701000-00023
J.S. Roy J.C. MacDermid L.J. Woodhouse A systematic review of the psychometric properties of the Constant-Murley score J Shoulder Elbow Surg 19 1 157 164 10.1016/j.jse.2009.04.008 19559630
E.C. Makhni M. Meadows J.T. Hamamoto J.D. Higgins A.A. Romeo N.N. Verma Patient reported outcomes measurement information system (PROMIS) in the upper extremity: the future of outcomes reporting? J Shoulder Elbow Surg 26 2 352 7 10.1016/j.jse.2016.09.054 28104094
J.S. Sabari I. Maltzev D. Lubarsky E. Liszkay P. Homel Goniometric assessment of shoulder range of motion: comparison of testing in supine and sitting positions Arch Phys Med Rehabil 79 6 647 651 1:STN:280:DyaK1c3pt1Sqtw%3D%3D 10.1016/S0003-9993(98)90038-7 9630143
Schiltz M, Goudman L, Moens M, Nijs J, Hatem SM. The diagnostic value of physical examination tests in adhesive capsulitis: a systematic review. Eur J Phys Rehabil Med. 2023.Available from: https://www.minervamedica.it/index2.php?show=R33Y9999N00A23092202. Cited 2023 Sep 30.
Mertens MGCAM, Meeus M, Pieters L, Balasch-Bernat M, Dueñas L, Verborgt O, et al. An Instrument-Assisted Coracoid Pain Test: An Exploratory Diagnostic Accuracy Study. Int J Environ Res Public Health. 2022;19(19). Available from: https://www.embase.com/search/results?subaction=viewrecord&id=L2019545546&from=export.
E. Noboa G. López-Graña R. Barco S. Antuña Distension test in passive external rotation: Validation of a new clinical test for the early diagnosis of shoulder adhesive capsulitis Rev Esp Cir Ortop Traumatol 59 5 354 359 1:STN:280:DC%2BC2MvitFGisw%3D%3D 25544715
Szende A, Janssen B, Cabases J, editors. Self-Reported Population Health: An International Perspective based on EQ-5D. Dordrecht (NL): Springer; 2014. Available from: http://www.ncbi.nlm.nih.gov/books/NBK500356/. Cited 2024 Jan 28.
P.E. Mintken J.A. Cleland J.M. Whitman S.Z. George Psychometric properties of the fear-avoidance beliefs questionnaire and Tampa scale of kinesiophobia in patients with shoulder pain Arch Phys Med Rehabil 91 7 1128 1136 10.1016/j.apmr.2010.04.009 20599053
S.R. Woby N.K. Roach M. Urmston P.J. Watson Psychometric properties of the TSK-11: a shortened version of the Tampa Scale for Kinesiophobia Pain 117 1–2 137 144 10.1016/j.pain.2005.05.029 16055269
M.O. Dubé M. Roos F. Desmeules J.S. Roy Reliability, validity, and responsiveness of a Canadian French adaptation of the pain self-efficacy questionnaire (PSEQ) Disabil Rehabil 45 16 2675 2682 10.1080/09638288.2022.2102254 35867979
C. Garrison C. Cook Clinimetrics corner: the Global Rating of Change Score (GRoC) poorly correlates with functional measures and is not temporally stable Journal of Manual & Manipulative Therapy 20 4 178 181 10.1179/1066981712Z.00000000022
J. Ilmarinen Work ability–a comprehensive concept for occupational health research and prevention Scand J Work Environ Health 35 1 1 5 10.5271/sjweh.1304 19277432
T.A. Holt D. Mant A. Carr S. Gwilym D. Beard C. Toms et al. Corticosteroid injection for shoulder pain: single-blind randomized pilot trial in primary care Trials 10 14 425 10.1186/1745-6215-14-425
Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340(mar23 1):c332–c332.
J. Roy J.C. MacDermid L.J. Woodhouse Measuring shoulder function: A systematic review of four questionnaires Arthritis Rheum 61 5 623 632 10.1002/art.24396 19405008
Bilsborough Smith C, Nadesan K, Cairns M, Chester R, Lewis J. Living with frozen shoulder. ‘Here are the risks. I want the injection’. An interpretative phenomenological analysis. Musculoskeletal Science and Practice. 2023;65:102755.
