Adhesive capsulitis of the shoulder, treatment with corticosteroid, corticosteroid with distension or treatment-as-usual; a randomised controlled trial in primary care

Satya Pal Sharma, Anders Bærheim, Rolf Moe-Nilssen, Alice Kvåle, Satya Pal Sharma, Anders Bærheim, Rolf Moe-Nilssen, Alice Kvåle

Abstract

Background: Optimal management for adhesive shoulder capsulitis (frozen shoulder) is currently unclear. We intended to explore whether treatment by intra-articular injections with corticosteroid and distension is more effective than treating with corticosteroids alone or treatment-as-usual in a primary care setting in Norway.

Methods: In this prospective randomised intention to treat parallel study, 106 patients were block randomised to three groups; 36 (analysed 35) receiving steroid injection and Lidocaine (IS), 34 receiving steroid and additional saline as distension (ISD) and 36 had treatment-as-usual (TAU). Intervention groups received four injections within 8 weeks, assessed on 1st visit, at the 4th and 8th week. Outcomes were Shoulder Pain and Disability Index (SPADI), Numerical pain rating scale (NPRS) and passive range of motion (PROM). Postal assessment was repeated after 1 year for SPADI. Patients in the IS and ISD groups were "blinded" for intervention received and the assessor was "blinded" to group allocation.

Results: At baseline there were no differences between groups in outcome measures. There were no statistical significant differences between the intervention groups in SPADI, NPRS and PROM at baseline, at short-term (4-and 8 weeks) or long-term (12 months). There were statistically significant differences (p < 0.01) in change scores at short-term for SPADI when comparing the IS and TAU groups (-20.8; CI-28.9 to -12.7), and the ISD and TAU groups (-21.7; CI-29.4 to -14.0), respectively for NPRS (-2.0; CI-2.8 to -1.1 and -2.2; CI-3.0 to -1.4), and for PROM, but not at long-term for SPADI (p > 0.05). Effect size (ES) at 8 weeks was large between both injection groups and TAU (ES 1.2). At 12 months ES was reduced to 0.3 and 0.4 respectively. Transitory side effects as flushing and after-pain were reported by 14 % in intervention groups.

Conclusion: This intention to treat RCT in primary care indicates that four injections with corticosteroid with or without distension, given with increasing intervals during 8 weeks, were better than treatment-as-usual in treatment of adhesive shoulder capsulitis. However, in the long run no difference was found between any of the groups, indicating that natural healing takes place independent of treatment or not.

Trial registration: ClinicalTrials.gov, https://ichgcp.net/clinical-trials-registry/NCT01570985" title="See in ClinicalTrials.gov">NCT01570985.

Keywords: Adhesive capsulitis; Corticosteroid; Distension; Frozen shoulder.

Figures

Fig. 1
Fig. 1
Flow diagram for randomisation and follow-up
Fig. 2
Fig. 2
Comparison between intervention and treatment-as-usual groups from inclusion to 52 weeks for SPADI

References

    1. Cyriax J. Textbook of Orthopaedic Medicine. Diagnosis of Soft Tissue lesions. 7. London: Baillie’re Tindall; 1982.
    1. Lorbach O, Anagnostakos K, Scherf C, Seil R, Kohn D, Pape D. Nonoperative management of adhesive capsulitis of the shoulder: oral cortisone application versus intra-articular cortisone injections. J Shoulder Elbow Surg. 2010;19(2):172–179. doi: 10.1016/j.jse.2009.06.013.
    1. Lundberg BJ. Arthrography and Manipulation in Rigidity of the Shoulder Joint. Acta Orthop Scand. 1965;36:35–44. doi: 10.3109/17453676508989369.
    1. Shah N, Lewis M. Shoulder adhesive capsulitis: systematic review of randomised trials using multiple corticosteroid injections. Br J Gen Pract. 2007;57(541):662–667.
    1. Ombregt L, Bisschop P, Veer HJ, Van de Velde T. A System of orthopaedic medicine. London: Saunders; 1995.
    1. Kesson M, Atkins E. Orthopaedic medicine: a practical approach. Oxford: Butterworth-Heinemann; 1998.
    1. Buchbinder R, Green S. Effect of arthrographic shoulder joint distension with saline and corticosteroid for adhesive capsulitis. Br J Sports Med. 2004;38(4):384–385. doi: 10.1136/bjsm.2004.013532.
    1. Dias R, Cutts S, Massoud S. Frozen shoulder. BMJ. 2005;331:1453–1456. doi: 10.1136/bmj.331.7530.1453.
    1. Neviaser TJ. Adhesive capsulitis. Orthop Clin North Am. 1987;18(3):439–443.
    1. Hsu JE, Anakwenze OA, Warrender WJ, Abboud JA. Current review of adhesive capsulitis. J Shoulder Elbow Surg. 2011;20(3):502–514. doi: 10.1016/j.jse.2010.08.023.
    1. Nagy MT, Macfarlane RJ, Khan Y, Waseem M. The frozen shoulder: myths and realities. Open Orthop J. 2013;7:352–355. doi: 10.2174/1874325001307010352.
    1. Wiley AM. Arthroscopic appearance of frozen shoulder. Arthroscopy. 1991;7(2):138–143. doi: 10.1016/0749-8063(91)90098-I.
    1. Bunker TD, Anthony PP. The pathology of frozen shoulder. A Dupuytren-like disease. J Bone Joint Surg (Br) 1995;77:677–683.
    1. Grey RG. The natural history of “idiopathic” frozen shoulder. J Bone Joint Surg Am. 1978;60(4):564.
    1. Miller MD, Wirth MA, Rockwood CA., Jr Thawing the frozen shoulder: the “patient” patient. Orthopedics. 1996;19(10):849–853.
    1. Binder AI, Bulgen DY, Hazleman BL, Roberts S. Frozen shoulder: a long-term prospective study. Ann Rheum Dis. 1984;43(3):361–364. doi: 10.1136/ard.43.3.361.
    1. Hand C, Clipsham K, Rees JL, Carr AJ. Long-term outcome of frozen shoulder. J Shoulder Elbow Surg. 2008;17(2):231–236. doi: 10.1016/j.jse.2007.05.009.
    1. Shaffer B, Tibone JE, Kerlan RK. Frozen shoulder. A long-term follow-up. J Bone Joint Surg Am. 1992;74:738–746.
    1. Hannafin JA, Chiaia TA. Adhesive capsulitis. A treatment approach. Clin Orthop Relat Res. 2000;372:95–109. doi: 10.1097/00003086-200003000-00012.
    1. Reeves B. The natural history of the frozen shoulder syndrome. Scand J Rheumatol. 1975;4(4):193–196. doi: 10.3109/03009747509165255.
    1. Neviaser AS, Hannafin JA. Adhesive Capsulitis. Am J Sports Med. 2010;38(11):2346–2356. doi: 10.1177/0363546509348048.
    1. Griesser MJ, Harris JD, Campbell JE, Jones GL. Adhesive Capsulitis of the Shoulder: a systematic review of the effectiveness of intra-articular corticosteroid injections. J Bone Joint Surg Am. 2011;93:1727–33. doi: 10.2106/JBJS.J.01275.
    1. Blanchard V, Barr S, Cerisola FL. The effectiveness of corticosteroid injections compared with physiotherapeutic interventions for adhesive capsulitis: a systematic review. Physiotherapy. 2010;96(2):95–107. doi: 10.1016/j.physio.2009.09.003.
    1. Green S, Buchbinder R, Glazier R, Forbes A. Systematic review of randomised controlled trials of interventions for painful shoulder: selection criteria, outcome assessment, and efficacy. BMJ. 1998;316(7128):354–360. doi: 10.1136/bmj.316.7128.354.
    1. van der Windt DA, Koes BW, Deville W, Boeke AJ, de Jong BA, Bouter LM. Effectiveness of corticosteroid injections versus physiotherapy for treatment of painful stiff shoulder in primary care: randomised trial. BMJ. 1998;317(7168):1292–1296. doi: 10.1136/bmj.317.7168.1292.
    1. Siegel LB, Cohen NJ, Gall EP. Adhesive capsulitis: a sticky issue. Am Fam Physician. 1999;59(7):1843–1852.
    1. Buchbinder R, Green S, Forbes A, Hall S, Lawler G. Arthrographic joint distension with saline and steroid improves function and reduces pain in patients with painful stiff shoulder: results of a randomised, double blind, placebo controlled trial. Ann Rheum Dis. 2004;63(3):302–309. doi: 10.1136/ard.2002.004655.
    1. Buchbinder R, Green S, Youd JM, Johnston RV, Cumpston M. Arthrographic distension for adhesive capsulitis (frozen shoulder) Cochrane Database Syst Rev. 2008;1:CD007005.
    1. Gam AN, Schydlowsky P, Rossel I, Remvig L, Jensen EM. Treatment of “frozen shoulder” with distension and glucorticoid compared with glucorticoid alone. A randomised controlled trial. Scand J Rheumatol. 1998;27(6):425–430. doi: 10.1080/030097498442244.
    1. Corbeil V, Dussault RG, Leduc BE, Fleury J. [Adhesive capsulitis of the shoulder: a comparative study of arthrography with intra-articular corticotherapy and with or without capsular distension] Can Assoc Radiol J. 1992;43(2):127–130.
    1. Tveita EK, Tariq R, Sesseng S, Juel NG, Bautz-Holter E. Hydrodilatation, corticosteroids and adhesive capsulitis: a randomized controlled trial. BMC Musculoskelet Disord. 2008;9:53. doi: 10.1186/1471-2474-9-53.
    1. Uppal HS, Evans JP, Smith C. Frozen shoulder: A systematic review of therapeutic options. World J Orthop. 2015;6(2):263–268. doi: 10.5312/wjo.v6.i2.263.
    1. Sharma S, Kvåle A, Bærheim A. Outcome in shoulder capsulitis (frozen shoulder) treated with corticosteroid and corticosteroid with distension - a randomised pilot study. Int Musculoskelet Med. 2009;3:5.
    1. Williams JW, Jr, Holleman DR, Jr, Simel DL. Measuring shoulder function with the Shoulder Pain and Disability Index. J Rheumatol. 1995;22(4):727–732.
    1. Green S, Buchbinder R, Forbes A, Bellamy N. A standardized protocol for measurement of range of movement of the shoulder using the Plurimeter-V inclinometer and assessment of its intrarater and interrater reliability. Arthritis Care Res. 1998;11:43–52. doi: 10.1002/art.1790110108.
    1. Hoving JL, Buchbinder R, Green S, Forbes A, Bellamy N, Brand C, Buchanan R, Hall S, Patrick M, Ryan P, et al. How reliably do rheumatologists measure shoulder movement? Ann Rheum Dis. 2002;61:612–616. doi: 10.1136/ard.61.7.612.
    1. Sharma SP, Baerheim A, Kvale A. Passive range of motion in patients with adhesive shoulder capsulitis, an intertester reliability study over eight weeks. BMC Musculoskelet Disord. 2015;16:37. doi: 10.1186/s12891-015-0495-4.
    1. Carette S, Moffet H, Tardif J, Bessette L, Morin F, Fremont P, Bykerk V, Thorne C, Bell M, Bensen W, et al. Intraarticular corticosteroids, supervised physiotherapy, or a combination of the two in the treatment of adhesive capsulitis of the shoulder: a placebo-controlled trial. Arthritis Rheum. 2003;48(3):829–838. doi: 10.1002/art.10954.
    1. Norman GR, Streiner DL. Biostatistics The Bare Essentials. 4. Shelton: People’s Medical Publishing House-USA; 2014.
    1. Lewis JA, Machin D. Intention to treat--who should use ITT? Br J Cancer. 1993;68(4):647–650. doi: 10.1038/bjc.1993.402.
    1. Abraha I, Cherubini A, Cozzolino F, De Florio R, Luchetta ML, Rimland JM, Folletti I, Marchesi M, Germani A, Orso M, et al. Deviation from intention to treat analysis in randomised trials and treatment effect estimates: meta-epidemiological study. BMJ. 2015;350:h2445. doi: 10.1136/bmj.h2445.
    1. Jacobs LG, Barton MA, Wallace WA, Ferrousis J, Dunn NA, Bossingham DH. Intra-articular distension and steroids in the management of capsulitis of the shoulder. BMJ. 1991;302(6791):1498–1501. doi: 10.1136/bmj.302.6791.1498.
    1. Fareed DO, Gallivan WR., Jr Office management of frozen shoulder syndrome. Treatment with hydraulic distension under local anesthesia. Clin Orthop Relat Res. 1989;242:177–183.
    1. Halverson L, Maas R. Shoulder joint capsule distension (hydroplasty): a case series of patients with “frozen shoulders” treated in a primary care office. J Fam Pract. 2002;51(1):61–63.
    1. de Jong BA, Dahmen R, Hogeweg JA, Marti RK. Intra-articular triamcinolone acetonide injection in patients with capsulitis of the shoulder: a comparative study of two dose regimens. Clin Rehabil. 1998;12(3):211–215. doi: 10.1191/026921598673772420.
    1. Yoon SH, Lee HY, Lee HJ, Kwack KS. Optimal Dose of Intra-articular Corticosteroids for Adhesive Capsulitis A Randomized, Triple-Blind, Placebo-Controlled Trial. Am J Sports Med. 2013;41(5):1133–1139. doi: 10.1177/0363546513480475.
    1. Piotte F, Gravel D, Moffet H, Fliszar E, Roy A, Nadeau S, Bedard D, Roy G. Effects of repeated distension arthrographies combined with a home exercise program among adults with idiopathic adhesive capsulitis of the shoulder. Am J Phys Med Rehabil. 2004;83(7):537–546. doi: 10.1097/01.PHM.0000130030.73449.60.
    1. Lee H-J, Lim K-B, Kim D-Y, Lee K-T. Randomized Controlled Trial for Efficacy of Intra-Articular Injection for Adhesive Capsulitis: Ultrasonography-Guided Versus Blind Technique. Arch Phys Med Rehabil. 2009;90(12):1997–2002. doi: 10.1016/j.apmr.2009.07.025.
    1. Vastamäki HMD, Kettunen JPTP, Vastamäki MMDP. The Natural History of Idiopathic Frozen Shoulder: A 2- to 27-year Followup Study. Clin Orthop Relat Res. 2012;470(4):1133–1143. doi: 10.1007/s11999-011-2176-4.
    1. Smith CD, Hamer P, Bunker TD. Arthroscopic capsular release for idiopathic frozen shoulder with intra-articular injection and a controlled manipulation. Ann R Coll Surg Engl. 2014;96(1):55–60. doi: 10.1308/003588414X13824511650452.
    1. Winters JC, Sobel JS, Groenier KH, Arendzen HJ, Meyboom-de Jong B. Comparison of physiotherapy, manipulation, and corticosteroid injection for treating shoulder complaints in general practice: randomised, single blind study. BMJ. 1997;314:1320. doi: 10.1136/bmj.314.7090.1320.

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