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

Volumn 16, Issue 1, 2015, Pages

  Beard, David ^a   Rees, Jonathan ^a   Rombach, Ines ^a   Cooper, Cushla ^a   Cook, Jonathan ^a   Merritt, Naomi ^a   Gray, Alastair ^a   Gwilym, Stephen ^a   Judge, Andrew ^a   Savulescu, Julian ^b   Moser, Jane ^a   Donovan, Jenny ^c   Jepson, Marcus ^c   Wilson, Caroline ^c   Tracey, Irene ^d   Wartolowska, Karolina ^a   Dean, Benjamin ^a   Carr, Andrew ^a   Jones, Anthony ^e   Rangan, Amar ^f   Hutchinson, James ^g   Conboy, Veronica ^h   Costa, Matthew ⁱ   Stanton, Louise ^j   Brealey, Stephen ^k   Bowers, Megan ^j   more..

^a UNIVERSITY OF OXFORD   (United Kingdom)

^b UNIVERSITY OF OXFORD   (United Kingdom)

^c UNIVERSITY OF BRISTOL   (United Kingdom)

^d JOHN RADCLIFFE HOSPITAL   (United Kingdom)

^e UNIVERSITY OF MANCHESTER   (United Kingdom)

^f JAMES COOK UNIVERSITY HOSPITAL   (United Kingdom)

^g UNIVERSITY OF ABERDEEN   (United Kingdom)

^h TORBAY HOSPITAL   (United Kingdom)

ⁱ UNIVERSITY OF WARWICK   (United Kingdom)

^j UNIVERSITY OF SOUTHAMPTON   (United Kingdom)

^k UNIVERSITY OF YORK   (United Kingdom)

more..

Author keywords

Acromion; Arthroscopy; Placebo; Randomise; Sham; Shoulder; Trial; Waiting list

Indexed keywords

PLACEBO;

ARTHROSCOPIC SUBACROMIAL DECOMPRESSION; ARTHROSCOPIC SURGERY; ARTICLE; CLINICAL EFFECTIVENESS; CONSERVATIVE TREATMENT; COST EFFECTIVENESS ANALYSIS; DECOMPRESSION SURGERY; DOUBLE BLIND PROCEDURE; FOLLOW UP; HUMAN; INTENTION TO TREAT ANALYSIS; INTERVENTION STUDY; MEDICAL SPECIALIST; MULTICENTER STUDY (TOPIC); OSTEOPHYTE; OUTCOME ASSESSMENT; OXFORD SHOULDER SCORE; PARALLEL DESIGN; PATIENT SATISFACTION; PLACEBO EFFECT; POSTOPERATIVE COMPLICATION; QUALITATIVE RESEARCH; RANDOMIZED CONTROLLED TRIAL (TOPIC); RANGE OF MOTION; SENSITIVITY ANALYSIS; SHOULDER ARTHROSCOPY; SHOULDER PAIN; UNITED KINGDOM; ACROMION; ADVERSE EFFECTS; ARTHROSCOPY; CLINICAL PROTOCOL; CLINICAL TRIAL; CONTROLLED STUDY; COST BENEFIT ANALYSIS; ECONOMICS; FEMALE; HEALTH CARE COST; MALE; METHODOLOGY; MULTICENTER STUDY; PAIN MEASUREMENT; PATHOPHYSIOLOGY; PREDICTIVE VALUE; PROCEDURES; RANDOMIZED CONTROLLED TRIAL; SAMPLE SIZE; TIME FACTOR; TREATMENT OUTCOME;

ACROMION; ARTHROSCOPY; CLINICAL PROTOCOLS; COST-BENEFIT ANALYSIS; DECOMPRESSION, SURGICAL; FEMALE; HEALTH CARE COSTS; HUMANS; INTENTION TO TREAT ANALYSIS; MALE; OSTEOPHYTE; PAIN MEASUREMENT; PATIENT SATISFACTION; POSTOPERATIVE COMPLICATIONS; PREDICTIVE VALUE OF TESTS; RESEARCH DESIGN; SAMPLE SIZE; SHOULDER PAIN; TIME FACTORS; TREATMENT OUTCOME; UNITED KINGDOM;

EID: 84930207324     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/s13063-015-0725-y     Document Type: Article

References (48)

1. Urwin M, Symmons D, Allison T, Brammah T, Busby H, Roxby M, et al. Estimating the burden of musculoskeletal disorders in the community: the comparative prevalence of symptoms at different anatomical sites, and the relation to social deprivation. Ann Rheum Dis. 1998;57(11):649-55.
2. Mitchell C, Adebajo A, Hay E, Carr A. Shoulder pain: diagnosis and management in primary care. Br Med J. 2005;331(7525):1124-1128A.
3. Harkness EF, Macfarlane GJ, Nahit ES, Silman AJ, McBeth J. Mechanical and psychosocial factors predict new onset shoulder pain: a prospective cohort study of newly employed workers. Occup Environ Med. 2003;60(11):850-7.
4. van der Windt DAWM, Thomas E, Pope DP, de Winter AF, Macfarlane GJ, Bouter LM, et al. Occupational risk factors for shoulder pain: a systematic review. Occup Environ Med. 2000;57(7):433-42.
5. Linsell L, Dawson J, Zondervan K, Rose P, Randall T, Fitzpatrick R, et al. Prevalence and incidence of adults consulting for shoulder conditions in UK primary care; patterns of diagnosis and referral. Rheumatology. 2006;45(2):215-21.
6. Oh LS, Wolf BR, Hall MP, Levy BA, Marx RG. Indications for rotator cuff repair: a systematic review. Clin Orthop Relat Res. 2007;455:52-63.
7. van der Windt DA, Koes BW, Boeke AJ, Deville W, De Jong BA, Bouter LM. Shoulder disorders in general practice: prognostic indicators of outcome. Br J Gen Pract. 1996;46(410):519-23.
8. Neer CS. Anterior acromioplasty for the chronic impingement syndrome in the shoulder. J Bone Joint Surg Am. 2005;87A(6):1399.
9. Lewis JS. Rotator cuff tendinopathy/subacromial impingement syndrome: is it time for a new method of assessment? Br J Sports Med. 2009;43(4):259-64.
10. Cummins CA, Sasso LM, Nicholson D. Impingement syndrome: temporal outcomes of nonoperative treatment. J Shoulder Elbow Surg. 2009;18(2):172-7.
11. Coghlan JA, Buchbinder R, Green S, Johnston RV, Bell SN. Surgery for rotator cuff disease. Cochrane Database Syst Rev. 2008(1):CD005619. doi: 10.1002/14651858.CD005619.pub2.
12. Dorrestijn O, Stevens M, Winters JC, van der Meer K, Diercks RL. Conservative or surgical treatment for subacromial impingement syndrome? A systematic review. J Shoulder Elbow Surg. 2009;18(4):652-60.
13. Ketola S, Lehtinen J, Arnala I, Nissinen M, Westenius H, Sintonen H, et al. Does arthroscopic acromioplasty provide any additional value in the treatment of shoulder impingement syndrome? A two-year randomised controlled trial. J Bone Joint Surg Br. 2009;91(10):1326-34.
14. Fukuda H, Mikasa M, Yamanaka K. Incomplete thickness rotator cuff tears diagnosed by subacromial bursography. Clin Orthop Relat Res. 1987;223:51-8.
15. Cordasco FA, Backer M, Craig EV, Klein D, Warren RF. The partial-thickness rotator cuff tear: is acromioplasty without repair sufficient? Am J Sports Med. 2002;30(2):257-60.
16. Snyder SJ, Pachelli AF, Del Pizzo W, Friedman MJ, Ferkel RD, Pattee G. Partial thickness rotator cuff tears: results of arthroscopic treatment. Arthroscopy. 1991;7(1):1-7.
17. Vitale MA, Arons RR, Hurwitz S, Ahmad CS, Levine WN. The rising incidence of acromioplasty. J Bone Joint Surg Am. 2010;92(9):1842-50.
18. Yu E, Cil A, Harmsen WS, Schleck C, Sperling JW, Cofield RH. Arthroscopy and the dramatic increase in frequency of anterior acromioplasty from 1980 to 2005: an epidemiologic study. Arthroscopy. 2010;26(9 Suppl):S142-7.
19. Goldberg BA, Lippitt SB, Matsen FA. Improvement in comfort and function after cuff repair without acromioplasty. Clin Orthop Relat Res.2001;390:142-50.
20. Gartsman GM, O'Connor DP. Arthroscopic rotator cuff repair with and without arthroscopic subacromial decompression: a prospective, randomized study of one-year outcomes. J Shoulder Elbow Surg. 2004;13(4):424-6.
21. Ellman H, Kay SP. Arthroscopic subacromial decompression for chronic impingement. Two- to five-year results. J Bone Joint Surg Br. 1991;73(3):395-8.
22. Nutton RW, McBirnie JM, Phillips C. Treatment of chronic rotator-cuff impingement by arthroscopic subacromial decompression. J Bone Joint Surg Br. 1997;79(1):73-6.
23. Olsewski JM, Depew AD. Arthroscopic subacromial decompression and rotator cuff debridement for stage-II and stage-III impingement. Arthroscopy. 1994;10(1):61-8.
24. Patel VR, Singh D, Calvert PT, Bayley JIL. Arthroscopic subacromial decompression: results and factors affecting outcome. J Shoulder Elbow Surg. 1999;8(3):231-7.
25. Checroun AJ, Dennis MG, Zuckerman JD JD. Open versus arthroscopic decompression for subacromial impingement. A comprehensive review of the literature from the last 25 years. Bull Hosp Jt Dis. 1998;57(3):145-51.
26. Chin PYK, Sperling JW, Cofield RH, Stuart MJ, Crownhart BS. Anterior acromioplasty for the shoulder impingement syndrome: long-term outcome. J Shoulder Elbow Surg. 2007;16(6):697-700.
27. Henkus HE, de Witte PB, Nelissen RGHH, Brand R, van Arkel ERA. Bursectomy compared with acromioplasty in the management of subacromial impingement syndrome: a prospective randomised study. J Bone Joint Surg Br. 2009;91(4):504-10.
28. Moseley JB, O'Malley K, Petersen NJ, Menke TJ, Brody BA, Kuykendall DH, et al. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med. 2002;347(2):81-8.
29. Wartolowska K, Judge A, Hopewell S, Collins GS, Dean BJ, Rombach I, et al. Use of placebo controls in the evaluation of surgery: systematic review. BMJ. 2014;348:g3253.
30. Donovan JL, de Salis I, Toerien M, Paramasivan S, Hamdy FC, Blazeby JM. The intellectual challenges and emotional consequences of equipoise contributed to the fragility of recruitment in six randomized controlled trials. J Clin Epidemiol. 2014;67(8):912-20.
31. Treweek S, Mitchell E, Pitkethly M, Cook J, Kjeldstrom M, Taskila T, et al. Strategies to improve recruitment to randomised controlled trials. Cochrane Database Syst Rev. 2010;1:MR000013.
32. de Salis I, Tomlin Z, Toerien M, Donovan J. Qualitative research to improve RCT recruitment: issues arising in establishing research collaborations. Contemp Clin Trials. 2008;29(5):663-70.
33. Wade J, Donovan JL, Lane JA, Neal DE, Hamdy FC. It's not just what you say, it's also how you say it: opening the 'black box' of informed consent appointments in randomised controlled trials. Soc Sci Med. 2009;68(11):2018-28.
34. Paramasivan S, Huddart R, Hall E, Lewis R, Birtle A, Donovan JL. Key issues in recruitment to randomised controlled trials with very different interventions: a qualitative investigation of recruitment to the SPARE trial (CRUK/07/011). Trials. 2011;12:78.
35. Mills EJ, Seely D, Rachlis B, Griffith L, Wu P, Wilson K, et al. Barriers to participation in clinical trials of cancer: a meta-analysis and systematic review of patient-reported factors. Lancet Oncol. 2006;7(2):141-8.
36. Howard L, de Salis I, Tomlin Z, Thornicroft G, Donovan J. Why is recruitment to trials difficult? An investigation into recruitment difficulties in an RCT of supported employment in patients with severe mental illness. Contemp Clin Trials. 2009;30(1):40-6.
37. Donovan J, Mills N, Smith M, Brindle L, Jacoby A, Peters T, et al. Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. BMJ. 2002;325(7367):766-70.
38. Donovan JL, Lane JA, Peters TJ, Brindle L, Salter E, Gillatt D, et al. Development of a complex intervention improved randomization and informed consent in a randomized controlled trial. J Clin Epidemiol. 2009;62(1):29-36.
39. Dawson J, Rogers K, Fitzpatrick R, Carr A. The Oxford shoulder score revisited. Arch Orthop Trauma Surg. 2009;129(1):119-23.
40. Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987;214:160-4.
41. Freynhagen R, Baron R, Gockel U, Tolle TR. painDETECT: a new screening questionnaire to identify neuropathic components in patients with back pain. Curr Med Res Opin. 2006;22(10):1911-20.
42. Gwilym SE, Keltner JR, Warnaby CE, Carr AJ, Chizh B, Chessell I, et al. Psychophysical and functional imaging evidence supporting the presence of central sensitization in a cohort of osteoarthritis patients. Arthritis Rheum. 2009;61(9):1226-34.
43. Henn 3rd RF, Kang L, Tashjian RZ, Green A. Patients' preoperative expectations predict the outcome of rotator cuff repair. J Bone Joint Surg Am. 2007;89(9):1913-9.
44. Rees JL, Dawson J, Hand GCR, Cooper C, Judge A, Price AJ, et al. The use of patient-reported outcome measures and patient satisfaction ratings to assess outcome in hemiarthroplasty of the shoulder. J Bone Joint Surg Br. 2010;92(8):1107-11.
45. Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002;52(2):69-77.
46. Razmjou H, Schwartz CE, Holtby R. The impact of response shift on perceived disability two years following rotator cuff surgery. J Bone Joint Surg Am. 2010;92(12):2178-86.
47. Matthews TJW, Hand GC, Rees JL, Athanasou NA, Carr AJ. Pathology of the torn rotator cuff tendon. Reduction in potential for repair as tear size increases. J Bone Joint Surg Br. 2006;88(4):489-95.
48. Gotoh M, Hamada K, Yamakawa H, Inoue A, Fukuda H. Increased substance P in subacromial bursa and shoulder pain in rotator cuff diseases. J Orthop Res. 1998;16(5):618-21.