drugset / Trial / NCT05327972
DEgenerative ROtator Cuff Disease and Botulinum TOXin
Phase 2
Recruiting
60 enrolled
Assistance Publique - Hôpitaux de Paris
Merz Pharmaceuticals GmbH · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The aim of the study is to assess the effectiveness of botulinum toxin in persistent shoulder pain due to degenerative rotator cuff disease.
Timeline
- Start
- 2023-01-20
- Primary completion
- 2027-02
- Completion
- 2027-02
Publications
- Background Badley EM, Tennant A. Changing profile of joint disorders with age: findings from a postal survey of the population of Calderdale, West Yorkshire, United Kingdom. Ann Rheum Dis. 1992 Mar;51(3):366-71. doi: 10.1136/ard.51.3.366.
- Background van der Heijden GJ. Shoulder disorders: a state-of-the-art review. Baillieres Best Pract Res Clin Rheumatol. 1999 Jun;13(2):287-309. doi: 10.1053/berh.1999.0021.
- Background Luime JJ, Koes BW, Hendriksen IJ, Burdorf A, Verhagen AP, Miedema HS, Verhaar JA. Prevalence and incidence of shoulder pain in the general population; a systematic review. Scand J Rheumatol. 2004;33(2):73-81. doi: 10.1080/03009740310004667.
- Background Bot SD, van der Waal JM, Terwee CB, van der Windt DA, Schellevis FG, Bouter LM, Dekker J. Incidence and prevalence of complaints of the neck and upper extremity in general practice. Ann Rheum Dis. 2005 Jan;64(1):118-23. doi: 10.1136/ard.2003.019349.
- Background Linsell L, Dawson J, Zondervan K, Rose P, Randall T, Fitzpatrick R, Carr A. Prevalence and incidence of adults consulting for shoulder conditions in UK primary care; patterns of diagnosis and referral. Rheumatology (Oxford). 2006 Feb;45(2):215-21. doi: 10.1093/rheumatology/kei139. Epub 2005 Nov 1.
- Background Hartvigsen J, Davidsen M, Hestbaek L, Sogaard K, Roos EM. Patterns of musculoskeletal pain in the population: a latent class analysis using a nationally representative interviewer-based survey of 4817 Danes. Eur J Pain. 2013 Mar;17(3):452-60. doi: 10.1002/j.1532-2149.2012.00225.x. Epub 2012 Oct 5.
- Background Peters D, Davies P, Pietroni P. Musculoskeletal clinic in general practice: study of one year's referrals. Br J Gen Pract. 1994 Jan;44(378):25-9.
- Background van der Windt DA, Koes BW, de Jong BA, Bouter LM. Shoulder disorders in general practice: incidence, patient characteristics, and management. Ann Rheum Dis. 1995 Dec;54(12):959-64. doi: 10.1136/ard.54.12.959.
- Background Vecchio P, Kavanagh R, Hazleman BL, King RH. Shoulder pain in a community-based rheumatology clinic. Br J Rheumatol. 1995 May;34(5):440-2. doi: 10.1093/rheumatology/34.5.440.
- Background Gartsman GM, Brinker MR, Khan M, Karahan M. Self-assessment of general health status in patients with five common shoulder conditions. J Shoulder Elbow Surg. 1998 May-Jun;7(3):228-37. doi: 10.1016/s1058-2746(98)90050-7.
- Background Ostor AJ, Richards CA, Prevost AT, Speed CA, Hazleman BL. Diagnosis and relation to general health of shoulder disorders presenting to primary care. Rheumatology (Oxford). 2005 Jun;44(6):800-5. doi: 10.1093/rheumatology/keh598. Epub 2005 Mar 15.
- Background Tekavec E, Joud A, Rittner R, Mikoczy Z, Nordander C, Petersson IF, Englund M. Population-based consultation patterns in patients with shoulder pain diagnoses. BMC Musculoskelet Disord. 2012 Nov 29;13:238. doi: 10.1186/1471-2474-13-238.
- Background Virta L, Joranger P, Brox JI, Eriksson R. Costs of shoulder pain and resource use in primary health care: a cost-of-illness study in Sweden. BMC Musculoskelet Disord. 2012 Feb 10;13:17. doi: 10.1186/1471-2474-13-17.
- Background Roquelaure Y, Ha C, Leclerc A, Touranchet A, Sauteron M, Melchior M, Imbernon E, Goldberg M. Epidemiologic surveillance of upper-extremity musculoskeletal disorders in the working population. Arthritis Rheum. 2006 Oct 15;55(5):765-78. doi: 10.1002/art.22222.
- Background Wilson d'Almeida K, Godard C, Leclerc A, Lahon G. Sickness absence for upper limb disorders in a French company. Occup Med (Lond). 2008 Oct;58(7):506-8. doi: 10.1093/occmed/kqn084. Epub 2008 Jun 27.
- Background Benson RT, McDonnell SM, Knowles HJ, Rees JL, Carr AJ, Hulley PA. Tendinopathy and tears of the rotator cuff are associated with hypoxia and apoptosis. J Bone Joint Surg Br. 2010 Mar;92(3):448-53. doi: 10.1302/0301-620X.92B3.23074.
- Background Millar NL, Reilly JH, Kerr SC, Campbell AL, Little KJ, Leach WJ, Rooney BP, Murrell GA, McInnes IB. Hypoxia: a critical regulator of early human tendinopathy. Ann Rheum Dis. 2012 Feb;71(2):302-10. doi: 10.1136/ard.2011.154229. Epub 2011 Oct 4.
- Background Yamaguchi K, Tetro AM, Blam O, Evanoff BA, Teefey SA, Middleton WD. Natural history of asymptomatic rotator cuff tears: a longitudinal analysis of asymptomatic tears detected sonographically. J Shoulder Elbow Surg. 2001 May-Jun;10(3):199-203. doi: 10.1067/mse.2001.113086.
- Background Beaudreuil J, Dhenain M, Coudane H, Mlika-Cabanne N. Clinical practice guidelines for the surgical management of rotator cuff tears in adults. Orthop Traumatol Surg Res. 2010 Apr;96(2):175-9. doi: 10.1016/j.otsr.2010.02.002.
- Background Page MJ, Green S, McBain B, Surace SJ, Deitch J, Lyttle N, Mrocki MA, Buchbinder R. Manual therapy and exercise for rotator cuff disease. Cochrane Database Syst Rev. 2016 Jun 10;2016(6):CD012224. doi: 10.1002/14651858.CD012224.
- Background Placzek R, Drescher W, Deuretzbacher G, Hempfing A, Meiss AL. Treatment of chronic radial epicondylitis with botulinum toxin A. A double-blind, placebo-controlled, randomized multicenter study. J Bone Joint Surg Am. 2007 Feb;89(2):255-60. doi: 10.2106/JBJS.F.00401.
- Background Wuelker N, Schmotzer H, Thren K, Korell M. Translation of the glenohumeral joint with simulated active elevation. Clin Orthop Relat Res. 1994 Dec;(309):193-200.
- Background Collin P, Matsumura N, Ladermann A, Denard PJ, Walch G. Relationship between massive chronic rotator cuff tear pattern and loss of active shoulder range of motion. J Shoulder Elbow Surg. 2014 Aug;23(8):1195-202. doi: 10.1016/j.jse.2013.11.019. Epub 2014 Jan 14.
- Background Roach KE, Budiman-Mak E, Songsiridej N, Lertratanakul Y. Development of a shoulder pain and disability index. Arthritis Care Res. 1991 Dec;4(4):143-9.
- Background Jobe FW, Moynes DR. Delineation of diagnostic criteria and a rehabilitation program for rotator cuff injuries. Am J Sports Med. 1982 Nov-Dec;10(6):336-9. doi: 10.1177/036354658201000602.
- Background Angst F, Schwyzer HK, Aeschlimann A, Simmen BR, Goldhahn J. Measures of adult shoulder function: Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH) and its short version (QuickDASH), Shoulder Pain and Disability Index (SPADI), American Shoulder and Elbow Surgeons (ASES) Society standardized shoulder assessment form, Constant (Murley) Score (CS), Simple Shoulder Test (SST), Oxford Shoulder Score (OSS), Shoulder Disability Questionnaire (SDQ), and Western Ontario Shoulder Instability Index (WOSI). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S174-88. doi: 10.1002/acr.20630. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 100 iu | Intramuscular |