Clinical trial NCT00992927: Should the Joint Capsule of the Painful Stiff Shoulder be Ruptured During Intra-articular Hydraulic Distension?
Official title: Comparative Study for the Efficacy of Capsule-Preserving Versus Capsule-Rupturing Intra-articular Hydraulic Distension in Patients With Painful Stiff Shoulders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adhesive Capsulitis
Keywords: Injections, Intra-Articular
Range of Motion, Articular
Pain
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2009-10-09
Enrollment: 54
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare the efficacy of intra-articular hydraulic distension (IHD) for the treatment of painful stiff shoulders between capsule-rupturing and capsule-preserving IHDs.

Detailed description: The Painful stiff shoulder (PSS), or the adhesive capsulitis, involves stiff and contracted joint capsule from fibrosis in the glenohumeral joint. Intra-articular hydraulic distension (IHD) enlarges the stiffened capsule by deforming it with excessive volume and pressure within the joint space. Although IHD is one of the most common treatment options for the PSS, the diversity of the IHD technique spans wide range. Specifically, it is not generally agreed as for which, between capsule-rupturing and capsule-preserving IHDs, is superior for PSS treatment. Capsule-preserving IHD might fail to infuse sufficient amount of fluid to avoid rupture, thus producing less satisfactory outcomes. However, we devised in our previous study a novel technique that enabled a physician to infuse the possible largest volume without rupturing the capsule. By employing the technique, we aim to compare the clinical efficacy of capsule-rupturing versus capsule-preserving IHDs in patients with PSSs.

Eligibility criteria: Inclusion Criteria:

* shoulder discomfort for at least one month
* limited range of motion of the glenohumeral joint in at least two directions

Exclusion Criteria:

* systemic inflammatory joint disease
* radiological evidence of bony abnormality of the shoulder
* full-thickness rotator cuff tear
* acute systemic medical illness
* history of major trauma or surgery involving the shoulder
* contraindication to intra-articular, local anesthestic injection

Primary outcomes:
measure: Range of Motion (ROM) of the Glenohumeral Joint
timeFrame: 1 month
Secondary outcomes:
measure: Pain Measured by Visual Analogue Scale (VAS)
timeFrame: 1 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University College of Medicine
name: Sun Gun Chung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 Mar;63(3):302-9. doi: 10.1136/ard.2002.004655.
citation: Uhthoff HK, Boileau P. Primary frozen shoulder: global capsular stiffness versus localized contracture. Clin Orthop Relat Res. 2007 Mar;456:79-84. doi: 10.1097/BLO.0b013e318030846d.
citation: Noel E, Thomas T, Schaeverbeke T, Thomas P, Bonjean M, Revel M. Frozen shoulder. Joint Bone Spine. 2000;67(5):393-400.
citation: Hannafin JA, Chiaia TA. Adhesive capsulitis. A treatment approach. Clin Orthop Relat Res. 2000 Mar;(372):95-109.
citation: Rodeo SA, Hannafin JA, Tom J, Warren RF, Wickiewicz TL. Immunolocalization of cytokines and their receptors in adhesive capsulitis of the shoulder. J Orthop Res. 1997 May;15(3):427-36. doi: 10.1002/jor.1100150316.
citation: Hand GC, Athanasou NA, Matthews T, Carr AJ. The pathology of frozen shoulder. J Bone Joint Surg Br. 2007 Jul;89(7):928-32. doi: 10.1302/0301-620X.89B7.19097.
citation: Amoretti N, Grimaud A, Brocq O, Roux C, Dausse F, Fournol M, Chevallier P, Bruneton JN. Shoulder distension arthrography in adhesive capsulitis. Clin Imaging. 2006 Jul-Aug;30(4):254-6. doi: 10.1016/j.clinimag.2006.01.022.
citation: Gavant ML, Rizk TE, Gold RE, Flick PA. Distention arthrography in the treatment of adhesive capsulitis of the shoulder. J Vasc Interv Radiol. 1994 Mar-Apr;5(2):305-8. doi: 10.1016/s1051-0443(94)71488-3.
citation: Ibrahim T, Rahbi H, Beiri A, Jeyapalan K, Taylor GJ. Adhesive capsulitis of the shoulder: the rate of manipulation following distension arthrogram. Rheumatol Int. 2006 Nov;27(1):7-9. doi: 10.1007/s00296-006-0160-1. Epub 2006 Jul 27.
citation: Rizk TE, Gavant ML, Pinals RS. Treatment of adhesive capsulitis (frozen shoulder) with arthrographic capsular distension and rupture. Arch Phys Med Rehabil. 1994 Jul;75(7):803-7.
citation: ANDREN L, LUNDBERG BJ. TREATMENT OF RIGID SHOULDERS BY JOINT DISTENSION DURING ARTHROGRAPHY. Acta Orthop Scand. 1965;36:45-53. doi: 10.3109/17453676508989370. No abstract available.
citation: Ekelund AL, Rydell N. Combination treatment for adhesive capsulitis of the shoulder. Clin Orthop Relat Res. 1992 Sep;(282):105-9.
citation: Mulcahy KA, Baxter AD, Oni OO, Finlay D. The value of shoulder distension arthrography with intraarticular injection of steroid and local anaesthetic: a follow-up study. Br J Radiol. 1994 Mar;67(795):263-6. doi: 10.1259/0007-1285-67-795-263.
citation: Vad VB, Sakalkale D, Warren RF. The role of capsular distention in adhesive capsulitis. Arch Phys Med Rehabil. 2003 Sep;84(9):1290-2. doi: 10.1016/s0003-9993(03)00261-2.
citation: Lee KJ, Lee HD, Chung SG. Real-time pressure monitoring of intraarticular hydraulic distension for painful stiff shoulders. J Orthop Res. 2008 Jul;26(7):965-70. doi: 10.1002/jor.20535.
citation: Carette S, Moffet H, Tardif J, Bessette L, Morin F, Fremont P, Bykerk V, Thorne C, Bell M, Bensen W, Blanchette C. 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 Mar;48(3):829-38. doi: 10.1002/art.10954.
citation: 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 Jun 22;302(6791):1498-501. doi: 10.1136/bmj.302.6791.1498.
citation: 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 Jul;83(7):537-46; quiz 547-9. doi: 10.1097/01.phm.0000130030.73449.60.
citation: Lundberg BJ. The frozen shoulder. Clinical and radiographical observations. The effect of manipulation under general anesthesia. Structure and glycosaminoglycan content of the joint capsule. Local bone metabolism. Acta Orthop Scand Suppl. 1969;119:1-59. No abstract available.
citation: Neer CS 2nd, Satterlee CC, Dalsey RM, Flatow EL. The anatomy and potential effects of contracture of the coracohumeral ligament. Clin Orthop Relat Res. 1992 Jul;(280):182-5.
citation: Omari A, Bunker TD. Open surgical release for frozen shoulder: surgical findings and results of the release. J Shoulder Elbow Surg. 2001 Jul-Aug;10(4):353-7. doi: 10.1067/mse.2001.115986.
citation: Ozaki J, Nakagawa Y, Sakurai G, Tamai S. Recalcitrant chronic adhesive capsulitis of the shoulder. Role of contracture of the coracohumeral ligament and rotator interval in pathogenesis and treatment. J Bone Joint Surg Am. 1989 Dec;71(10):1511-5.
citation: Uitvlugt G, Detrisac DA, Johnson LL, Austin MD, Johnson C. Arthroscopic observations before and after manipulation of frozen shoulder. Arthroscopy. 1993;9(2):181-5. doi: 10.1016/s0749-8063(05)80371-8.
citation: Warner JJ, Allen A, Marks PH, Wong P. Arthroscopic release for chronic, refractory adhesive capsulitis of the shoulder. J Bone Joint Surg Am. 1996 Dec;78(12):1808-16. doi: 10.2106/00004623-199612000-00003.
citation: Wiley AM. Arthroscopic appearance of frozen shoulder. Arthroscopy. 1991;7(2):138-43. doi: 10.1016/0749-8063(91)90098-i.