Should the Joint Capsule of the Painful Stiff Shoulder be Ruptured During Intra-articular Hydraulic Distension? - Full Text View

Purpose

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.

Condition	Intervention
Adhesive Capsulitis	Procedure: Capsule-Preserving Intra-articular Hydraulic Distension Procedure: Capsule-Rupturing Intra-articular Hydraulic Distension

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Comparative Study for the Efficacy of Capsule-Preserving Versus Capsule-Rupturing Intra-articular Hydraulic Distension in Patients With Painful Stiff Shoulders

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:

Range of Motion (ROM) of the Glenohumeral Joint [ Time Frame: 1 month ] [ Designated as safety issue: No ]
1. before intervention for all participants
2. using a goniometer
3. patient sitting on a stool with the arm at anatomical position
4. worst: 0 degree
5. best: 360 degree

Secondary Outcome Measures:

Pain Measured by Visual Analogue Scale (VAS) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
1. before intervention for all participants
2. using 10cm horizontal visual analog scale
3. best: 0cm (no pain)
4. worst: 10cm (worst pain)

Enrollment:	54
Study Start Date:	March 2008
Study Completion Date:	August 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: CPIHD Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.	Procedure: Capsule-Preserving Intra-articular Hydraulic Distension Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.
Active Comparator: CRIHD Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.	Procedure: Capsule-Rupturing Intra-articular Hydraulic Distension Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.

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

Ages Eligible for Study:	20 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00992927

Locations

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Principal Investigator:

Sun Gun Chung, MD, PhD

Seoul National University College of Medicine

More Information

Publications:

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.

Uhthoff HK, Boileau P. Primary frozen shoulder: global capsular stiffness versus localized contracture. Clin Orthop Relat Res. 2007 Mar;456:79-84.

Noël E, Thomas T, Schaeverbeke T, Thomas P, Bonjean M, Revel M. Frozen shoulder. Joint Bone Spine. 2000;67(5):393-400. Review.

Hannafin JA, Chiaia TA. Adhesive capsulitis. A treatment approach. Clin Orthop Relat Res. 2000 Mar;(372):95-109. Review.

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.

Hand GC, Athanasou NA, Matthews T, Carr AJ. The pathology of frozen shoulder. J Bone Joint Surg Br. 2007 Jul;89(7):928-32.

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.

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.

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. Epub 2006 Jul 27.

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.

ANDREN L, LUNDBERG BJ. TREATMENT OF RIGID SHOULDERS BY JOINT DISTENSION DURING ARTHROGRAPHY. Acta Orthop Scand. 1965;36:45-53. No abstract available.

Ekelund AL, Rydell N. Combination treatment for adhesive capsulitis of the shoulder. Clin Orthop Relat Res. 1992 Sep;(282):105-9.

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.

Vad VB, Sakalkale D, Warren RF. The role of capsular distention in adhesive capsulitis. Arch Phys Med Rehabil. 2003 Sep;84(9):1290-2.

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.

Carette S, Moffet H, Tardif J, Bessette L, Morin F, Frémont 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.

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.

Piotte F, Gravel D, Moffet H, Fliszar E, Roy A, Nadeau S, Bédard 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.

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. Review. No abstract available.

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.

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.

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.

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.

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.

Wiley AM. Arthroscopic appearance of frozen shoulder. Arthroscopy. 1991;7(2):138-43.

Responsible Party:	Sun Gun Chung/Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT00992927 History of Changes
Other Study ID Numbers:	SNUH-RM-SGChung-IHD-01
Study First Received:	October 7, 2009
Results First Received:	August 15, 2010
Last Updated:	July 21, 2011
Health Authority:	Korea: Food and Drug Administration Korea: Ministry for Health, Welfare and Family Affairs

Keywords provided by Seoul National University Hospital:

Injections, Intra-Articular
Range of Motion, Articular
Pain

Additional relevant MeSH terms:

Bursitis
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 22, 2013