Should the Joint Capsule of the Painful Stiff Shoulder be Ruptured During Intra-articular Hydraulic Distension?
July 21, 2011 updated by: Seoul National University Hospital
Comparative Study for the Efficacy of Capsule-Preserving Versus Capsule-Rupturing Intra-articular Hydraulic Distension in Patients With Painful Stiff Shoulders
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Seoul, Korea, Republic of
- Seoul National University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CPIHD
Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.
|
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.
|
Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range of Motion (ROM) of the Glenohumeral Joint
Time Frame: 1 month
|
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Measured by Visual Analogue Scale (VAS)
Time Frame: 1 month
|
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- Noel E, Thomas T, Schaeverbeke T, Thomas P, Bonjean M, Revel M. Frozen shoulder. Joint Bone Spine. 2000;67(5):393-400.
- Hannafin JA, Chiaia TA. Adhesive capsulitis. A treatment approach. Clin Orthop Relat Res. 2000 Mar;(372):95-109.
- 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.
- 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.
- 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.
- 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.
- 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. doi: 10.3109/17453676508989370. 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. doi: 10.1259/0007-1285-67-795-263.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. doi: 10.1067/mse.2001.115986.
- 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. doi: 10.1016/s0749-8063(05)80371-8.
- 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.
- Wiley AM. Arthroscopic appearance of frozen shoulder. Arthroscopy. 1991;7(2):138-43. doi: 10.1016/0749-8063(91)90098-i.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
October 7, 2009
First Submitted That Met QC Criteria
October 8, 2009
First Posted (Estimate)
October 9, 2009
Study Record Updates
Last Update Posted (Estimate)
August 17, 2011
Last Update Submitted That Met QC Criteria
July 21, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SNUH-RM-SGChung-IHD-01
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