NCT00992927

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
1 year until next milestone

Results Posted

Study results publicly available

August 17, 2011

Completed
Last Updated

August 17, 2011

Status Verified

July 1, 2011

Enrollment Period

2.2 years

First QC Date

October 7, 2009

Results QC Date

August 15, 2010

Last Update Submit

July 21, 2011

Conditions

Adhesive Capsulitis

Keywords

Injections, Intra-ArticularRange of Motion, ArticularPain

Outcome Measures

Primary Outcomes (1)

  • Range of Motion (ROM) of the Glenohumeral Joint

    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

    1 month

Secondary Outcomes (1)

  • Pain Measured by Visual Analogue Scale (VAS)

    1 month

Study Arms (2)

CPIHD

EXPERIMENTAL

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

CRIHD

ACTIVE COMPARATOR

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

Interventions

Capsule-Preserving Intra-articular Hydraulic DistensionPROCEDURE

Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.

CPIHD
Capsule-Rupturing Intra-articular Hydraulic DistensionPROCEDURE

Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.

CRIHD

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (25)

  • 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.

    PMID: 14962967BACKGROUND

  • 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.

    PMID: 17179778BACKGROUND

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

    PMID: 11143905BACKGROUND

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

    PMID: 10738419BACKGROUND

  • 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.

    PMID: 9246090BACKGROUND

  • 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.

    PMID: 17673588BACKGROUND

  • 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.

    PMID: 16814141BACKGROUND

  • 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.

    PMID: 8186599BACKGROUND

  • 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.

    PMID: 16871412BACKGROUND

  • 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.

    PMID: 8024429BACKGROUND

  • 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.

    PMID: 14308098BACKGROUND

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

    PMID: 1516300BACKGROUND

  • 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.

    PMID: 8130999BACKGROUND

  • 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.

    PMID: 13680563BACKGROUND

  • 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.

    PMID: 18271012BACKGROUND

  • 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.

    PMID: 12632439BACKGROUND

  • 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.

    PMID: 1855018BACKGROUND

  • 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.

    PMID: 15213478BACKGROUND

  • 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.

    PMID: 4952729BACKGROUND

  • 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.

    PMID: 1611740BACKGROUND

  • 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.

    PMID: 11517365BACKGROUND

  • 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.

    PMID: 2592391BACKGROUND

  • 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.

    PMID: 8461078BACKGROUND

  • 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.

    PMID: 8986657BACKGROUND

  • Wiley AM. Arthroscopic appearance of frozen shoulder. Arthroscopy. 1991;7(2):138-43. doi: 10.1016/0749-8063(91)90098-i.

    PMID: 2069623BACKGROUND

MeSH Terms

Conditions

BursitisPain

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Sun Gun Chung/Professer
Organization
Seoul National University Hospital
suncg@snu.ac.kr
+82-2-2072-3954

Study Officials

  • Sun Gun Chung, MD, PhD

    Seoul National University College of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 7, 2009

First Posted

October 9, 2009

Study Start

March 1, 2008

Primary Completion

May 1, 2010

Study Completion

August 1, 2010

Last Updated

August 17, 2011

Results First Posted

August 17, 2011

Record last verified: 2011-07

Locations

KR(1)