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

Adhesive Capsulitis Clinical Trial

Official title:

Comparative Study for the Efficacy of Capsule-Preserving Versus Capsule-Rupturing Intra-articular Hydraulic Distension in Patients With Painful Stiff Shoulders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00992927
• Other study ID #: SNUH-RM-SGChung-IHD-01
• Status: Completed
• Phase: N/A
• First received: October 7, 2009
• Last updated: July 21, 2011
• Start date: March 2008
• Est. completion date: August 2010

Study information

• Verified date: July 2011
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug AdministrationKorea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: August 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adhesive Capsulitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (25)

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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. — View Citation

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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. — View Citation

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Range of Motion (ROM) of the Glenohumeral Joint	before intervention for all participants; using a goniometer; patient sitting on a stool with the arm at anatomical position; worst: 0 degree; best: 360 degree	1 month	No
Secondary	Pain Measured by Visual Analogue Scale (VAS)	before intervention for all participants; using 10cm horizontal visual analog scale; best: 0cm (no pain); worst: 10cm (worst pain)	1 month	No