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

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00992927
First received: October 7, 2009
Last updated: July 21, 2011
Last verified: July 2011

October 7, 2009
July 21, 2011
March 2008
May 2010   (final data collection date for primary outcome measure)
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
Range of motion (ROM) of the glenohumeral joint [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00992927 on ClinicalTrials.gov Archive Site
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)
Pain measured by Visual Analogue Scale (VAS) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Should the Joint Capsule of the Painful Stiff Shoulder be Ruptured During Intra-articular Hydraulic Distension?
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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Adhesive Capsulitis
  • 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.
  • 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.
  • Experimental: CPIHD
    Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.
    Intervention: Procedure: Capsule-Preserving Intra-articular Hydraulic Distension
  • Active Comparator: CRIHD
    Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.
    Intervention: Procedure: Capsule-Rupturing Intra-articular Hydraulic Distension

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
August 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
20 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00992927
SNUH-RM-SGChung-IHD-01
No
Sun Gun Chung/Professor, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Principal Investigator: Sun Gun Chung, MD, PhD Seoul National University College of Medicine
Seoul National University Hospital
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP