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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

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 August 20, 2014