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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
Results First Received: August 15, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Adhesive Capsulitis
Interventions: Procedure: Capsule-Preserving Intra-articular Hydraulic Distension
Procedure: Capsule-Rupturing Intra-articular Hydraulic Distension

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Dates: from Mar 2008 until Oct 2009 Type of Location: outpatient clinic at a university hospital Method of Recruitment: informed consent from eligible patients

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with other diagnoses than the painful stiff shoulder, such as full-thickness rotator cuff tear, osteoarthritis and others, were excluded from the trial when the final diagnosis was determined.

Reporting Groups
  Description
CPIHD Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.
CRIHD Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.

Participant Flow:   Overall Study
    CPIHD     CRIHD  
STARTED     32     22  
COMPLETED     32     22  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
CPIHD Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.
CRIHD Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.
Total Total of all reporting groups

Baseline Measures
    CPIHD     CRIHD     Total  
Number of Participants  
[units: participants]
  32     22     54  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     21     18     39  
>=65 years     11     4     15  
Age  
[units: years]
Mean ± Standard Deviation
  61.09  ± 10.621     56.55  ± 9.521     59.24  ± 10.343  
Gender  
[units: participants]
     
Female     21     16     37  
Male     11     6     17  
Region of Enrollment  
[units: participants]
     
Korea, Republic of     32     22     54  
Pain Measured by Visual Analogue Scale (VAS) [1]
[units: cm]
Mean ± Standard Deviation
  6.87  ± 3.01     7.17  ± 2.09     6.99  ± 2.65  
Range of Motion (ROM) of the Glenohumeral Joint [2]
[units: degree]
Mean ± Standard Deviation
  223.56  ± 42.111     203.05  ± 46.163     215.20  ± 44.555  
[1]
  1. before intervention for all participants
  2. using 10cm horizontal visual analog scale
  3. best: 0cm (no pain)
  4. worst: 10cm (worst pain)
[2]
  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



  Outcome Measures
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1.  Primary:   Range of Motion (ROM) of the Glenohumeral Joint   [ Time Frame: 1 month ]

2.  Secondary:   Pain Measured by Visual Analogue Scale (VAS)   [ Time Frame: 1 month ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Sun Gun Chung/Professer
Organization: Seoul National University Hospital
phone: +82-2-2072-3954
e-mail: suncg@snu.ac.kr


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 and Welfare