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

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ClinicalTrials.gov Identifier: NCT00992927
Recruitment Status : Completed
First Posted : October 9, 2009
Results First Posted : August 17, 2011
Last Update Posted : August 17, 2011
Sponsor:
Information provided by:
Seoul National University Hospital

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Adhesive Capsulitis
Interventions Procedure: Capsule-Preserving Intra-articular Hydraulic Distension
Procedure: Capsule-Rupturing Intra-articular Hydraulic Distension
Enrollment 54
Recruitment Details 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 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.
Arm/Group Title CPIHD CRIHD
Hide Arm/Group Description 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 (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.
Period Title: Overall Study
Started 32 22
Completed 32 22
Not Completed 0 0
Arm/Group Title CPIHD CRIHD Total
Hide Arm/Group Description 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 (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed. Total of all reporting groups
Overall Number of Baseline Participants 32 22 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 22 participants 54 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
21
  65.6%
18
  81.8%
39
  72.2%
>=65 years
11
  34.4%
4
  18.2%
15
  27.8%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 22 participants 54 participants
61.09  (10.621) 56.55  (9.521) 59.24  (10.343)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 22 participants 54 participants
Female
21
  65.6%
16
  72.7%
37
  68.5%
Male
11
  34.4%
6
  27.3%
17
  31.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 32 participants 22 participants 54 participants
32 22 54
Pain Measured by Visual Analogue Scale (VAS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 32 participants 22 participants 54 participants
6.87  (3.01) 7.17  (2.09) 6.99  (2.65)
[1]
Measure Description:
  1. before intervention for all participants
  2. using 10cm horizontal visual analog scale
  3. best: 0cm (no pain)
  4. worst: 10cm (worst pain)
Range of Motion (ROM) of the Glenohumeral Joint   [1] 
Mean (Standard Deviation)
Unit of measure:  Degree
Number Analyzed 32 participants 22 participants 54 participants
223.56  (42.111) 203.05  (46.163) 215.20  (44.555)
[1]
Measure Description:
  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.Primary Outcome
Title Range of Motion (ROM) of the Glenohumeral Joint
Hide Description
  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
Time Frame 1 month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CPIHD CRIHD
Hide Arm/Group Description:
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 (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.
Overall Number of Participants Analyzed 32 22
Mean (Standard Deviation)
Unit of Measure: degree
261.95  (47.197) 241.84  (57.304)
2.Secondary Outcome
Title Pain Measured by Visual Analogue Scale (VAS)
Hide Description
  1. before intervention for all participants
  2. using 10cm horizontal visual analog scale
  3. best: 0cm (no pain)
  4. worst: 10cm (worst pain)
Time Frame 1 month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CPIHD CRIHD
Hide Arm/Group Description:
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 (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.
Overall Number of Participants Analyzed 32 22
Mean (Standard Deviation)
Unit of Measure: cm
2.96  (2.89) 5.03  (2.95)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CPIHD CRIHD
Hide Arm/Group Description 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 (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.
All-Cause Mortality
CPIHD CRIHD
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
CPIHD CRIHD
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/22 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CPIHD CRIHD
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/22 (0.00%) 
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
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
First Submitted: October 7, 2009
First Posted: October 9, 2009
Results First Submitted: August 15, 2010
Results First Posted: August 17, 2011
Last Update Posted: August 17, 2011