Should the Joint Capsule of the Painful Stiff Shoulder be Ruptured During Intra-articular Hydraulic Distension?
Primary Purpose
Adhesive Capsulitis
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Capsule-Preserving Intra-articular Hydraulic Distension
Capsule-Rupturing Intra-articular Hydraulic Distension
Sponsored by
About this trial
This is an interventional treatment trial for Adhesive Capsulitis focused on measuring Injections, Intra-Articular, Range of Motion, Articular, Pain
Eligibility 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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CPIHD
CRIHD
Arm 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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT00992927
First Posted
October 7, 2009
Last Updated
July 21, 2011
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00992927
Brief Title
Should the Joint Capsule of the Painful Stiff Shoulder be Ruptured During Intra-articular Hydraulic Distension?
Official Title
Comparative Study for the Efficacy of Capsule-Preserving Versus Capsule-Rupturing Intra-articular Hydraulic Distension in Patients With Painful Stiff Shoulders
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis
Keywords
Injections, Intra-Articular, Range of Motion, Articular, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CPIHD
Arm Type
Experimental
Arm Description
Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.
Arm Title
CRIHD
Arm Type
Active Comparator
Arm Description
Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.
Intervention Type
Procedure
Intervention Name(s)
Capsule-Preserving Intra-articular Hydraulic Distension
Intervention Description
Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.
Intervention Type
Procedure
Intervention Name(s)
Capsule-Rupturing Intra-articular Hydraulic Distension
Intervention Description
Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.
Primary Outcome Measure Information:
Title
Range of Motion (ROM) of the Glenohumeral Joint
Description
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
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Pain Measured by Visual Analogue Scale (VAS)
Description
before intervention for all participants
using 10cm horizontal visual analog scale
best: 0cm (no pain)
worst: 10cm (worst pain)
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sun Gun Chung, MD, PhD
Organizational Affiliation
Seoul National University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
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Should the Joint Capsule of the Painful Stiff Shoulder be Ruptured During Intra-articular Hydraulic Distension?
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