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Corticosteroids and / or Arthrographic Distention in the Treatment of Adhesive Capsulitis (CADAC)

Primary Purpose

Adhesive Capsulitis, Frozen Shoulder

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Arthrographic distention
Intra-articular corticosteroid Depo Medrol
Sponsored by
Imelda Hospital, Bonheiden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Capsulitis focused on measuring Arthrographic distention, Hydrodilatation, Intra-articular corticosteroid injection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pain and stiffness in predominantly 1 shoulder for 4 weeks or longer
  • Restriction of passive motion of greater than 30° in 2 or more planes of movement (measured to onset of pain with goniometer)

Exclusion Criteria:

  • Previous arthrographic distention and/or corticosteroid injection
  • Systemic inflammatory joint disease
  • Radiological evidence of osteoarthritis of the shoulder or fracture
  • Signs of a complete rotator cuff tear
  • Contraindications to arthrogram and/or distention
  • Lack of written informed consent

Sites / Locations

  • Imelda Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Arthrographic distention + intra-articular corticosteroid

Arthrographic distention

Intra-articular corticosteroid

Arm Description

Arthrographic distention of the glenohumeral joint with injection of 5 ml contrast, 1 ml (40 mg) Depo Medrol(Methylprednisolone Acetate Injectable Suspension), 15 ml local anaesthetic (Prilocaine) and up to 15 ml saline.

Arthrographic distention of the glenohumeral joint with injection of 5 ml contrast, 15 ml local anaesthetic (Prilocaine) and up to 15 ml saline.

Arthrographic pseudodistention of the glenohumeral joint with injection of 5 ml contrast and 1 ml (40 mg) Depo Medrol(Methylprednisolone Acetate Injectable Suspension).

Outcomes

Primary Outcome Measures

Shoulder pain and disability index(SPADI)

Secondary Outcome Measures

Shoulder pain and disability index (SPADI)
Overall pain score
Universal pain scale
Range of motion
Total shoulder abduction (in degrees, measured with goniometer) External rotation in neutral position (in degrees, measured with goniometer) Hand behind back (highest reachable anatomical landmark)

Full Information

First Posted
November 7, 2013
Last Updated
November 13, 2013
Sponsor
Imelda Hospital, Bonheiden
Collaborators
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT01983527
Brief Title
Corticosteroids and / or Arthrographic Distention in the Treatment of Adhesive Capsulitis
Acronym
CADAC
Official Title
A Prospective Randomized 3-arm Trial Comparing Intra-articular Corticosteroid Injection vs Arthrographic Distention vs Arthrographic Distention Plus Intra-articular Corticosteroid Injection in the Treatment of Adhesive Capsulitis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
November 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Imelda Hospital, Bonheiden
Collaborators
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Arthrographic distention of the shoulder joint is an increasingly popular treatment option in the management of patients with frozen shoulder. Most have included the intra-articular injection of a corticosteroid as part of the procedure, but it is not known if this is necessary. It is also not known whether arthrographic distention using steroid and saline is better than intra-articular steroid injection alone. The purpose of this study is to determine whether there is an additional benefit in the combination of arthrographic distention plus intra-articular corticosteroid injection compared to arthrographic distention or intra-articular corticosteroid injection alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis, Frozen Shoulder
Keywords
Arthrographic distention, Hydrodilatation, Intra-articular corticosteroid injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arthrographic distention + intra-articular corticosteroid
Arm Type
Experimental
Arm Description
Arthrographic distention of the glenohumeral joint with injection of 5 ml contrast, 1 ml (40 mg) Depo Medrol(Methylprednisolone Acetate Injectable Suspension), 15 ml local anaesthetic (Prilocaine) and up to 15 ml saline.
Arm Title
Arthrographic distention
Arm Type
Active Comparator
Arm Description
Arthrographic distention of the glenohumeral joint with injection of 5 ml contrast, 15 ml local anaesthetic (Prilocaine) and up to 15 ml saline.
Arm Title
Intra-articular corticosteroid
Arm Type
Active Comparator
Arm Description
Arthrographic pseudodistention of the glenohumeral joint with injection of 5 ml contrast and 1 ml (40 mg) Depo Medrol(Methylprednisolone Acetate Injectable Suspension).
Intervention Type
Procedure
Intervention Name(s)
Arthrographic distention
Other Intervention Name(s)
Hydrodilatation
Intervention Description
Arthrographic distention of the glenohumeral joint with injection of 5 ml contrast, 15 ml local anaesthetic (Prilocaine) and up to 15 ml saline.
Intervention Type
Drug
Intervention Name(s)
Intra-articular corticosteroid Depo Medrol
Intervention Description
Intra-articular injection of 1 ml (40 mg) Depo Medrol(Methylprednisolone Acetate Injectable Suspension)
Primary Outcome Measure Information:
Title
Shoulder pain and disability index(SPADI)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Shoulder pain and disability index (SPADI)
Time Frame
weekly for a period of 3 months plus at follow-up (4 months and 12 months)
Title
Overall pain score
Description
Universal pain scale
Time Frame
weekly for a period of 3 months, plus at follow-up (4 months and 12 months)
Title
Range of motion
Description
Total shoulder abduction (in degrees, measured with goniometer) External rotation in neutral position (in degrees, measured with goniometer) Hand behind back (highest reachable anatomical landmark)
Time Frame
4 weeks, 4 months and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pain and stiffness in predominantly 1 shoulder for 4 weeks or longer Restriction of passive motion of greater than 30° in 2 or more planes of movement (measured to onset of pain with goniometer) Exclusion Criteria: Previous arthrographic distention and/or corticosteroid injection Systemic inflammatory joint disease Radiological evidence of osteoarthritis of the shoulder or fracture Signs of a complete rotator cuff tear Contraindications to arthrogram and/or distention Lack of written informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rolf Symons, MD
Phone
+32(0)15/50.62.31
Email
rolf.symons@imelda.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rolf Symons, MD
Organizational Affiliation
Imeldaziekenhuis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imelda Hospital
City
Bonheiden
State/Province
Antwerpen
ZIP/Postal Code
2820
Country
Belgium
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rolf Symons, MD
Phone
+32(0)15/50.62.31
Email
rolf.symons@imelda.be
First Name & Middle Initial & Last Name & Degree
Symons Rolf, MD
First Name & Middle Initial & Last Name & Degree
Demeyere Annick, MD
First Name & Middle Initial & Last Name & Degree
Vankan Yoeri, MD
First Name & Middle Initial & Last Name & Degree
Perdieus Dirk, MD
First Name & Middle Initial & Last Name & Degree
Van Raebroeckx Antoon, MD
First Name & Middle Initial & Last Name & Degree
Ruette Peter, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
1855018
Citation
Jacobs LG, Barton MA, Wallace WA, Ferrousis J, Dunn NA, Bossingham DH. Intra-articular distension and steroids in the management of capsulitis of the shoulder. BMJ. 1991 Jun 22;302(6791):1498-501. doi: 10.1136/bmj.302.6791.1498.
Results Reference
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PubMed Identifier
1562888
Citation
Corbeil V, Dussault RG, Leduc BE, Fleury J. [Adhesive capsulitis of the shoulder: a comparative study of arthrography with intra-articular corticotherapy and with or without capsular distension]. Can Assoc Radiol J. 1992 Apr;43(2):127-30. French.
Results Reference
background
PubMed Identifier
9855212
Citation
Gam AN, Schydlowsky P, Rossel I, Remvig L, Jensen EM. Treatment of "frozen shoulder" with distension and glucorticoid compared with glucorticoid alone. A randomised controlled trial. Scand J Rheumatol. 1998;27(6):425-30. doi: 10.1080/030097498442244.
Results Reference
background
PubMed Identifier
14962967
Citation
Buchbinder R, Green S, Forbes A, Hall S, Lawler G. Arthrographic joint distension with saline and steroid improves function and reduces pain in patients with painful stiff shoulder: results of a randomised, double blind, placebo controlled trial. Ann Rheum Dis. 2004 Mar;63(3):302-9. doi: 10.1136/ard.2002.004655.
Results Reference
background
PubMed Identifier
15695959
Citation
Khan AA, Mowla A, Shakoor MA, Rahman MR. Arthrographic distension of the shoulder joint in the management of frozen shoulder. Mymensingh Med J. 2005 Jan;14(1):67-70.
Results Reference
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Corticosteroids and / or Arthrographic Distention in the Treatment of Adhesive Capsulitis

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