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Surgery or Capsular Distention With Steroid in the Treatment of Primary Frozen Shoulder?

Primary Purpose

Adhesive Capsulitis

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Arthroscopic capsular release
Distention with steroid
Sponsored by
Bergen Surgical Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Capsulitis focused on measuring Randomized study capsulotomy vs distention with steroid

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. The patient must have understood all information about the project and must have signed the informed consent letter about participation in the study including rehabilitation and follow-up

  2. The patients must have a history and clinical findings typical for primary frozen shoulder with globally reduced range of motion in the shoulder.

    • External rotation 20 degrees or less
    • Abduction 45 degrees or less
  3. The patients must not be in phase 1 (inflammation phase)
  4. Diabetics may be included
  5. MRI must be taken to exclude other reasons for stiffness

Exclusion Criteria:

  1. Other reasons for stiffness( cuff rupture, arthritis)
  2. Posttraumatic or postoperative stiffness
  3. Patients not suited for day surgery
  4. Patients with a history of subacromial impingement before developing stiffness

Sites / Locations

  • Haraldsplass Deaconess HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Arthroscopic Capsulotomy

Distention with steroid

Arm Description

Arthroscopic capsular release

Arthrographic distention with contrast, saline, steroid and local anaesthetic

Outcomes

Primary Outcome Measures

Shoulder Function

Secondary Outcome Measures

Shoulder range of motion

Full Information

First Posted
December 9, 2009
Last Updated
December 15, 2009
Sponsor
Bergen Surgical Hospital
Collaborators
Haraldsplass Deaconess Hospital, Haukeland University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01029600
Brief Title
Surgery or Capsular Distention With Steroid in the Treatment of Primary Frozen Shoulder?
Official Title
Arthroscopic Capsulotomy vs Arthrographic Distention With Steroid in the Treatment of Primary Frozen Shoulder. A Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
April 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Bergen Surgical Hospital
Collaborators
Haraldsplass Deaconess Hospital, Haukeland University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to compare two different treatment regimens for primary frozen shoulder: Arthroscopic capsulotomy and arthrographic distention with steroid.
Detailed Description
Patients with primary frozen shoulder will be randomized to two different treatments and the outcome will be measured.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis
Keywords
Randomized study capsulotomy vs distention with steroid

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Arthroscopic Capsulotomy
Arm Type
Active Comparator
Arm Description
Arthroscopic capsular release
Arm Title
Distention with steroid
Arm Type
Active Comparator
Arm Description
Arthrographic distention with contrast, saline, steroid and local anaesthetic
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic capsular release
Intervention Description
Surgical division of thickened capsule in the shoulder
Intervention Type
Procedure
Intervention Name(s)
Distention with steroid
Intervention Description
Intraarticular distention with steroid, saline, contrast and local anaesthetic
Primary Outcome Measure Information:
Title
Shoulder Function
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Shoulder range of motion
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient must have understood all information about the project and must have signed the informed consent letter about participation in the study including rehabilitation and follow-up The patients must have a history and clinical findings typical for primary frozen shoulder with globally reduced range of motion in the shoulder. External rotation 20 degrees or less Abduction 45 degrees or less The patients must not be in phase 1 (inflammation phase) Diabetics may be included MRI must be taken to exclude other reasons for stiffness Exclusion Criteria: Other reasons for stiffness( cuff rupture, arthritis) Posttraumatic or postoperative stiffness Patients not suited for day surgery Patients with a history of subacromial impingement before developing stiffness
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ove K Austgulen, MD
Phone
+4793232026
Email
ovaust@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jannike Øyen, M Sc
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eirik J Solheim, MD, PhD
Organizational Affiliation
University of Bergen, Surgical Dept.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Leiv Hove, MD, PhD
Organizational Affiliation
University of Bergen, Surgical Dept.
Official's Role
Study Director
Facility Information:
Facility Name
Haraldsplass Deaconess Hospital
City
Bergen
State/Province
Hordaland
ZIP/Postal Code
5009
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesper Blomquist, MD
Phone
+4755978500
Email
jblo@haraldsplass.no

12. IPD Sharing Statement

Citations:
Citation
Codman EA. The Shoulder: Rupture of the Supraspinatus Tendon and Other Lesions In or About the Subacromial Bursa. Boston: Thomas Todd Co; 1934.
Results Reference
background
PubMed Identifier
5008469
Citation
Bridgman JF. Periarthritis of the shoulder and diabetes mellitus. Ann Rheum Dis. 1972 Jan;31(1):69-71. doi: 10.1136/ard.31.1.69. No abstract available.
Results Reference
background
PubMed Identifier
2436441
Citation
Moren-Hybbinette I, Moritz U, Schersten B. The clinical picture of the painful diabetic shoulder--natural history, social consequences and analysis of concomitant hand syndrome. Acta Med Scand. 1987;221(1):73-82. doi: 10.1111/j.0954-6820.1987.tb01247.x.
Results Reference
background
PubMed Identifier
670287
Citation
Grey RG. The natural history of "idiopathic" frozen shoulder. J Bone Joint Surg Am. 1978 Jun;60(4):564. No abstract available.
Results Reference
result
PubMed Identifier
1198072
Citation
Reeves B. The natural history of the frozen shoulder syndrome. Scand J Rheumatol. 1975;4(4):193-6. doi: 10.3109/03009747509165255.
Results Reference
result
PubMed Identifier
6742896
Citation
Binder AI, Bulgen DY, Hazleman BL, Roberts S. Frozen shoulder: a long-term prospective study. Ann Rheum Dis. 1984 Jun;43(3):361-4. doi: 10.1136/ard.43.3.361.
Results Reference
result
Citation
Duplay ES. De la periarthrite scapulo-humérale et des raideurs de l'épaule qui en sont la conséquence. Arch Gen Med 1872;20:513-42.
Results Reference
result
PubMed Identifier
16356983
Citation
Dias R, Cutts S, Massoud S. Frozen shoulder. BMJ. 2005 Dec 17;331(7530):1453-6. doi: 10.1136/bmj.331.7530.1453.
Results Reference
result
PubMed Identifier
1624489
Citation
Shaffer B, Tibone JE, Kerlan RK. Frozen shoulder. A long-term follow-up. J Bone Joint Surg Am. 1992 Jun;74(5):738-46.
Results Reference
result
PubMed Identifier
3708230
Citation
Pal B, Anderson J, Dick WC, Griffiths ID. Limitation of joint mobility and shoulder capsulitis in insulin- and non-insulin-dependent diabetes mellitus. Br J Rheumatol. 1986 May;25(2):147-51. doi: 10.1093/rheumatology/25.2.147.
Results Reference
result
PubMed Identifier
7559688
Citation
Bunker TD, Anthony PP. The pathology of frozen shoulder. A Dupuytren-like disease. J Bone Joint Surg Br. 1995 Sep;77(5):677-83.
Results Reference
result

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Surgery or Capsular Distention With Steroid in the Treatment of Primary Frozen Shoulder?

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