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Operative Versus Non-operative Management of Subacromial Impingement

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00637013
First Posted: March 17, 2008
Last Update Posted: February 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Academy of Finland
Oulu University Hospital
Information provided by (Responsible Party):
Ilkka Kiviranta, Professor, Central Finland Hospital District
  Purpose

The study aims at determining the effectiveness and cost-effectiveness of surgical management of subacromial impingement (including partial tears) compared to conservative treatment. The research setting is prospective, randomised, and controlled.

The aim of the study is to search out evidence based data of indications for subacromial decompression. The investigators also aim at offering patients the most efficient and effective treatment and reduce the number of operations that do not have sufficient effectiveness. The data obtained will facilitate developing guidelines for referrals to a specialist when subacromial impingement is suspected.

The investigators hypothesise that there are subgroups of patients suffering from subacromial impingement that benefit from surgery whereas other subgroups are best treated conservatively.


Condition Intervention
Subacromial Impingement Syndrome Procedure: Acromioplasty Procedure: Physiotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effectiveness and Cost-effectiveness of Operative Versus Non-operative Management of Subacromial Impingement

Further study details as provided by Ilkka Kiviranta, Professor, Central Finland Hospital District:

Primary Outcome Measures:
  • Change in pain (VAS) and objective shoulder function (Constant score) [ Time Frame: 24 months after intervention ]

Secondary Outcome Measures:
  • Change in pain (VAS) and objective shoulder function (Constant score) [ Time Frame: 3 months after intervention ]
  • Change in pain (VAS) and objective shoulder function (Constant score) [ Time Frame: 6 months after intervention ]
  • Change in pain (VAS) and objective shoulder function (Constant score) [ Time Frame: 12 months after intervention ]
  • Change in pain (VAS) and objective shoulder function (Constant score) [ Time Frame: 5 years after uintervention ]

Estimated Enrollment: 100
Actual Study Start Date: June 2008
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Acromioplasty
Acromioplasty + physiotherapy according to a standardized protocol following a 3 months period of active non-operative treatment
Procedure: Acromioplasty
Arthroscopic or open acromioplasty
Other Name: Subacromial decompression
Active Comparator: Physiotherapy
Physiotherapy according to a standardized protocol following a 3 months period of active non-operative treatment
Procedure: Physiotherapy
Physiotherapy according to a standardized protocol
Other Names:
  • Physical therapy
  • Non-operative treatment

Detailed Description:

Subgroup analysis:

  • age
  • sex
  • duration of symptoms
  • presence of trauma before symptoms
  • presence of partial tear
  • degenerative findings
  • other findings in MRI or arthroscopy
  • type of operation
  • co-morbidities
  • occupation
  • pain (VAS)
  • objective shoulder function
  • activities of daily living
  Eligibility

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Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age over 35 years old
  • duration of symptoms at least three months despite non-operative treatment
  • accepts both treatment options (operative and physical therapy)
  • must have pain in abduction of the shoulder
  • must have painful arc
  • must have pain in two of the three isometric tests (0 and 30 degrees of abduction, or external rotation)
  • a positive result in the impingement test (a subacromial injection of lidocaine reduces pain)

Exclusion Criteria:

  • previous shoulder operations
  • too high risk for operation
  • any disease or social problem reducing the ability to co-operate
  • rheumatoid arthritis
  • severe arthrosis of the glenohumeral or acromioclavicular joint
  • a full-thickness rotator cuff tear in MRI arthrography
  • a progressive malign disease
  • adhesive capsulitis
  • high-energy trauma before symptoms
  • cervical syndrome
  • shoulder instability
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00637013


Locations
Finland
Central Finland Health District
Jyväskylä, Finland, FIN-40620
Sponsors and Collaborators
Central Finland Hospital District
Academy of Finland
Oulu University Hospital
Investigators
Principal Investigator: Ilkka Kiviranta, MD, PhD Helsinki University
  More Information

Additional Information:
Publications:

Responsible Party: Ilkka Kiviranta, Professor, Md, PhD, Central Finland Hospital District
ClinicalTrials.gov Identifier: NCT00637013     History of Changes
Other Study ID Numbers: B07103
First Submitted: March 10, 2008
First Posted: March 17, 2008
Last Update Posted: February 1, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Ilkka Kiviranta, Professor, Central Finland Hospital District:
Subacromial impingement
Shoulder
RCT
Effectiveness
Cost-effectiveness

Additional relevant MeSH terms:
Shoulder Impingement Syndrome
Joint Diseases
Musculoskeletal Diseases