Clinical Trial: Operative Versus Non-operative Management of Subacromial Impingement

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: The Effectiveness and Cost-effectiveness of Operative Versus Non-operative Management of Subacromial Impingement

Brief Summary:

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.


Detailed Summary:

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

Sponsor: Central Finland Hospital District

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

Original Primary Outcome: Change in pain (VAS) and objective shoulder function (Constant score) [ Time Frame: 3, 6, 12, 24 months and 5 years after intervention ]

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

Information By: Central Finland Hospital District

Dates:
Date Received: March 10, 2008
Date Started: June 2008
Date Completion: June 2017
Last Updated: January 31, 2017
Last Verified: January 2017