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Operative Versus Non-operative Management of Subacromial Impingement

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ClinicalTrials.gov Identifier: NCT00637013
Recruitment Status : Active, not recruiting
First Posted : March 17, 2008
Last Update Posted : November 17, 2017
Sponsor:
Collaborators:
Academy of Finland
Oulu University Hospital
Information provided by (Responsible Party):
Ilkka Kiviranta, Professor, Central Finland Hospital District

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.


Condition or disease Intervention/treatment
Subacromial Impingement Syndrome Procedure: Acromioplasty Procedure: Physiotherapy

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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
Actual Study Start Date : June 2008
Primary Completion Date : January 2017
Estimated Study Completion Date : January 2027

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Change in pain (VAS) and objective shoulder function (Constant score) [ Time Frame: 24 months after intervention ]
    VAS (0 to 100 mm), Constant score (0 to 100 points)


Secondary Outcome Measures :
  1. Change in pain (VAS) and objective shoulder function (Constant score) [ Time Frame: 3 months after intervention ]
    VAS (0 to 100 mm), Constant score (0 to 100 points)

  2. Change in pain (VAS) and objective shoulder function (Constant score) [ Time Frame: 6 months after intervention ]
    VAS (0 to 100 mm), Constant score (0 to 100 points)

  3. Change in pain (VAS) and objective shoulder function (Constant score) [ Time Frame: 12 months after intervention ]
    VAS (0 to 100 mm), Constant score (0 to 100 points)

  4. Change in pain (VAS) and objective shoulder function (Constant score) [ Time Frame: 5 years after uintervention ]
    VAS (0 to 100 mm), Constant score (0 to 100 points)



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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

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

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 Posted: March 17, 2008    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 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
Shoulder Injuries
Wounds and Injuries