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Operative or Conservative Treatment for Subacromial Impingement Syndrome?

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. Identifier: NCT00428870
Recruitment Status : Active, not recruiting
First Posted : January 30, 2007
Last Update Posted : September 20, 2018
Information provided by (Responsible Party):
Mika Paavola, University of Helsinki

Brief Summary:
pShoulder impingement syndrome is common and number of operations done per year is growing. The aim of this study is to compare the value of arthroscopic subacromial decompression (acromioplasty group) vs. diagnostic arthroscopy (control group) vs. supervised exercise therapy (conservative group) on subjects with chronic subacromial impingement syndrome. The results of treatment are measured at 3 months, 6 months, 12 months, 24 months, 5 years and 10 years. Primary outcome measures are pain at rest and activity (VASs) and secondary outcomes are functional assessment of the shoulder with Constant score and Simple Shoulder test (SST), global assessment of change , quality of life assessment (SF-36 and 15D) and costs. At 10 year follow-up, MRI imaging is obtained and the findings compared to baseline imaging.

Condition or disease Intervention/treatment Phase
Subacromial Impingement Syndrome Procedure: Arthroscopic acromioplasty or arthroscopy alone (sham) or conservative treatment (rehabilitation) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Arthroscopic Decompression Versus Diagnostic Arthroscopy Without Subacromial Decompression Versus Supervised Exercise Therapy in Treatment of Subacromial Impingement Syndrome. A Blinded Randomized Controlled Trail.
Study Start Date : February 2005
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Arm Intervention/treatment
Experimental: Arthroscopic acromioplasty
Arthroscopic acromioplasty
Procedure: Arthroscopic acromioplasty or arthroscopy alone (sham) or conservative treatment (rehabilitation)
Placebo Comparator: Sham surgery
Shoulder arthroscopy without active treatment and subacromial arthroscopy without bursectomy, decompression or other active interventions
Procedure: Arthroscopic acromioplasty or arthroscopy alone (sham) or conservative treatment (rehabilitation)
Active Comparator: Conservative treatment
Standardized exercise rehabilitation (supervised by physiotherapist)
Procedure: Arthroscopic acromioplasty or arthroscopy alone (sham) or conservative treatment (rehabilitation)

Primary Outcome Measures :
  1. Pain at rest [ Time Frame: 2 years (primary) ]
    Assessed with 10-cm visual analog scales (VASs).

  2. Pain during activity [ Time Frame: 2 years (primary) ]
    Assessed with 10-cm visual analog scales (VASs).

Secondary Outcome Measures :
  1. Constant score and Simple Shoulder test [ Time Frame: 2 years (primary) ]
    Functional assessment of the shoulder

  2. global assessment of change, [ Time Frame: 2 years (primary) ]
    Likert scale

  3. SF-36 and 15D [ Time Frame: 2 years (primary) ]
    Quality of life assessment

  4. Costs [ Time Frame: 2 years (primary) ]
    Resource use

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

In the first phase orthopaedists select consecutive female or male patients who are admitted to the hospital policlinic of Helsinki University Hospital, (either Töölö Hospital or Jorvi Hospital) or District Hospital of Tampere (Hatanpää Hospital) and fulfill the following inclusion criteria:

  1. Subjects are 35 to 65 years of age female or male and have a characteristic history and symptoms of subacromial impingement syndrome at least 3 months.
  2. Symptoms have no relieved with appropriate conservative treatment (i.e. physiotherapy, NSAIDs and subacromial corticosteroid injection).
  3. They have clinical findings of impingement syndrome; painful arc sign and pain in shoulder abduction, positive findings in two of three isometric shoulder abduction tests (0 degree, 30 degree and external rotation), and positive subacromial injection test.

Exclusion Criteria:

  1. Previous surgery of affected shoulder
  2. Symptomatic osteoarthrosis of acromio-clavicular joint
  3. Full thickness rotator cuff tear based on clinical findings and MRI
  4. Long-term cervical syndrome
  5. Instability of shoulder
  6. Reluctance to participate in any study groups (i.e. any treatment options of the study)
  7. Reduced co-operation (drug or alcohol abuse, mental illness)

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 identifier (NCT number): NCT00428870

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Helsinki University Hospital, Töölö Hospital
Helsinki, HUS, Finland, FIN-00029
Sponsors and Collaborators
University of Helsinki
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Principal Investigator: Mika Paavola, MD, PhD 1.1.2003
Study Chair: Teppo Jarvinen, MD, PhD 1.1.2004
Study Chair: Antti Malmivaara, MD, PhD 1.8.2004
Study Chair: Timo Järvelä, MD, PhD 1.1.2004
Study Chair: Simo Taimela, MD, PhD 1.6.2004
Study Chair: Harri Sintonen, Professor 1.8.2004
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Mika Paavola, MD, PhD, University of Helsinki Identifier: NCT00428870    
Other Study ID Numbers: R04200
First Posted: January 30, 2007    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018
Keywords provided by Mika Paavola, University of Helsinki:
Additional relevant MeSH terms:
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Shoulder Impingement Syndrome
Rotator Cuff Injuries
Pathologic Processes
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Joint Diseases
Musculoskeletal Diseases