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Operative or Conservative Treatment for Subacromial Impingement Syndrome?

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Mika Paavola, Helsinki University Identifier:
First received: January 29, 2007
Last updated: February 6, 2017
Last verified: February 2017
Shoulder 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 and 24 months. Main outcome measures are Pain at rest and activity (VASs), 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.

Condition Intervention
Subacromial Impingement Syndrome
Procedure: Arthroscopic acromioplasty or arthroscopy alone (sham) or conservative treatment (rehabilitation)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Further study details as provided by Mika Paavola, Helsinki University:

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

Secondary Outcome Measures:
  • Functional assessment of the shoulder with Constant score and Simple Shoulder test, [ Time Frame: 2 years (primary) ]
  • global assessment of change, [ Time Frame: 2 years (primary) ]
  • quality of life assessment (SF-36 and 15D), [ Time Frame: 2 years (primary) ]
  • Costs [ Time Frame: 2 years (primary) ]

Enrollment: 210
Study Start Date: February 2005
Estimated Study Completion Date: December 2024
Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Show Detailed Description


Ages Eligible for Study:   35 Years to 65 Years   (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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT00428870

Helsinki University Hospital, Töölö Hospital
Helsinki, HUS, Finland, FIN-00029
Sponsors and Collaborators
Helsinki University
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
  More Information

Responsible Party: Mika Paavola, MD, PhD, Helsinki University Identifier: NCT00428870     History of Changes
Other Study ID Numbers: R04200
Study First Received: January 29, 2007
Last Updated: February 6, 2017

Keywords provided by Mika Paavola, Helsinki University:

Additional relevant MeSH terms:
Shoulder Impingement Syndrome
Pathologic Processes
Joint Diseases
Musculoskeletal Diseases processed this record on May 25, 2017