Operative or Conservative Treatment for Subacromial Impingement Syndrome?

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mika Paavola, Helsinki University
ClinicalTrials.gov Identifier:
NCT00428870
First received: January 29, 2007
Last updated: September 18, 2013
Last verified: September 2013
  Purpose

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 Phase
Subacromial Impingement Syndrome
Procedure: Arthroscopic acromioplasty or arthroscopy alone (sham) or conservative treatment (rehabilitation)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Helsinki University:

Primary Outcome Measures:
  • Pain at rest and activity assessed with 10-cm visual analog scales (VASs). [ Time Frame: 2 years (primary) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional assessment of the shoulder with Constant score and Simple Shoulder test, [ Time Frame: 2 years (primary) ] [ Designated as safety issue: No ]
  • global assessment of change, [ Time Frame: 2 years (primary) ] [ Designated as safety issue: No ]
  • quality of life assessment (SF-36 and 15D), [ Time Frame: 2 years (primary) ] [ Designated as safety issue: No ]
  • Costs [ Time Frame: 2 years (primary) ] [ Designated as safety issue: No ]

Enrollment: 210
Study Start Date: October 2005
Estimated Study Completion Date: December 2023
Estimated Primary Completion Date: August 2015 (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

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00428870

Locations
Finland
Helsinki University Hospital, Töölö Hospital
Helsinki, HUS, Finland, FIN-00029
Sponsors and Collaborators
Helsinki University
Investigators
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: Pekka Paavolainen, Professor 1.1.2003
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
Study Director: Markku Järvinen, Professor 1.1.2004
  More Information

No publications provided

Responsible Party: Mika Paavola, MD, PhD, Helsinki University
ClinicalTrials.gov Identifier: NCT00428870     History of Changes
Other Study ID Numbers: R04200
Study First Received: January 29, 2007
Last Updated: September 18, 2013
Health Authority: Finland: Helsinki University Hospital
Finland: Tampere University Hospital

Keywords provided by Helsinki University:
Shoulder
impingement
conservative
acromioplasty
arthroscopy

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

ClinicalTrials.gov processed this record on April 16, 2014