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Operative Versus Non-operative Management of Subacromial Impingement

This study is currently recruiting participants.
Verified February 2012 by Central Finland Hospital District
Sponsor:
Collaborators:
Academy of Finland
National Istitute For Health and Welfare, Finland
Information provided by (Responsible Party):
Ilkka Kiviranta, Professor, Central Finland Hospital District
ClinicalTrials.gov Identifier:
NCT00637013
First received: March 10, 2008
Last updated: February 9, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention
Subacromial Impingement Syndrome
 Procedure: Surgery (Subacromial decompression)
Procedure: Non-operative treatment (Physical therapy)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effectiveness and Cost-effectiveness of Operative Versus Non-operative Management of Subacromial Impingement

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Central Finland Hospital District:

Primary Outcome Measures:
  • Change in pain (VAS) and objective shoulder function (Constant score) [ Time Frame: 24 months after intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in pain (VAS) and objective shoulder function (Constant score) [ Time Frame: 3 months after intervention ] [ Designated as safety issue: No ]
  • Change in pain (VAS) and objective shoulder function (Constant score) [ Time Frame: 6 months after intervention ] [ Designated as safety issue: No ]
  • Change in pain (VAS) and objective shoulder function (Constant score) [ Time Frame: 12 months after intervention ] [ Designated as safety issue: No ]
  • Change in pain (VAS) and objective shoulder function (Constant score) [ Time Frame: 5 years after uintervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2008
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Acromioplasty
Acromioplasty + physical therapy according to a standardized protocol
 Procedure: Surgery (Subacromial decompression)
Acromioplasty
Other Name: Subacromial decompression
Active Comparator: Physiotherapy
Physiotherapy according to a standardized protocol
 Procedure: Non-operative treatment (Physical therapy)
Physiotherapy according to a standardized protocol
Other Name: Physical therapy

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
  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00637013

Contacts
Contact: Juha Paloneva, MD, PhD +358 14 2691811 juha.paloneva@ksshp.fi
Contact: Ilkka Kiviranta, MD, PhD +358 50 427 1807 ilkka.kiviranta@helsinki.fi

Locations
Finland
Central Finland Health District Recruiting
Jyväskylä, Finland, FIN-40620
Contact: Juha Paloneva, MD, PhD     +358 14 2691811     juha.paloneva@ksshp.fi    
Contact: Ilkka Kiviranta, MD, PhD     +358 50 427 1807     ilkka.kiviranta@helsinki.fi    
Principal Investigator: Juha Paloneva, MD, PhD            
Sub-Investigator: Sanna Koskela, MD            
Sub-Investigator: Timo Järvelä, MD, PhD            
Sub-Investigator: Hannu Kautiainen            
Sponsors and Collaborators
Central Finland Hospital District
Academy of Finland
National Istitute For Health and Welfare, Finland
Investigators
Principal Investigator: Ilkka Kiviranta, MD, PhD Helsinki University
  More 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
Study First Received: March 10, 2008
Last Updated: February 9, 2012
Health Authority: Finland: Ethics Committee

Keywords provided by Central Finland Hospital District:
Subacromial impingement
Shoulder
RCT
Effectiveness
Cost-effectiveness

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

ClinicalTrials.gov processed this record on May 21, 2013