Operative Versus Non-operative Management of Subacromial Impingement

February 11, 2024 updated by: Juha Paloneva, Central Finland Hospital District

The Effectiveness and Cost-effectiveness of Operative Versus Non-operative Management of Subacromial Impingement

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland
        • University of Helsinki
      • Jyväskylä, Finland, FIN-40620
        • Central Finland Health District
      • Oulu, Finland
        • Oulu University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
24 months after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3 months after intervention
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)
6 months after intervention
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)
12 months after intervention
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)
5 years after uintervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Finland Hospital District

Collaborators

Oulu University Hospital
Academy of Finland

Investigators

  • Principal Investigator: Juha Paloneva, MD, PhD, Central Finland Health Care District, University of Eastern Finland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2008

Primary Completion (Actual)

January 1, 2017

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

March 10, 2008

First Submitted That Met QC Criteria

March 10, 2008

First Posted (Estimated)

March 17, 2008

Study Record Updates

Last Update Posted (Actual)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 11, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B07103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Subacromial Impingement Syndrome

Clinical Trials on Acromioplasty

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe