Subacromial Impingement - The Need of Arthroscopic Subacromial Decompression After Eccentric Physical Therapy Exercises

June 16, 2011 updated by: Linkoeping University

Does the Need of Arthroscopic Subacromial Decompression Change After Eccentric Physical Therapy Exercises in Patients With Subacromial Pain? - A Randomized Clinical Trial

Objective:

A randomized clinical trial in order to evaluate the efficacy of structured eccentric exercises tutored by a physical therapist (PT) for patients with subacromial impingement.

Hypothesis:

H1 The exercises has a satisfactory effect and the need of an arthroscopic subacromial decompression can be reconsidered.

H0 No difference between the two exercises (experimental and active control) and the patients still need surgery

Further the study objective is to evaluate predictors for a positive or negative treatment response after three months of rehabilitation as well as after 12 months.

Method:

Patients referred to the orthopedic unit for an arthroscopic subacromial decompression, are offered a three month rehabilitation program during the waiting time for surgery which is approximately 4-6 months. All patients must have tried conservative treatments for at least 6 months in primary care with unsatisfactory results. The patients will be randomized to either the structured eccentric exercises tutored by a physical therapist or control exercises with general movements for the neck and shoulders. All patients has an equal number of sessions with the PT to offer similar attention. After three months the following key-question has to be answered: due to your current experience of your shoulder problems do you still need this surgical intervention? A blinded orthopedic surgeon evaluates the following outcomes at baseline and after three and twelve months. Primary outcomes: Constant-Murley shoulder assessment, Disabilities of the Arm Shoulder and Hans and different aspects of pain. Secondary outcomes; EQ-5D, sick-leave and return to work. All patients are evaluated with a diagnostic ultrasound in order to reveal the condition of the rotator cuff. Also long-term results in those who go thorough with the surgery and those who decline will be assessed after 12 months.

Importance of the study results:

Since there is no consensus about which intervention that should be preferred for patients with subacromial impingement the results of the current study is warranted. If this exercise program is successful it can be implemented into clinical practice. Further, clinical characteristics of patients that really need an arthroscopic subacromial decompression can be identified.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

102

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

  • Sweden
      • Linköping, Sweden, 581 85
        • 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

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subacromial impingement verified with Neer impingement injection test
  • At least 6 months duration
  • Treated in primary care without satisfactory result for at least 6 months

Three of these five must be positive:

  • Neer impingement sign
  • Hawkins-Kennedy impingement sign
  • Jobe supraspinatus test
  • Patte maneuver
  • Typical history and pain location (C5 dermatome)

Exclusion Criteria:

  • Radiological finding of malignancy, osteoarthritis, fractures
  • Polyarthritis or fibromyalgia
  • Pathological hyper-laxity or dislocation of the any of the shoulder joints
  • Cervical spine pathology
  • Lack of communication skills that prevent the use of outcome measures

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PT progressive exercises
A progressive program of movement and strength exercises for the rotator cuff and scapular muscles combined with mobilisation of the joint capsule when needed
Procedure: Exercise program
A progressive program where load and complexity increases during a 3 month period. Initially PT-tutored every week and then every other week.
Other Names:
  • Exercises
  • Scapular stabilization
  • Eccentric
  • Rotator cuff
Active Comparator: Movement exercises neck and shoulder
General movements for the neck and shoulder,
Procedure: Exercise program
A progressive program where load and complexity increases during a 3 month period. Initially PT-tutored every week and then every other week.
Other Names:
  • Exercises
  • Scapular stabilization
  • Eccentric
  • Rotator cuff
Procedure: Movement exercises
A program with the same movements to maintain flexibility in the neck and shoulder. Initially PT-tutored every week and then every other week.
Other Names:
  • Exercises
  • posture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Constant-Murley shoulder assessment
Time Frame: Baseline and change after three months of exercises, 3 month follow-up

Measure a combination of self assessed and clinician assessed items; pain, range-of-motion (flexion and abduction), functional positions (hand in neck as well as hand in back), abduction strength.

The score is summarized to a maximum of 100 for best available shoulder function.
Baseline and change after three months of exercises, 3 month follow-up
Constant_Murley shoulder assessment
Time Frame: Change from baseline to the 12-month follow-up

Measure a combination of self assessed and clinician assessed items; pain, range-of-motion (flexion and abduction), functional positions (hand in neck as well as hand in back), abduction strength.

The score is summarized to a maximum of 100 for best available shoulder function.
Change from baseline to the 12-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health Related Quality of Life by EuroQol 5 dimensions
Time Frame: Baseline and change aftert three months of exercises
Measures different items related to heath related quality of life: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. It results in a health-state where an index of 1 is optimal.
Baseline and change aftert three months of exercises
Health Related Quality of Life by EuroQol 5 dimensions
Time Frame: Change from baseline to the 12-month follow-up
Measures different items related to heath related quality of life: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. It results in a health-state where an index of 1 is optimal.
Change from baseline to the 12-month follow-up

Collaborators and Investigators

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

Sponsor

Linkoeping University

Investigators

  • Study Chair: Kajsa Johansson, PhD, RPT, Linkoeping University

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

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

January 1, 2008

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

December 22, 2009

First Submitted That Met QC Criteria

December 22, 2009

First Posted (Estimate)

December 23, 2009

Study Record Updates

Last Update Posted (Estimate)

June 17, 2011

Last Update Submitted That Met QC Criteria

June 16, 2011

Last Verified

December 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 88201401

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.

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