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

This study has been completed.
Sponsor:
Information provided by:
Linkoeping University
ClinicalTrials.gov Identifier:
NCT01037673
First received: December 22, 2009
Last updated: June 16, 2011
Last verified: December 2009
History of Changes
  Purpose

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.


Condition Intervention
Subacromial Impingement Syndrome
 Procedure: Exercise program
Procedure: Movement exercises

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does the Need of Arthroscopic Subacromial Decompression Change After Eccentric Physical Therapy Exercises in Patients With Subacromial Pain? - A Randomized Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Linkoeping University:

Primary Outcome Measures:
  • Constant-Murley shoulder assessment [ Time Frame: Baseline and change after three months of exercises, 3 month follow-up ] [ Designated as safety issue: No ]

    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.


  • Constant_Murley shoulder assessment [ Time Frame: Change from baseline to the 12-month follow-up ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Health Related Quality of Life by EuroQol 5 dimensions [ Time Frame: Baseline and change aftert three months of exercises ] [ Designated as safety issue: No ]
    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.

  • Health Related Quality of Life by EuroQol 5 dimensions [ Time Frame: Change from baseline to the 12-month follow-up ] [ Designated as safety issue: No ]
    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.


Enrollment: 102
Study Start Date: January 2008
Study Completion Date: June 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Eccentric
  • Rotator cuff
  • Exercises
  • Scapular stabilization
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:
  • Eccentric
  • Rotator cuff
  • Exercises
  • Scapular stabilization
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

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01037673

Locations
Sweden
University Hospital
Linköping, Sweden, 581 85
Sponsors and Collaborators
Linkoeping University
Investigators
Study Chair: Kajsa Johansson, PhD, RPT Linköping University
  More Information

No publications provided by Linkoeping University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kajsa Johansson, Senior lecturer, Linköping University
ClinicalTrials.gov Identifier: NCT01037673     History of Changes
Other Study ID Numbers: 88201401
Study First Received: December 22, 2009
Last Updated: June 16, 2011
Health Authority: Sweden: The National Board of Health and Welfare

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

ClinicalTrials.gov processed this record on June 17, 2013