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Completed

NCT Number: NCT01037673

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

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.

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Linköping, 581 85, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise program

Procedure

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

Movement exercises

Procedure

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Dec 23, 2009
Registry last updated
Jun 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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