Subacromial Impingement - The Need of Arthroscopic Subacromial Decompression After Eccentric Physical Therapy Exercises
Primary Purpose
Subacromial Impingement Syndrome
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Exercise program
Movement exercises
Sponsored by
About this trial
This is an interventional treatment trial for Subacromial Impingement Syndrome
Eligibility 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
Sites / Locations
- University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PT progressive exercises
Movement exercises neck and shoulder
Arm Description
A progressive program of movement and strength exercises for the rotator cuff and scapular muscles combined with mobilisation of the joint capsule when needed
General movements for the neck and shoulder,
Outcomes
Primary Outcome Measures
Constant-Murley shoulder assessment
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
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01037673
Brief Title
Subacromial Impingement - The Need of Arthroscopic Subacromial Decompression After Eccentric Physical Therapy Exercises
Official Title
Does the Need of Arthroscopic Subacromial Decompression Change After Eccentric Physical Therapy Exercises in Patients With Subacromial Pain? - A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Linkoeping University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Impingement Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PT progressive exercises
Arm Type
Experimental
Arm Description
A progressive program of movement and strength exercises for the rotator cuff and scapular muscles combined with mobilisation of the joint capsule when needed
Arm Title
Movement exercises neck and shoulder
Arm Type
Active Comparator
Arm Description
General movements for the neck and shoulder,
Intervention Type
Procedure
Intervention Name(s)
Exercise program
Other Intervention Name(s)
Eccentric, Rotator cuff, Exercises, Scapular stabilization
Intervention Description
A progressive program where load and complexity increases during a 3 month period. Initially PT-tutored every week and then every other week.
Intervention Type
Procedure
Intervention Name(s)
Movement exercises
Other Intervention Name(s)
Exercises, posture
Intervention Description
A program with the same movements to maintain flexibility in the neck and shoulder. Initially PT-tutored every week and then every other week.
Primary Outcome Measure Information:
Title
Constant-Murley shoulder assessment
Description
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.
Time Frame
Baseline and change after three months of exercises, 3 month follow-up
Title
Constant_Murley shoulder assessment
Description
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.
Time Frame
Change from baseline to the 12-month follow-up
Secondary Outcome Measure Information:
Title
Health Related Quality of Life by EuroQol 5 dimensions
Description
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.
Time Frame
Baseline and change aftert three months of exercises
Title
Health Related Quality of Life by EuroQol 5 dimensions
Description
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.
Time Frame
Change from baseline to the 12-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kajsa Johansson, PhD, RPT
Organizational Affiliation
Linkoeping University
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital
City
Linköping
ZIP/Postal Code
581 85
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
25213604
Citation
Holmgren T, Hallgren HB, Oberg B, Adolfsson L, Johansson K. Effect of specific exercise strategy on need for surgery in patients with subacromial impingement syndrome: randomised controlled study. Br J Sports Med. 2014 Oct;48(19):1456-7. doi: 10.1136/bjsports-2014-e787rep.
Results Reference
derived
PubMed Identifier
24970843
Citation
Hallgren HC, Holmgren T, Oberg B, Johansson K, Adolfsson LE. A specific exercise strategy reduced the need for surgery in subacromial pain patients. Br J Sports Med. 2014 Oct;48(19):1431-6. doi: 10.1136/bjsports-2013-093233. Epub 2014 Jun 26.
Results Reference
derived
PubMed Identifier
22349588
Citation
Holmgren T, Bjornsson Hallgren H, Oberg B, Adolfsson L, Johansson K. Effect of specific exercise strategy on need for surgery in patients with subacromial impingement syndrome: randomised controlled study. BMJ. 2012 Feb 20;344:e787. doi: 10.1136/bmj.e787.
Results Reference
derived
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Subacromial Impingement - The Need of Arthroscopic Subacromial Decompression After Eccentric Physical Therapy Exercises
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