An interventional study of Exercise program and Movement exercises in Subacromial Impingement Syndrome, sponsored by Linkoeping University. Completed at 1 site in Sweden. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2011-06-17.
Sponsored by Linkoeping University · Not applicable, Interventional, and Treatment
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.
304 studies on the registry are indexed under Shoulder Impingement Syndrome; 55 are open to participants now.
This study's enrollment of 102 is above the median of 54 across 261 interventional studies indexed under Shoulder Impingement Syndrome.
Browse Shoulder Impingement Syndrome studies →Linkoeping University is the lead sponsor of 189 studies on the registry; 40 are open to participants now.
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Three of these five must be positive:
Exclusion Criteria:
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
General movements for the neck and shoulder,
Procedure: Exercise program · Procedure: Movement exercises
A progressive program where load and complexity increases during a 3 month period. Initially PT-tutored every week and then every other week.
Also known as: Eccentric, Rotator cuff, Exercises, Scapular stabilization
A program with the same movements to maintain flexibility in the neck and shoulder. Initially PT-tutored every week and then every other week.
Also known as: Exercises, posture
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.
Time frame: Baseline and change after three months of exercises, 3 month follow-up
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.
Time frame: Change from baseline to the 12-month follow-up
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.
Time frame: Baseline and change aftert three months of exercises
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.
Time frame: Change from baseline to the 12-month follow-up
This study is completed, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.
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