- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04915430
Training in Subacromial Impingement Syndrome
Comprehensive Supervised Heavy Training Program Versus Home Training Regimen in Patients With Subacromial Impingement Syndrome: a Randomized Trial.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of the study is to compare a comprehensive supervised training regimen (STR) based on latest evidence including heavy slow resistance training with a validated home-based regimen (HTR). We hypothesized that the STR would be superior to the HTR.
Randomised control trial with blinded assessor. 126 consecutive patients with subacromial impingement syndrome were recruited and equally randomised to 12 weeks of either supervised training regimen (STR), or home-based training regimen (HTR). Primary outcomes were Constant Score (CS) and Shoulder Rating Questionnaire (SRQ) from baseline and 6 months after completed training. Results were analyzed according to intention-to treat principles.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subacromial impingement syndrome
Exclusion Criteria:
- Ongoing claim with the Labour market insurance, insurance company or comparable institution.
- Ongoing application for job revalidation or health related pension.
- Radiating neck pain.
- Ultrasound verified complete rotator cuff tendon lesion, as defined by hypoechoic or anechoic full thickness defect of the tendon, or absence of the tendon.
- Periarthritis humeroscapularis.
- Acute luxation or fracture of the shoulder.
- Ongoing steady analgetic treatment of other concomitant painful condition, unrelated to the patients shoulder problem.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Supervised training regimen
This training regimen consisted of 3 phases: the 1st focused on restoring motion, the 2nd on strengthening of the rotator cuff muscles, and the 3rd on strengthening of the scapular muscles. Stretching completed every training session.
Exercises were performed 3 times a week, with progression after the 1st week, and thereafter every 2nd week. |
|
Active Comparator: Home training regimen
The program consisted of the following:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Shoulder constant score
Time Frame: 6 months after ended training
|
Functional assessment of the shoulder
|
6 months after ended training
|
Shoulder Rating Questionnaire
Time Frame: 6 months after ended training
|
Self-administered questionnaire
|
6 months after ended training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Passive motion
Time Frame: 6 months after ended training
|
Shoulder flexion, measurement in degrees; Shoulder abduction, measurement in degrees; Shoulder internal rotation, measurement in degrees; Shoulder external rotation, measurement in degrees.
|
6 months after ended training
|
Active motion
Time Frame: 6 months after ended training
|
Shoulder flexion, measurement in degrees; Shoulder abduction, measurement in degrees; Shoulder internal rotation, measurement in degrees; Shoulder external rotation, measurement in degrees.
|
6 months after ended training
|
Visual Analogue Scale
Time Frame: 6 months after ended training
|
Measurement of pain on a 10 cm scale, where 0 indicates no pain, and 10 worst pain for the following muscle tests: full can test, empty can test, lift off test, resisted external rotation, palm-up test, Yergason´s test.
|
6 months after ended training
|
Neer test
Time Frame: 6 months after ended training
|
Stabilization of the patient's scapula with one hand, while passively flexing the arm while it is internally rotated.
If the patient reports pain in this position, then the result of the test is considered to be positive (rated positive = 1 and negative = 0).
|
6 months after ended training
|
Hawkins test
Time Frame: 6 months after ended training
|
Placing the patient's shoulder in 90 degrees of shoulder flexion with the elbow flexed to 90 degrees, and afterwards internally rotating the arm.
The test is considered to be positive if the patient experiences pain with internal rotation (rated positive = 1 and negative = 0).
|
6 months after ended training
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Pierre Schydlowsky, MD, PhD, Owner of the clinics
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PS_01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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