- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04434183
Comparison of the Effects of Home Exercise and Isokinetic Exercise Program in Subacromial Impingement Syndrome Patients
June 16, 2020 updated by: Sevgi Atar, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Comparison of the Effects of Home Exercise Program and Isokinetic Exercise Program on Pain, Muscle Strength, Functionality, Sense of Proprioception and Quality of Life in Subacromial Impingement Syndrome Patients
The aim of this study is to evaluate and compare the effects of home exercise program and isokinetic exercise program on pain, muscle strength, functionality, proprioception sensation and quality of life in patients with subacromial impingement syndrome.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study was designed prospectively.
A total of 50 patients with subacromial impingement syndrome according to clinical and MRI findings with shoulder pain for at least 3 months were included in the study.
Patients were randomly divided into two groups.
The first group (isokinetic exercise group, n = 25) was given isokinetic exercise.
The second group(home exercise group, n=25) was given home exercise program.
Patients were evaluated before and after treatment and 3 months after the end of treatment.
In the evaluation, VAS, Shoulder Pain and Disability Index, Constant Murley Scoring, Shoulder Disability Questionnaire, Health Assessment Questionnaire, Pittsburgh Sleep Quality Index, Humic Norm II isokinetic device were used.
At statistically evaluation of data Student T Test and Mann Whitney U tests were used.
In qualitative datas comparison Ki-Kare Test was used.
Significance was evaluated at the level of p< 0.05.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey, 34384
- Prof Dr Cemil Tascioglu City Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Shoulder pain and functional disability at least 6 months
Exclusion Criteria:
- Instability of shoulder, Stage 2-3 adhesive capsulitis, tendinitis or bursitis, cervical radiculopathy, underwent surgery, norological diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: isokinetic exercise
The group (isokinetic exercise group, n = 25) was given isokinetic exercise.
|
Compare and evaluate of the effects of the routin physical medicine and rehabilitation programs in impingement patients
Other Names:
|
Active Comparator: home exercise
The group(home exercise group, n=25) was given home exercise program.
|
Compare and evaluate of the effects of the routin physical medicine and rehabilitation programs in impingement patients
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of shoulder examination findings
Time Frame: 3 months
|
The investigators evaluated to pre-treatment, intermediate post-treatment, and late post-treatment shoulder examination findings.
The investigators used to painful arc test consisting of 13 questions that scored from zero to ten.
|
3 months
|
Assessment of shoulder functions
Time Frame: 3 months
|
The investigators evaluated to pre-treatment, intermediate post-treatment, and late post-treatment shoulder functions and muscle strenght.
The investigators used to Constant-Murley functional evaluate scale consisting of four parameters that scored from zero to one hundered.
|
3 months
|
Assessment of muscle strenght
Time Frame: 3 months
|
The investigators evaluated it with isokinetic cybex dynamometer.
The isokinetic cybex dynamometer assessments using newton-meter for muscle strenght and angle degree for velocity measurements.
|
3 months
|
Assessment of quality of life
Time Frame: 3 months
|
The investigators evaluated to pre-treatment, intermediate post-treatment, and late post-treatment quality of life values with Pittsburg sleep quality index.
The Pittsburg sleep quality index consisting of 23 questions that scored from zero to three.
|
3 months
|
Assessment of sense of proprioseption
Time Frame: 3 months
|
The investigators evaluated it with isokinetic cybex dynamometer.
The isokinetic cybex dynamometer assessments using angle degree for sense of position.
|
3 months
|
Assessment of shoulder pain
Time Frame: 3 months
|
The investigators evaluated to pre-treatment, intermediate post-treatment, and late post-treatment for shoulder pain.
The investigators used to visual analog score for pain that scored from zero to ten.
|
3 months
|
Assessment of shoulder disability
Time Frame: 3 months
|
The investigators evaluated to pre-treatment, intermediate post-treatment, and late post-treatment for shoulder disability.
The investigators used to shoulder disability questionnare consisting of 16 questions that scored yes or no.
Calculation; score = [Yes counts / (Yes counts + No counts)]x100.
The score seems, zero point is maximal fine health and 100 points (maximal point) is poor health.
|
3 months
|
Assessment of physical health situation
Time Frame: 3 months
|
The investigators evaluated to pre-treatment, intermediate post-treatment, and late post-treatment for physical health situation.
The investigators used to health evaluated inventory.
The inventroy consisting of 20 questions that scored from zero to three per question.
Zero point is maximal fine health and 60 points are maximal poor health.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: OMER KURU, FULL PROF, Prof. Dr. Cemil Taşçıoğlu City Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Akman S, Kucukkaya M. [Subacromial impingement syndrome: pathogenesis, clinical features, and examination methods]. Acta Orthop Traumatol Turc. 2003;37 Suppl 1:27-34. Turkish.
- Campbell RS, Dunn A. External impingement of the shoulder. Semin Musculoskelet Radiol. 2008 Jun;12(2):107-26. doi: 10.1055/s-2008-1078699.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 30, 2018
Primary Completion (Actual)
November 30, 2018
Study Completion (Actual)
November 30, 2018
Study Registration Dates
First Submitted
June 9, 2020
First Submitted That Met QC Criteria
June 12, 2020
First Posted (Actual)
June 16, 2020
Study Record Updates
Last Update Posted (Actual)
June 18, 2020
Last Update Submitted That Met QC Criteria
June 16, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 851
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
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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