Comparison of the Effects of Home Exercise and Isokinetic Exercise Program in Subacromial Impingement Syndrome Patients
Primary Purpose
Home Exercise, Quality of Life
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercises of rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Home Exercise
Eligibility Criteria
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
Sites / Locations
- Prof Dr Cemil Tascioglu City Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
isokinetic exercise
home exercise
Arm Description
The group (isokinetic exercise group, n = 25) was given isokinetic exercise.
The group(home exercise group, n=25) was given home exercise program.
Outcomes
Primary Outcome Measures
Assessment of shoulder examination findings
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.
Assessment of shoulder functions
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.
Assessment of muscle strenght
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.
Assessment of quality of life
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.
Assessment of sense of proprioseption
The investigators evaluated it with isokinetic cybex dynamometer. The isokinetic cybex dynamometer assessments using angle degree for sense of position.
Assessment of shoulder pain
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.
Assessment of shoulder disability
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.
Assessment of physical health situation
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04434183
First Posted
June 9, 2020
Last Updated
June 16, 2020
Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
1. Study Identification
Unique Protocol Identification Number
NCT04434183
Brief Title
Comparison of the Effects of Home Exercise and Isokinetic Exercise Program in Subacromial Impingement Syndrome Patients
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
May 30, 2018 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Home Exercise, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
isokinetic exercise
Arm Type
Active Comparator
Arm Description
The group (isokinetic exercise group, n = 25) was given isokinetic exercise.
Arm Title
home exercise
Arm Type
Active Comparator
Arm Description
The group(home exercise group, n=25) was given home exercise program.
Intervention Type
Device
Intervention Name(s)
Exercises of rehabilitation
Other Intervention Name(s)
Isokinetic cybex dynamometer
Intervention Description
Compare and evaluate of the effects of the routin physical medicine and rehabilitation programs in impingement patients
Primary Outcome Measure Information:
Title
Assessment of shoulder examination findings
Description
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.
Time Frame
3 months
Title
Assessment of shoulder functions
Description
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.
Time Frame
3 months
Title
Assessment of muscle strenght
Description
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.
Time Frame
3 months
Title
Assessment of quality of life
Description
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.
Time Frame
3 months
Title
Assessment of sense of proprioseption
Description
The investigators evaluated it with isokinetic cybex dynamometer. The isokinetic cybex dynamometer assessments using angle degree for sense of position.
Time Frame
3 months
Title
Assessment of shoulder pain
Description
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.
Time Frame
3 months
Title
Assessment of shoulder disability
Description
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.
Time Frame
3 months
Title
Assessment of physical health situation
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
OMER KURU, FULL PROF
Organizational Affiliation
Prof. Dr. Cemil Tascıoglu City Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Prof Dr Cemil Tascioglu City Hospital
City
Istanbul
ZIP/Postal Code
34384
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
14578662
Citation
Akman S, Kucukkaya M. [Subacromial impingement syndrome: pathogenesis, clinical features, and examination methods]. Acta Orthop Traumatol Turc. 2003;37 Suppl 1:27-34. Turkish.
Results Reference
result
PubMed Identifier
18509791
Citation
Campbell RS, Dunn A. External impingement of the shoulder. Semin Musculoskelet Radiol. 2008 Jun;12(2):107-26. doi: 10.1055/s-2008-1078699.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/14578662/
Description
Subacromial Impingement Syndrome: Pathogenesis, Clinical Features, and Examination Methods
URL
https://pubmed.ncbi.nlm.nih.gov/18509791/?from_single_result=Campbell+RS%2C+Dunn+A%3A+External+impingement+of+the+shoulder.
Description
External Impingement of the Shoulder
Learn more about this trial
Comparison of the Effects of Home Exercise and Isokinetic Exercise Program in Subacromial Impingement Syndrome Patients
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