- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04538690
The Effect of Exercise Therapy in Painful Shoulder Disorders
October 13, 2020 updated by: gizem ergezen, Istanbul Medipol University Hospital
The Effect of Exercise Therapy on Balance and Pain in Painful Shoulder Disorders
20 adults who applied to the orthopedic clinic with shoulder pain, did not require surgical intervention, were referred to the physiotherapy clinic for treatment; will be evaluated in terms of balance, pain and joint range of motion and then included in the exercise program.
20 adults without pain will be evaluated as the control group and the results will be compared within and between groups.
Our hypothesis is that the balance will improve and pain will decrease in individuals after exercise.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
20 adults who applied to the orthopedic clinic with shoulder pain, did not require surgical intervention, were referred to the physiotherapy clinic for treatment; will be evaluated in terms of balance, pain and joint range of motion and then included in the exercise program.
20 adults without pain will be evaluated as the control group and the results will be compared within and between groups.
Exercises will be applied 3 days a week for 4 weeks, 45-55 minutes by a physiotherapist within the framework of shoulder rehabilitation.
In addition, balance exercises will not be given.
Balance measurements will be made by the Biodex Balance System, which provides objective data.
Study Type
Interventional
Enrollment (Anticipated)
40
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
-
-
Beykoz
-
Istanbul, Beykoz, Turkey, 34815
- Recruiting
- Istanbul Medipol University
-
Contact:
- Gizem Ergezen, MSc
- Phone Number: 2520 4448544
- Email: gergezen@hotmail.com
-
Principal Investigator:
- Gizem Ergezen, MSc
-
Principal Investigator:
- Mustafa Sahin, MD
-
-
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
20 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Having one of the diagnoses of impingement, rotator cuff syndrome, frozen shoulder, biceps tendon,
- Pain severity felt by the patient above-8 according to the Visual Analogue Scale divided into 10 equal intervals,
- Patients who were recommended conservative treatment
Exclusion Criteria:
- Any previous surgical operation,
- Skeletal system fractures or dislocations,
- Other diagnosed orthopedic, neurological or rheumatological diseases, diabetes, neuropathy and pregnancy
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: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
Age and sex matched non interventional, healthy control group
|
|
|
Experimental: Exercise Group
Individuals who are taken part of shoulder exercises with painful shoulder disorders.
|
Exercises consist of shoulder range of motion, releasing exercises, strength training, stretching.
TENS, US
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Objective Balance Measurement
Time Frame: 4 week
|
By Biodex Balance System Stability and Fall Risk, static and dynamic
|
4 week
|
|
Pain Intensity
Time Frame: 4 week
|
By Visual Analogue Scale scored between 0-10.
0 means no pain and 10 means unbearable pain.
|
4 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range of Motion
Time Frame: 4 week
|
By Goniometer shoulder range of motion will be measured
|
4 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
September 15, 2020
Primary Completion (Anticipated)
November 15, 2020
Study Completion (Anticipated)
November 20, 2020
Study Registration Dates
First Submitted
August 31, 2020
First Submitted That Met QC Criteria
August 31, 2020
First Posted (Actual)
September 4, 2020
Study Record Updates
Last Update Posted (Actual)
October 14, 2020
Last Update Submitted That Met QC Criteria
October 13, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10840098-722.02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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