- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06006351
Efficiency of Hypervolt Device Application in the Treatment of Shoulder Impingement Syndrome
December 21, 2023 updated by: Dr. Öğr. Üyesi Ömer Şevgin, Uskudar University
Comparison of the Effects of Exercise and Hypervolt Device Application on Pain, Muscle Strength and Normal Joint Movement in the Treatment of Shoulder Impingement Syndrome
The aim of this study is to compare the effects of exercise and Hypervolt Device on pain, muscle strength and normal joint movement in the treatment of shoulder impingement syndrome.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study was planned as a randomized controlled trial.
The study sample will be divided into two groups by simple randomization method.
Only exercise will be applied to 30 individuals diagnosed with shoulder impingement in the first group of the study.
In the second group, 30 individuals with shoulder impingement diagnosis will be given a Hypervolt Device in addition to the exercise.
Disabilities of the Arm, Shoulder and Hand Questionnaire, Visual Analog Scale and Lawton Daily Living Activities Questionnaire will be applied to the participants before and after the treatment.
The obtained data will be analyzed statistically.
Study Type
Interventional
Enrollment (Actual)
30
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 Contact
- Name: Ömer ŞEVGİN
- Phone Number: +90506 978 75 35
- Email: omer.sevgin@uskudar.edu.tr
Study Locations
-
-
-
Istanbul, Turkey
- Uskudar University
-
-
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
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Being between the ages of 18-50.
- Having a Visual Analogue Scale (VAS) value of 5 or higher.
- Having a history of shoulder pain for at least 1 month.
- Volunteer to participate in research.
- Having been diagnosed with Shoulder Impingement.
Exclusion Criteria:
- Having cognitive, mental or psychological problems.
- Having a condition that prevents him from exercising.
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: control
classical physiotherapy protocol will be applied.
|
manual therapy stretching exercises strengthening exercises electrotherapy applications
|
Experimental: Massage
In addition to the classical physiotherapy protocol, a Hypervolt Device will be applied.
|
manual therapy stretching exercises strengthening exercises electrotherapy applications
The painful area will be applied with a massage tool, and the frequency and mode of the tool will be adjusted in a way that does not disturb the patient.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disabilities of the Arm, Shoulder and Hand Questionnaire
Time Frame: 12 weeks
|
It was developed to evaluate functional status and symptoms by focusing on physical function in upper extremity injuries.
According to the results of the survey; a result from 0-100 is obtained from each part; 0-no apology 100-maximum apology.
|
12 weeks
|
Lawton Activities of Daily Living Scale
Time Frame: 12 weeks
|
It is a questionnaire consisting of eight questions, including information about using the telephone, preparing food, shopping, doing daily household chores, washing clothes, getting on a transportation vehicle, using medicines and managing money.
If the individual does the activities independently, three points, two points if he does it with help, and one point if he cannot do it at all.
In Lawton Activities of Daily Living Scale; 0-8 points are classified as "dependent", 9-16 points as "semi-dependent", 17-24 points as "independent".
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Tuba KARACA, Uskudar University
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
- Steuri R, Sattelmayer M, Elsig S, Kolly C, Tal A, Taeymans J, Hilfiker R. Effectiveness of conservative interventions including exercise, manual therapy and medical management in adults with shoulder impingement: a systematic review and meta-analysis of RCTs. Br J Sports Med. 2017 Sep;51(18):1340-1347. doi: 10.1136/bjsports-2016-096515. Epub 2017 Jun 19.
- Consigliere P, Haddo O, Levy O, Sforza G. Subacromial impingement syndrome: management challenges. Orthop Res Rev. 2018 Oct 23;10:83-91. doi: 10.2147/ORR.S157864. eCollection 2018.
- Ellenbecker TS, Cools A. Rehabilitation of shoulder impingement syndrome and rotator cuff injuries: an evidence-based review. Br J Sports Med. 2010 Apr;44(5):319-27. doi: 10.1136/bjsm.2009.058875.
- Marik TL, Roll SC. Effectiveness of Occupational Therapy Interventions for Musculoskeletal Shoulder Conditions: A Systematic Review. Am J Occup Ther. 2017 Jan/Feb;71(1):7101180020p1-7101180020p11. doi: 10.5014/ajot.2017.023127.
- Gebremariam L, Hay EM, van der Sande R, Rinkel WD, Koes BW, Huisstede BM. Subacromial impingement syndrome--effectiveness of physiotherapy and manual therapy. Br J Sports Med. 2014 Aug;48(16):1202-8. doi: 10.1136/bjsports-2012-091802. Epub 2013 Nov 11.
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 1, 2023
Primary Completion (Actual)
December 1, 2023
Study Completion (Actual)
December 1, 2023
Study Registration Dates
First Submitted
August 17, 2023
First Submitted That Met QC Criteria
August 17, 2023
First Posted (Actual)
August 23, 2023
Study Record Updates
Last Update Posted (Actual)
December 22, 2023
Last Update Submitted That Met QC Criteria
December 21, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Uskudar54
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
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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