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Efficiency of Hypervolt Device Application in the Treatment of Shoulder Impingement Syndrome

Primary Purpose

Shoulder Impingement

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Physiotherapy
Hypervolt Device
Sponsored by
Uskudar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Impingement

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Uskudar universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control

Massage

Arm Description

classical physiotherapy protocol will be applied.

In addition to the classical physiotherapy protocol, a Hypervolt Device will be applied.

Outcomes

Primary Outcome Measures

Disabilities of the Arm, Shoulder and Hand Questionnaire
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.
Lawton Activities of Daily Living Scale
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".

Secondary Outcome Measures

Full Information

First Posted
August 17, 2023
Last Updated
September 1, 2023
Sponsor
Uskudar University
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1. Study Identification

Unique Protocol Identification Number
NCT06006351
Brief Title
Efficiency of Hypervolt Device Application in the Treatment of Shoulder Impingement Syndrome
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uskudar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Impingement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Exercise therapy and Applying a Hypervolt massager
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
Active Comparator
Arm Description
classical physiotherapy protocol will be applied.
Arm Title
Massage
Arm Type
Experimental
Arm Description
In addition to the classical physiotherapy protocol, a Hypervolt Device will be applied.
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Intervention Description
manual therapy stretching exercises strengthening exercises electrotherapy applications
Intervention Type
Other
Intervention Name(s)
Hypervolt Device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disabilities of the Arm, Shoulder and Hand Questionnaire
Description
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.
Time Frame
12 weeks
Title
Lawton Activities of Daily Living Scale
Description
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".
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ömer şevgin
Phone
+90506 978 75 35
Email
omer.sevgin@uskudar.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tuba KARACA
Organizational Affiliation
Uskudar University
Official's Role
Study Chair
Facility Information:
Facility Name
Uskudar university
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ömer Şevgin
Email
omer.sevgin@uskudar.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30774463
Citation
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.
Results Reference
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PubMed Identifier
20371557
Citation
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.
Results Reference
background
PubMed Identifier
28027039
Citation
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.
Results Reference
background
PubMed Identifier
24217037
Citation
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.
Results Reference
background
PubMed Identifier
28630217
Citation
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.
Results Reference
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Efficiency of Hypervolt Device Application in the Treatment of Shoulder Impingement Syndrome

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