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The Effect of Exercise Therapy in Painful Shoulder Disorders

Primary Purpose

Shoulder Pain, Shoulder Disease, Balance; Distorted

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Shoulder Exercises
Electrotherapy
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul Medipol UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Exercise Group

Arm Description

Age and sex matched non interventional, healthy control group

Individuals who are taken part of shoulder exercises with painful shoulder disorders.

Outcomes

Primary Outcome Measures

Objective Balance Measurement
By Biodex Balance System Stability and Fall Risk, static and dynamic
Pain Intensity
By Visual Analogue Scale scored between 0-10. 0 means no pain and 10 means unbearable pain.

Secondary Outcome Measures

Range of Motion
By Goniometer shoulder range of motion will be measured

Full Information

First Posted
August 31, 2020
Last Updated
October 13, 2020
Sponsor
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04538690
Brief Title
The Effect of Exercise Therapy in Painful Shoulder Disorders
Official Title
The Effect of Exercise Therapy on Balance and Pain in Painful Shoulder Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
November 15, 2020 (Anticipated)
Study Completion Date
November 20, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain, Shoulder Disease, Balance; Distorted, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Age and sex matched non interventional, healthy control group
Arm Title
Exercise Group
Arm Type
Experimental
Arm Description
Individuals who are taken part of shoulder exercises with painful shoulder disorders.
Intervention Type
Other
Intervention Name(s)
Shoulder Exercises
Intervention Description
Exercises consist of shoulder range of motion, releasing exercises, strength training, stretching.
Intervention Type
Other
Intervention Name(s)
Electrotherapy
Intervention Description
TENS, US
Primary Outcome Measure Information:
Title
Objective Balance Measurement
Description
By Biodex Balance System Stability and Fall Risk, static and dynamic
Time Frame
4 week
Title
Pain Intensity
Description
By Visual Analogue Scale scored between 0-10. 0 means no pain and 10 means unbearable pain.
Time Frame
4 week
Secondary Outcome Measure Information:
Title
Range of Motion
Description
By Goniometer shoulder range of motion will be measured
Time Frame
4 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gizem Ergezen
Phone
+905347098414
Email
gergezen@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gizem Ergezen, MSc
Organizational Affiliation
Medipol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Medipol University
City
Istanbul
State/Province
Beykoz
ZIP/Postal Code
34815
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gizem Ergezen, MSc
Phone
4448544
Ext
2520
Email
gergezen@hotmail.com
First Name & Middle Initial & Last Name & Degree
Gizem Ergezen, MSc
First Name & Middle Initial & Last Name & Degree
Mustafa Sahin, MD

12. IPD Sharing Statement

Learn more about this trial

The Effect of Exercise Therapy in Painful Shoulder Disorders

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