Protocol summary

Summary
All examinations performed on patients with shoulder overuse syndrome to recognize for their inclusion criteria to participate in the study. A signed consent for participation in the study also was obtained from the attending subjects, who will be treated for shoulder pain/dysfunction. Before the intervention, pain intensity, posture, muscle strength and flexibility of movement of patients are evaluated. Pain is measured using the VAS. Scapular position and rotation are measured ,in first evaluation, shoulder protraction will be measured using the tape and formulas and in other methods scapular lateral slide test condition is evaluated. Also , Shoulder posture is measured by the distance of acromion process distance to the wall patient is standing in front of it, by a special ruler, double square ( millimeter ). Mid thoracic curve will be measured with a flexible ruler (Flexi ruler) between T2 and T12 curvature and degree of the curve is calculated with the corresponding formula. For head posture , the angle between the horizontal line that passes through C7 and the second line of the C7 spinous process to ear TRAGO is measured by a protractor. Isometric muscle strength by hand held dynameter is evalutaed. During muscle Pectoralis minor length is measured with two methods of assessment , the first method, posterolateral aspect of acromion process to the bed edge in which patient lying on it is measured and in the second method the distance between the two anatomical landmark, the angle of internal inferior (medial-inferior ) Coracoid process to the junction of the fourth rib to the sternum is measured with a caliper (Vernier calliper). The range of shoulder abduction and external rotation by Goniometer ( Kendall method ) is evaluated. There are two groups in this study [ Exercise Therapy ( I ) Group and Physical Therapy( II ) Group ], Exercise group receive a exercises program includes strengthening , stretching and Scapular Stabilization exercise. Group II, Physical Therapy (PT) who receive a conventional electrotherapy consisted of Conventional TENS and Ultrasound for 18 sessions (three sessions per week for 6 weeks). Eventually results in the both groups on pain, posture, muscle strength, flexibility, shoulder range of motion of patients will be evaluated and compared.

General information

Acronym
Exercise therapy & Physical modalities in shoulder overuse syndrom
IRCT registration information
IRCT registration number: IRCT201111025486N2
Registration date: 2012-01-17, 1390/10/27
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-01-17, 1390/10/27
Registrant information
Name
Azar Moezy
Name of organization / entity
Iran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2446
Email address
moeziazr@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-01-01, 1390/10/11
Expected recruitment end date
2013-01-10, 1391/10/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of exercise therapy and physiotherapy in improving shoulder pain, posture, muscle strength, flexibility and range of motion in patients with shoulder overuse syndrome
Public title
A comparative study of exercise therapy and physiotherapy in improving shoulder pain, posture, muscle strength, flexibility and range of motion in patients with shoulder overuse syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: unilateral or bilateral shoulder overuse syndrome based on patient’s history & physical exams; age between 20 to50; normal mental state; no previous history of trauma & acute injury; no previous history of shoulder surgery; no previous history of shoulder dislocation and no previous history of shoulder or arm fractures. Exclusion criteria: patient’s unwilling to continue the study; diseases that impede patient to be attended in the study and absence in treatment sessions
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committe of vice chancellor for research , TUMS
Street address
Keshvarz Blvd
City
Tehran
Postal code
1449614525
Approval date
2011-12-19, 1390/09/28
Ethics committee reference number
1992 / 130 / ص/90

Health conditions studied

1

Description of health condition studied
Shoulder overuse syndrom
ICD-10 code
M75.4
ICD-10 code description
Impingement syndrome of shoulder

Primary outcomes

1

Description
Pain
Timepoint
Before intervention and six weeks after intervention
Method of measurement
Pain scale (VAS)

2

Description
Pectoralis minor length
Timepoint
Before intervention and six weeks after intervention
Method of measurement
Pectoralis minor length measurments

3

Description
Shoulder Range of Motion
Timepoint
Before intervention and six weeks after intervention
Method of measurement
Goniometric measurement of shoulder Abduction and External rotation

4

Description
Posture
Timepoint
Before intervention and six weeks after intervention
Method of measurement
Head, midthoracic, shoulder posture with measurement and calculations

Secondary outcomes

empty

Intervention groups

1

Description
Intervention for group II or physical therapy group consist of three days a week physical therapy during which the subjects treated with conventional TENS and ultrasound for 18 sessions (three sessions per week for 6 weeks) .
Category
Rehabilitation

2

Description
Exercise Therapy Group intervention : The exercise program will be done three days a week for 6 weeks. The exercise program is included strengthening exercise, stretching ,proprioceptive and scapular stabilization exercise with swiss ball and Therabands.After 20 to 30 minute warm-up exercises will begin . In training sessions, a series of stretching e xercises for the anterior muscles of the chest muscles and internal rotators of the shoulders are included.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Sport Medicine evaluation center - Hazrateh Rasul Akram Hospital
Full name of responsible person
Dr Saeed Sepehrifar
Street address
Niyaesh street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran Unversity of Medical Sceinces - Vice Chancellor for Research
Full name of responsible person
Ms Alamdar
Street address
Keshvarz blvd.
City
Tehran
Grant name
معاونت پژوهشی دانشگاه علوم پزشکی تهران
Grant code / Reference number
90-01-30-13144
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran Unversity of Medical Sceinces - Vice Chancellor for Research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Azar Moezy
Position
PhD
Other areas of specialty/work
Street address
Heamt Highway-Medicine school-Sports Medicine Deparment
City
Tehran
Postal code
Phone
+98 21 8294 3424
Fax
Email
moeziazr@sina.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Teharn Unversity of Medical sciences
Full name of responsible person
Dr Azar Moezy
Position
PhD
Other areas of specialty/work
Street address
Hemat Highway, Medicine School, Sports medicine department
City
Tehran
Postal code
Phone
+98 21 8294 3424
Fax
Email
moeziazr@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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