Objective:
The aim of the present study is investigation of the effects of a physiotherapy program on surgery candidate patients with full thickness tear of Supraspinatpus tendon on some clinical parameters in Yazd city.
Design:This is a randomized clinical trial.
Setting and conduct: The study population are the patients with total Supraspinatous tear.The patients do the physiotherapy program for 10 weeks (30 sessions), the reassessment of variables will be done after the 20th and 30th sessions.The present study will have 2 main steps; at first a methodological research for reliability will done. At the second step the main clinical trial will done.
Participants including major eligibility criteria:15 patients candidate for surgery due to Supraspinatous rupture with age range between 40 to 70 (years) will be chosen based on below inclusion and exclusion criteria:
Inclusion criteria: Non-traumatic full tear of Supraspinatous tendon according to physician refer; positive sign of impingement; presentation of sign and symptoms for more than 6 months.
These subjects will not include in the study: Any injury of shoulder girdle complex (other than inclusion criteria); Degenerative Joint Diseases or Arthritis of shoulder complex; tendon tear of other muscles (except Supraspinatous tendon); recurrent dislocation of shoulder; fracture and stiffness of shoulder capsule.
Exclusion criteria: If a patient dose not complete the Physiotherapy program; missing the sessions for more than two.
Intervention: A physiotherapy protocol which has 3 basic phases will execute for 10 weeks.
Variables: The main variables are pain based on Visual Analog Scale , function of shoulder based on Quick Dash questioner, active and passive range of motion and shoulder muscles strength.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014081018754N1
Registration date:2014-11-23, 1393/09/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-23, 1393/09/02
Registrant information
Name
Javad Sarrafzadeh
Name of organization / entity
Iran University of Medical Sciences, School of Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
00982122228051-00982122227124
Email address
sarrafzadeh.j@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Tehran University of Medical Sciences
Expected recruitment start date
2014-11-01, 1393/08/10
Expected recruitment end date
2015-04-30, 1394/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of effect of Physiotherapy on some clinical parameters of surgery candidate patients with full thickness tear of Supraspinatpus tendon
Public title
Investigation of effect of Physiotherapy on surgery candidate patients with full thickness tear of Supraspinatpus tendon
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Non-traumatic full tear of Supraspinatous tendon according to physician refer; positive sign of impingement; presentation of sign and symptoms for more than 6 months.
These subjects will not include in the study: Any injury of shoulder girdle complex (other than inclusion criteria); Degenerative Joint Diseases or Arthritis of shoulder complex; tendon tear of other muscles (except Supraspinatous tendon); recurrent dislocation of shoulder; fracture and stiffness of shoulder capsule.
Exclusion criteria: If a patient dose not complete the Physiotherapy program; missing the sessions for more than two.
*The patient will stop his/she program any time he/she wants.
Age
From 40 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Tehran University of Medical Sciences
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2014-01-08, 1392/10/18
Ethics committee reference number
92.130.2342
Health conditions studied
1
Description of health condition studied
Supraspinatus Tear
ICD-10 code
M75.1
ICD-10 code description
Rotator cuff syndrome
Primary outcomes
1
Description
Shoulder Pain
Timepoint
Before the intervention, 20th session and at the end of intervention (30th session)
Method of measurement
VAS
2
Description
Shoulder Function
Timepoint
Before the intervention, 20th session and at the end of intervention (30th session)
Method of measurement
QuickDASH questionnaire
3
Description
Passive and active range of motion of shoulder
Timepoint
Before the intervention, 20th session and at the end of intervention (30th session)
Method of measurement
Goniometer
4
Description
Strength of shoulder muscles
Timepoint
Before the intervention, 20th session and at the end of intervention (30th session)
Method of measurement
Dynamometer
Secondary outcomes
empty
Intervention groups
1
Description
A physiotherapy protocol which included 3 basic phase will execute for all surgery candidate patients who will participate in the present study. Each phase will last for 3 to 4 weeks depend on improvement of the patient. In each phase, the aim is to decrease pain and increase passive and active range of motion and also increasing the shoulder muscles power. Base on determined criteria (such as shoulder pain and range of motion) in each phase, the patient will switch to the next phase.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Yazd Hospital, Yazd University of Medical Sciences