Randomized controlled trial to study of efficacy of continuous passive motion device on pain and range of motion in order to improve function, in the patients with shoulder joint stiffness
This is a clinical trial study to improve therapeutic methods and shortening the length of treatment in indivituals with shoulder joint stiffness and Determining the Effectiveness of Using CPM Machine on Pain, Range of Motion and Function of Individuals with Frozen Sholder
Design
In this study, 16 frozen shoulder patients are selected, who have been admitted to the study and come to the referral center. Participants are randomly divided into two groups of intervention and control
Settings and conduct
The statistical population in this study includs all individuals with shoulder joint stiffness in Tehran aged between 40 to 65 years old. Convenience sampling method will be used, then patients randomly will be divided into two groups of standard treatments including usage of CPM device (intervention group) and standard intervention (control group) with a sample size of 8 per group.
Participants/Inclusion and exclusion criteria
The inclusion criteria included individuals with shoulder joint stiffness diagnosed in second stages of disease and at least 3 months passes of the onset of their disease
Intervention groups
Intervention group: A group that uses CPM devices in addition to receiving common exercises treatment.
Control group: A group that only receives common exercises treatment
Main outcome variables
Reduce pain, Increase the range of motion, Improve performance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170719035173N2
Registration date:2018-01-23, 1396/11/03
Registration timing:retrospective
Last update:2018-01-23, 1396/11/03
Update count:0
Registration date
2018-01-23, 1396/11/03
Registrant information
Name
hamideh azizi
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0037
Email address
ha.azizi@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
institution
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2018-01-08, 1396/10/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized controlled trial to study of efficacy of continuous passive motion device on pain and range of motion in order to improve function, in the patients with shoulder joint stiffness
Public title
Efficacy of continuous passive motion device in the shoulder joint stiffness
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of shoulder joint stiffness
Symptoms of stage 2 of disease
Expired at least 3 months from the onset of the disease
Age between 40-65
Exclusion criteria:
Herniation of cervical disks
Joint shoulder stiffness due to neurological disease
Injury during the study
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
16
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are placed in one of the two intervention or control groups using sealed envelopes and receive intervention from the same group.
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
University of Social Welfare and Rehabilitation Sciences
Street address
Daneshjoo Blvd, Evin, Tehran,I ran
City
Tehran
Province
Tehran
Postal code
1985713834
Approval date
2017-06-22, 1396/04/01
Ethics committee reference number
IR.USWR.REC.1396.17
Health conditions studied
1
Description of health condition studied
Frozen Shoulder
ICD-10 code
M75.0
ICD-10 code description
Adhesive capsulitis of shoulder
Primary outcomes
1
Description
Pain
Timepoint
At the initial of the threatment, 4, 6 Weeks
Method of measurement
Visual Analog Scale
Secondary outcomes
1
Description
Shoulder range of motion
Timepoint
The initial of the threatment, 4, 6 weeks
Method of measurement
Goniometery
Intervention groups
1
Description
Intervention: conservative treatment and CPM device
Category
Rehabilitation
2
Description
Control group: conservative treatment
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Asma rehabilitation center
Full name of responsible person
Maryam Farzad
Street address
Corner of Twelve St, Asad Abadi Street, Yousef Abad
City
Tehran
Province
Tehran
Postal code
1985713834
Email
Ha.azizi@uswr.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Department of Occupational Therapy
Street address
Daneshjoo Blvd, Evin, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0037
Email
Ha.azizi@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Social Welfare and Rehabilitation Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Hamideh Azizi
Position
Student of Master of Science of Occupational Therapy
Latest degree
Bachelor
Other areas of specialty/work
Street address
Daneshjoo Blvd, Evin, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
9185713834
Phone
+98 21 2218 0037
Fax
Email
Ha.azizi@uswr.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Maryam Farzad
Position
PHD of Occupational Therapy
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Daneshjoo Blvd, Evin, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
9185713834
Phone
+98 21 2218 0037
Fax
Email
ma.farzad@uswr.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Hamideh Azizi
Position
Student of Master of Occupational Therapy
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Daneshjoo Blvd, Evin, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
9185713834
Phone
+98 21 2218 0037
Fax
Email
Ha.azizi@uswr.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available