: Effects of Acromioclavicular joint mobilization on symptoms and functional disability in patients with Frozen Shoulder Syndrome: A randomized controlled trial
Determination of acromiocalvicular joint mobilization effects on symptoms and function of patients with frozen shoulder.
Design
A single blinded randomized controlled clinical trial of 56 patient with frozen shoulder.
Settings and conduct
Target population are all people who presenting with frozen shoulder at specialized physical medicine and rehabilitation clinics of Tabriz university of medical sciences . They will be enroled in the study if they have included criteria and have not excluded criteria. The patients will divide randomly into2 groups (A,B) by computerized randomization with Excel software.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age between 18 to 60 years
Unilateral frozen shoulder
Normal shoulder Xray and normal neurological examination
At least two months passing from the onset of symptoms
؛
exclusion criteria:
Inflammatory or infectious shoulder joint disease
Poor controlled diabetes
Neoplastic disorder of shoulder region
A recent history of fracture, dislocation ,subluxation ,steroid injection or surgery of shoulder complex
Intervention groups
In experimental group, Acromioclavicular joint mobilization techniques will be performed in the form of passive accessory inferior ,posterior to anterior & anterior to posterior glides( grade 3 &4) up to 6 sessions they also will receive physiotherapy and exercise such as control group.
control group will receive 10 sessions of shoulder physiotherapy three times a week with range of motion,stretching and isometric strengthening exercises of shoulder muscles at home twice a day for twenty days .
Main outcome variables
Shoulder range of motion
Functional disability
Pain severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100605004104N7
Registration date:2019-01-06, 1397/10/16
Registration timing:registered_while_recruiting
Last update:2019-01-06, 1397/10/16
Update count:0
Registration date
2019-01-06, 1397/10/16
Registrant information
Name
Mohammad Rahbar
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1544 6694
Email address
rahbarm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
: Effects of Acromioclavicular joint mobilization on symptoms and functional disability in patients with Frozen Shoulder Syndrome: A randomized controlled trial
Public title
Effects of Acromioclavicular joint mobilization in Frozen Shoulder Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 to 60 years
Unilateral frozen shoulder
Normal shoulder Xray and normal neurological examination
At least two months passing from the onset of symptoms
Exclusion criteria:
Inflammatory or infectious shoulder joint disease
Neurological deficit such as stroke which is due to shoulder muscle dysfunction
Poor controlled diabetes
Neoplastic disorder of shoulder region
A recent history of fracture, dislocation or subluxation of shoulder complex
A history of steroid injection of glenohumeral joint, subdeltoid burse or acromiocalvicular joint within the previous 6 months or surgery
A feeling of instability at the glenohumeral joint
Shoulder pain referred from the severe cervical radiculopathy.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will divide randomly into2 groups (A,B) by computerized randomization with Excel software and this sequence will be written in separate envelopes and then will be placed in a box. The patients will treat with sequence of this box.
Blinding (investigator's opinion)
Single blinded
Blinding description
For concealment of allocation and we will write sequence (A,B) based on computerized randomization in separate pockets and will be placed in a box. The patients will treat with sequence of this box. No researcher and statistical analyst will be aware of the type of intervention received.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Tabriz Univercity of Medicine
Street address
Golgasht Street, Central Department no.2, Vice Chancellor for Research, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Approval date
2018-11-19, 1397/08/28
Ethics committee reference number
IR.TBZMED.REC.1397.671
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
Ability to manage in everyday life
Timepoint
before treatment, immediately after treatment.
Method of measurement
Shoulder Pain and Disability Index Questionnaire
2
Description
Range of motion of shoulder joints
Timepoint
before treatment and immediately after treatment.
Method of measurement
Goniometer
3
Description
Pain severity
Timepoint
Before treatment, immediately after treatment
Method of measurement
Visual Analogue Scale with grading from zero to 10 centimeters.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Acromioclavicular joint mobilization techniques will be performed in the form of passive accessory inferior ,posterior to anterior & anterior to posterior glides( grade 3 &4) ,of the distal end of the clavicle in physiological position for up to 6 sessions in the course of therapy by one expert therapist. patients also will receive physiotherapy and exercise such as control group.
Category
Treatment - Other
2
Description
Control group: They will receive 10 sessions of shoulder physiotherapy three times a week with range of motion,stretching and isometric strengthening exercises of shoulder muscles at home twice a day for twenty days that will be conducted in a pain free manner. physiotherapy includes: hot pack for 20 minutes with heat of 74.5 degrees Celsius. Electrical nerve stimulation with frequencies of 70 to 80 hertz for 25 minutes. Continuous ultrasonography with dose of 1.25 to 1.5 w/cm2, and range of motion and stretching exercise .
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza University Hospital
Full name of responsible person
Dr. Mohammad Rahbar
Street address
Golgasht Ave., Imam Reza university hospital, physical medicine and rehabilitation ward
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Email
rahbarm@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Neda Dolatkhah
Street address
Golghasht Ave., Imam Reza hospital, Physical medicine and rehabilitation department.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Email
dolatkhahn@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical 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
Tabriz University of Medical Sciences
Full name of responsible person
Sepideh Ranjbar
Position
Physical medicine and rehabilitation resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Golghasht Ave., Imam Reza hospital, Physical medicine and rehabilitation department
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 1928
Email
Sepideh_R_k@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Mohammad Rahbar
Position
Assistant professor of Physical medicine & rehabilitation
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Golghasht Ave., Imam Reza hospital, Department of Physical Medicine and Rehabilitation
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 33361928
Email
rahbarm@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
sepideh Ranjbar
Position
Physical medicine & rehabilitation resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Golgasht Ave., Imam Reza hospital, deparment of physical medicine and rehabilitation
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 1928
Email
sepideh_r_k@yahoo.com
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