Comparison of the effectiveness of early intra-shoulder injection with receiving only physiotherapy treatment in patients with chronic shoulder pain referred to the orthopedic clinic of Imam Khomeini and Golestan educational centers in Ahvaz
Comparison of the effectiveness of early intra-shoulder injection with receiving only physiotherapy treatment in patients with chronic shoulder pain referred to the orthopedic clinic of Imam Khomeini and Golestan educational centers in Ahvaz in 1400
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
the research is done in golestan and emam khomeini clinical hospital; all diagnosis and examination done in this place.
patient dose not know they belong to which group.
examiner dose not know which group that he exam.
Participants/Inclusion and exclusion criteria
pain duration more than 6 month; no teruma; no surgery; no injection; patient satisfiction; no neurological disease; no shoulder anomaly
Intervention groups
in first group shoulder injection done in moment of diagnosis;
in control group patient goes to physiotherapy without injection
Comparison of the effectiveness of early intra-shoulder injection with receiving only physiotherapy treatment in patients with chronic shoulder pain referred to the orthopedic clinic of Imam Khomeini and Golestan educational centers in Ahvaz
Public title
evaluation of early shoulder injection in chronic shoulder pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
duration of pain more than 6 month
no history of teruma
no history of shoulder surgery
no history of shoulder injection
patient wants to be participated
Exclusion criteria:
age below 18 or more than 65
history of treatment like our treatment
present of systemic inflammatory disease
neurological condition involved upper extermity
allergic reaction or contraindication for corticostiroid
anatomical abnormality in shoulder x ray
if the patient dose not want to be participate
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Investigator
Data analyser
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of patient are done with computed soft war random allocation software that divide patient un tow group by using blocking system, for example every 8 patient belong to each group.
Blinding (investigator's opinion)
Single blinded
Blinding description
ph therapist dose not now about wich patient belong to wich group
practitioner dose not know that the patient belong to which group
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of ahwaz golestan hospital
Street address
No. 3; west 17th street; kian pars blvd
City
ahwaz
Province
Khouzestan
Postal code
6155883464
Approval date
2022-02-13, 1400/11/24
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1400.170
Health conditions studied
1
Description of health condition studied
chronic shoulder pain after adhesive capsulitis; impingment syndrome; sub acromial bursitis; shoulder djd.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
severity of shoulder pain
Timepoint
at time of diagnosis; 6 weeks after initial treatment; 12 weeks after initial treatment
Method of measurement
visual analogue score
Secondary outcomes
empty
Intervention groups
1
Description
Control group: under 16 section of shoulder physiotherapy that include same ph therapist same devices an order is exe us tens ir and emphsizing on agressive rang of motion.
Category
Rehabilitation
2
Description
Intervention group: under 80 ml intra shoulder injection methilpredison from exir co with 5 cc of nacl ; 15 section of shoulder physiotherapy same as another group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
emam khomeini hospital
Full name of responsible person
payam mohammadhoseini
Street address
No.3 , west 17th street, kian pars Blvd
City
ahwaz
Province
Khouzestan
Postal code
6155883464
Phone
+98 61 3337 6686
Email
Mohammadhoseini-p@ajums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
mohamad mohamadi
Street address
No 3, west 17th st, kian pars Blvd
City
ahwaz
Province
Khouzestan
Postal code
6155883464
Phone
+98 61 3337 6686
Email
Mohammadhoseini-p@ajims.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
ahwaz university of medical sciens
Proportion provided by this source
1
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
Ahvaz University of Medical Sciences
Full name of responsible person
payam mohammadhoseini
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
No 3 , west 17th st, kian pars Blvd
City
ahwaz
Province
Khouzestan
Postal code
6155883464
Phone
+98 61 3337 6686
Email
Mohammadhoseini-p@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
payam mohammadhoseini
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
No.3, west 17th st, kian pars Blvd
City
ahwaz
Province
Khouzestan
Postal code
6155883464
Phone
+98 61 3337 6686
Email
Mohammadhoseini-p@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
payam mohammadhoseini
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
No.3, west 17th st, kian pars Blvd
City
ahwaz
Province
Khouzestan
Postal code
6155883464
Phone
+98 61 3337 6686
Email
Mohammadhoseini-p@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
all of data that used in this research
When the data will become available and for how long
one year after publish
To whom data/document is available
for academic practitioner
Under which criteria data/document could be used
use for systemic reveiw research
From where data/document is obtainable
Mohammadhoseini-p@ajums.ac.ir
What processes are involved for a request to access data/document