Comparing the effect of physiotherapy alone and physiotherapy after corticosteroid injection on pain, function, and quality of life in people with shoulder impingement syndrome (A randomized Control Trial)
Comparing the effect of physiotherapy alone and physiotherapy after corticosteroid injection on pain, function, and quality of life in people with shoulder impingement syndrome
Design
Clinical trial, randomized grouping of individuals with sealed envelopes into intervention and control groups, blind assessment of variables by the evaluator
Settings and conduct
Place of study: Physical Therapy Clinic of Ghaem Hospital Evaluator: The other physiotherapist will evaluate the patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: .aged 18-65 years/pain more than 6 weeks/ pain in the upper, outer arm especially when lifting of arm/ signs of shoulder impingement syndrome (presence of three of the following) 1) painful arch movement during flexion or abduction of the shoulder 2) positive Neer or Hawkins-Kennedy test 3) painful resisted external rotation, or painful jobe test
Exclusion criteria: 1.Existence of type 3 acromion 2. Existence of frozen shoulder 3. Existence of neck radiculopathy 4.Existence of Complete rupture of rotator-cuff muscles 5.Existence of shoulder joint instability 6.History of fracture or dislocation or surgery in the shoulder complex 7.Use of Corticosteroids drugs in the last 3 months 8.History of Reflex Sympathetic Dystrophy 9.History of any neurological diseases 10.History of rheumatoid diseases and shoulder osteoarthritis
Intervention groups
Physiotherapy alone
Physiotherapy after corticosteroid injection
Main outcome variables
Pain with VAS scale; functional level with Shoulder pain and disability index and Quick DASH questionnaires; quality of life with WORC questionnaire; effectiveness of treatment with GRC
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201010048980N1
Registration date:2020-11-10, 1399/08/20
Registration timing:registered_while_recruiting
Last update:2020-11-10, 1399/08/20
Update count:0
Registration date
2020-11-10, 1399/08/20
Registrant information
Name
Javad Raeesi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3513 7115
Email address
reisij961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of physiotherapy alone and physiotherapy after corticosteroid injection on pain, function, and quality of life in people with shoulder impingement syndrome (A randomized Control Trial)
Public title
The comparative effect of two methods of rehabilitation in patients with shoulder impingement syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 18-65 years/pain more than 6 weeks/ pain in the upper, outer arm especially when lifting of arm/ signs of shoulder impingement syndrome (presence of three of the following) 1) painful arch movement during flexion or abduction of the shoulder 2) positive Neer or Hawkins-Kennedy test 3) painful resisted external rotation, or painful jobe test
Exclusion criteria:
1.Existence of type 3 acromion 2. Existence of frozen shoulder 3. Existence of neck radiculopathy 4.Existence of Complete rupture of rotator-cuff muscles 5.Existence of shoulder joint instability 6.History of fracture or dislocation or surgery in the shoulder complex 7.Use of Corticosteroids drugs in the last 3 months 8.History of Reflex Sympathetic Dystrophy 9.History of any neurological diseases 10.History of rheumatoid diseases and shoulder osteoarthritis
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Convenient sampling Randomization Tool: Sealed envelopes include paired and odd numbers (from one to 40) allocation concealment will be done randomly.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants choose to pick one of the sealed envelopes. Another physiotherapist who does not know how to group and do the study will evaluate the patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Mashhad University of Medical Sciences
Street address
Opposite University Street 18, University street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2020-09-12, 1399/06/22
Ethics committee reference number
IR.MUMS.REC.1399.432
Health conditions studied
1
Description of health condition studied
Shoulder Impingement Syndrome
ICD-10 code
M75.4
ICD-10 code description
Impingement syndrome of shoulder
Primary outcomes
1
Description
Pain intensity
Timepoint
Before the start of the treatment plan / after the completion of the treatment plan
Method of measurement
Visual analogue scale
Secondary outcomes
1
Description
Disability and functional level
Timepoint
Before the start of the treatment plan / after the completion of the treatment plan
Method of measurement
Quick-DASH questionnaire , SPADI questionnaire
2
Description
The quality of life
Timepoint
Before the start of the treatment plan / after the completion of the treatment plan
Method of measurement
Western Ontario Rotator Cuff Index Questionnaire (WORK)
3
Description
The effectiveness of the treatment
Timepoint
Before the start of the treatment plan / after the completion of the treatment plan
Method of measurement
Global Rating of Change scale (GRC) questionnaire
Intervention groups
1
Description
Intervention group: For patients, corticosteroids are injected first and after 2 to 4 days, a physiotherapy treatment program will be performed in twelve sessions, within one month. This rehabilitation program includes: correcting the body posture, strengthening the rotator cuff muscles, strengthening the muscles of the scapula, and retraining the muscles of the scapula and shoulders
Category
Rehabilitation
2
Description
Control group: One-month physical therapy program for twelve sessions. This rehabilitation program includes: correcting the body posture, strengthening the rotator cuff muscles, strengthening the muscles of the scapula, and retraining the muscles of the scapula and shoulders
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Physical Therapy Clinic of Ghaem Hospital
Full name of responsible person
Mr Javad Zarandi
Street address
Nursing door entrance, right side, library side, Narjes building, first floor,Physiotherapy Department, Ghaem Hospital,
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3841 1538
Email
ZarandiMJ1@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Doctora Cross road, Ghoreshi Building
City
Mashhad
Province
Razavi Khorasan
Postal code
9919191778
Phone
+98 51 3841 1538
Fax
+98 51 3843 0249
Email
vcresearch@mums.ac.ir
Web page address
http://v-research.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
SeyedJavad Raeesi
Position
MSc Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Azadi Square, East door of Ferdowsi University of Mashhad, University campus, Faculty of Paramedical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3513 7115
Email
raeesij@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
SeyedJavad Raeesi
Position
MSc Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Azadi Square, East door of Ferdowsi University of Mashhad, University campus, Faculty of Paramedical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3513 7115
Email
raeesij@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
SeyedJavad Raeesi
Position
MSc Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Azadi Square, East door of Ferdowsi University of Mashhad, University campus- Faculty of Paramedical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3513 7115
Email
raeesij@yahoo.com
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
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
Title and more details about the data/document
All reports will be reported in one research paper. Raw data will be delivered to researchers for meta analysis.
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
For researchers
Under which criteria data/document could be used
Only for meta-analysis
From where data/document is obtainable
raeesij@yahoo.com
What processes are involved for a request to access data/document
The response will be sent within 3 months after considering the researcher's request.