The short term Effect of Physiotherapy and Intraarticular Corticosteroid Injection on Pain, Disability, and Effectiveness of Treatment in Patients with Frozen Shoulder: Randomized Controlled Trial
The purpose of this study was to compare of the short term effect of Physiotherapy and Intraarticular Corticosteroid Injection on Pain, Disability and effectiveness of Treatment in patients with Frozen shoulder.
Design
Using stratified randomization, two indexes of numbers 1 and 2, which belong to physiotherapy (number 1) and injection (number 2), respectively, will be generated and put into opaque, sealed envelopes. one group of envelopes belongs to diabetic patients and the other group, to non diabetic patients. Based on the mean and standard deviation of the SPADI questionnaire score in similar Studies, 24 subjects in each group, with a 10% drop, are considered.
Settings and conduct
Special Physiotherapy clinic of Qaem Hospital
Orthopedics clinic of Imam Reza hospital
Orthopedics clinic of Dr. Ali Moradi
Participants/Inclusion and exclusion criteria
After evaluation and assessing the inclusion and exclusion criteria, patients diagnosed with Frozen Shoulder will be allocated randomly into two groups of Injection and Physiotherapy.
Intervention groups
In physiotherapy group, who will receive 10 Therapeutic sessions, 3 sessions weekly, after hot pack application for 15 minutes, low level laser will be applied for 30 seconds in 8 painful points of the glenohumeral capsule with an energy amount of 1.8 joules per each point. Afterwards, a grade 2 glenohumeral mobilization for Abduction and External Rotation will be applied. Finally, the D2 flexion pattern of the involved extremity accompanied by Hold Relax technique, performed with 10 seconds of antagonist muscle contraction, will be applied 5 times per each session. In injection group, 20 milligrams of Triamcinolone, half with the posterior glenohumeral approach (1.5 milliliters) and the other half with lateral subacromial approach, will be injected.
Main outcome variables
1. VAS
2. SPADI questionnaire
3. GRC scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161221031506N8
Registration date:2022-03-21, 1401/01/01
Registration timing:prospective
Last update:2022-03-21, 1401/01/01
Update count:1
Registration date
2022-03-21, 1401/01/01
Registrant information
Name
Salman Nazary-Moghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3884 6713
Email address
nazaryms@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-04, 1401/01/15
Expected recruitment end date
2023-03-16, 1401/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The short term Effect of Physiotherapy and Intraarticular Corticosteroid Injection on Pain, Disability, and Effectiveness of Treatment in Patients with Frozen Shoulder: Randomized Controlled Trial
Public title
Comparison of Drug Injection and Physiotherapy in patients diagnosed with Frozen Shoulder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients older than 18 years
Abduction and External rotation limitation (More than 50%)
History of at least 4 weeks of Shoulder pain
Absence of coagulative diseases
Sleep disturbances due to pain
Exclusion criteria:
History of severe trauma to the shoulder
History of neck radiculopathy
History of complete Rotator Cuff tear
Severe infection
History of Glenohumeral joint fracture
Presence of malignancy in Shoulder
4 to 6 months after Radiotherapy in Shoulder
Injection contraindications (Allergic to Drug, etc.)
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will choose from sealed, opaque envelopes.
Another physiotherapist who is not aware of the allocation will evaluate the patients.
Blinding (investigator's opinion)
Single blinded
Blinding description
Assessing the outcome will be performed by another practitioner who is unaware of the allocation process. Statistical analyzer will be blinded for data analysis.
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
Across University Street 18, University Street.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2022-02-26, 1400/12/07
Ethics committee reference number
IR.MUMS.REC.1400.345
Health conditions studied
1
Description of health condition studied
Adhesive capsulitis of shoulder
ICD-10 code
M75.0
ICD-10 code description
Adhesive capsulitis of shoulder
Primary outcomes
1
Description
Pain
Timepoint
Immediately After Allocation, 6 weeks after Randomization
Method of measurement
Visual Analog Scale
2
Description
Disability
Timepoint
Immediately After Allocation, 6 weeks after Randomization
Method of measurement
SPADI questionnaire
3
Description
The Effectiveness of Treatment
Timepoint
6 weeks after randomization
Method of measurement
Global Rating Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In physiotherapy group, who will receive 10 Therapeutic sessions, 3 sessions weekly, after hot pack application for 15 minutes, low level laser will be applied for 30 seconds in 8 painful points of the glenohumeral capsule with an energy amount of 1.8 joules per each point. Afterwards, a grade 2 glenohumeral mobilization for Abduction and External Rotation will be applied. Finally, the D2 flexion pattern of the involved extremity accompanied by Hold Relax technique, performed with 10 seconds of antagonist muscle contraction, will be applied 5 times per each session
Category
Rehabilitation
2
Description
Control group: 20 milligrams of Triamcinolone, half with the posterior glenohumeral approach (1.5 milliliters) and the other half with lateral subacromial approach, will be injected.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Physical Therapy Clinic of Qaem 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 Majid Ghayour Mobarhan
Street address
Doctora Cross road, Ghoreshi Building
City
Mashhad
Province
Razavi Khorasan
Postal code
9919191778
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Personal Grant (Dr Salman Nazary-Moghadam)
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
Mohammad Ali Zare
Position
MSc Colleague
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Paramedical Sciences, University campus, East entrance of Ferdowsi University of Mashhad, Azadi Square, Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3869 8719
Email
Mohammadalizare6@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Ali Zare
Position
MSc Colleague
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Paramedical Sciences, University campus, East entrance of Ferdowsi University of Mashhad, Azadi Square, Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3869 8719
Email
mohammadalizare6@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Ali Zare
Position
MSc Colleague
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Paramedical Sciences, University campus, East entrance of Ferdowsi University of Mashhad, Azadi Square, Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3869 8719
Email
mohammadalizare6@gmail.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
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 data will be reported in the form of a research article. Raw data will be delivered to researchers for meta analysis.
When the data will become available and for how long
6 months after publication
To whom data/document is available
For researchers only.
Under which criteria data/document could be used
For meta-analysis Only.
From where data/document is obtainable
Nazary_salman@yahoo.com
What processes are involved for a request to access data/document
The response will be sent 3 within months after considering the researcher's request.