Examining the separate and combined effects of physiotherapy treatment and corticosteroid injection on range of motion and pain in patients with full tickness rotator cuff tear referring to the specialized clinic in Dezfull city.
Determining the separate and combined effects of physiotherapy and corticosteroid injection on range of motion and pain in patients full tickness rotator cuff tear
Design
A clinical trial with control group, with parallel groups, randomized
Settings and conduct
96 patients are sampled in a randomized block method. After giving some explanations about the plan and research steps to the patients and obtaining consent, they are divided into 3 groups of 33 people. First, DASH questionnaire and VAS criterion will be completed by these three groups and the motor function of them will be measured by goniometer. The first group will receive physiotherapy, the second group will receive corticosteroid injection and the third group will receive physiotherapy and corticosteroid injection. At the end of intervention, pain and motor function of the patients will be examined by DASH questionnaire and VAS criterion and are measured by goniometer by rehabilitation specialist and orthopaedic physician established in Dezful city and by medical student. At the end of the study, the data results before and after the intervention of these 3 groups will be compared.
Participants/Inclusion and exclusion criteria
Patients with degenerative rotator cuff tear confirmed by MRI and clinical examination, are excluded from the study if they are older than 70 years, with metastasis or cancer, with concurrent shoulder disease such as infection, fracture and tumour, Non-cooperation of the patients, impaired consciousness in patients, severe cervical radiculopathy, therapeutic intervention by the persons not presenting in the plan, trauma during treatment, contraindication of corticosteroid injection.
Intervention groups
Patients with complete degenerative rotator cuff tear referring to the specialized clinic in Dezfull city
Main outcome variables
pain_ Shoulder ROM
General information
Reason for update
Acronym
CSI
IRCT registration information
IRCT registration number:IRCT20200102045987N1
Registration date:2020-03-03, 1398/12/13
Registration timing:registered_while_recruiting
Last update:2020-03-03, 1398/12/13
Update count:0
Registration date
2020-03-03, 1398/12/13
Registrant information
Name
Atousa Dachek
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4264 0419
Email address
atousadachek@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Examining the separate and combined effects of physiotherapy treatment and corticosteroid injection on range of motion and pain in patients with full tickness rotator cuff tear referring to the specialized clinic in Dezfull city.
Public title
Examining the separate and combined effects of physiotherapy treatment and corticosteroid injection on range of motion and pain in patients with full tickness rotator cuff tear.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with degenerative rotator cuff tear confirmed by MRI and clinical examination.
30_70 years old
No metastasis or cancer
No concurrent shoulder disease like fracture and infection
Patient collaborations and having informed consent
No severe cervical radiculopathy
Full consciousness
No therapeutic intervention by the persons not presenting in the plan
No trauma during treatment
No contraindication of corticosteroid injection like sensitivity to these drugs and symptoms of skin infection at the injection site
Exclusion criteria:
Over than 70 years old
Existence of Metastasis or cancer
Existence of concurrent shoulder disease such as infection, fracture and tumor
Non-cooperation of the patients
Impaired consciousness in patients
Existence of severe cervical radiculopathy
Therapeutic intervention by the persons not presenting in the plan
Trauma during treatment
Contraindications of corticosteroid injection such as sensitivity to these drugs and symptoms of skin infection at the injection site
Tears caused by acute trauma
Age
From 30 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
96 patients are sampled in a randomized block method. They are divided into 3 groups of 33 individuals, as it were, all subset items are calculated based on the 6-person blocks (AABBCC) and they are assigned to each Intervention groups according to the patients’ random blocking.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of dezful University of Medical Sciences
Street address
No.37, payervan Ave., Andimeshk Town
City
Andimeshk
Province
Khouzestan
Postal code
6484113532
Approval date
2019-12-28, 1398/10/07
Ethics committee reference number
IR.DUMS.REC.1398.045
Health conditions studied
1
Description of health condition studied
Examining the separate and combined effects of physiotherapy treatment and corticosteroid injection on range of motion and pain in patients with full tickness thickness rotator cuff tear
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain score of patients on the criterion VAS(Visual analoge scale)
Timepoint
The shoulder ROM in patients at the beginning of the study (before intervention) and at the end of physiotherapy sessions and one month after the last physiotherapy session
Method of measurement
Questionnaire DASH
2
Description
Shoulder Range of motion
Timepoint
The shoulder ROM in patients at the beginning of the study (before intervention) and at the end of physiotherapy sessions and one month after the last physiotherapy session
Method of measurement
Goniametr
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: The shoulder ROM of 33 patients with rotator cuff tear is first measured by goniometer and DASH questionnaire will be completed by them; then, they will be put under 12 sessions of physiotherapy as massaging, exercises and stretching of rotator cuff and Scapular muscles, Strength exercises and modalities including TENS, Laser and US as twice a week for 6 weeks, each session lasting 45 minutes, including 30 minutes of electrotherapy and 15 minutes of manual therapy. At the end of the physiotherapy sessions, the DASH questionnaire is completed again by the patient and the motor function is checked with a goniometer, and is compared with the pre-intervention; in fact, the control and intervention groups are in common.
Category
Lifestyle
2
Description
Intervention group2: The shoulder ROM of 33 patients with rotator cuff tear is first measured by goniometer and DASH questionnaire will be completed by them; then, they are injected by 80 mg of methylprednisolone and 1 ml of 2% Lidocaine by an orthopaedic physician in two phases within 21 days and 3 weeks after the second injection, DASH questionnaire is completed by the patient and the motor function is checked with a goniometer; and is compared with the pre-intervention; in fact, the control and intervention groups are in common.
Category
Lifestyle
3
Description
Intervention group3: The shoulder ROM of 33 patients with rotator cuff tear is first measured by goniometer and DASH questionnaire will be completed by them; they are injected by 80 mg of methylprednisolone and 1 ml of 2% Lidocaine and after 2 days, they will be put under 6 sessions of physiotherapy, twice a week for 3 weeks, each session lasts 45 minutes including 30 minutes of electrotherapy and 15 minutes of manual therapy by rehabilitation specialist and the second injection will be done again after 6 sessions of physiotherapy at the end of third week, and 6 sessions of physiotherapy will be done twice a week for 3 weeks, each session lasts 45 minutes (the physiotherapy steps are similar to the first group). At the end of the sessions, the DASH questionnaire is completed by the patient and the motor function is checked with a goniometer and is compared with the pre-intervention; in fact, the control and intervention groups are in common. At the end of the study, the data results before and after the intervention of these 3 groups will be compared.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Specialized clinics
Full name of responsible person
Shaahin hajivandi
Street address
No.38, payervan Ave., Andimeshk Town
City
Andimeshk
Province
Khouzestan
Postal code
6484113532
Phone
+98 61 4264 0419
Email
atousadachek@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dezfoul University of Medical Sciences
Full name of responsible person
Meysam mardsoltani
Street address
No.37, payervan Ave., Andimeshk Town
City
Andimeshk
Province
Khouzestan
Postal code
6484113532
Phone
+98 61 4264 0419
Email
atousadachek@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dezfoul 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
Dezfoul University of Medical Sciences
Full name of responsible person
Shaahin Hajivandi
Position
Academic staff of Dezful university of Medical sciences
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
No.38, payervan Ave., Andimeshk Town
City
Andimeshk
Province
Khouzestan
Postal code
6484113532
Phone
+98 61 4264 0419
Email
atousadachek@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dezfoul University of Medical Sciences
Full name of responsible person
Shaahin Hajivandi
Position
Academic staff of Dezful university of Medical sciences
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
No.38, payervan Ave., Andimeshk Town
City
Andimeshk
Province
Khouzestan
Postal code
6484113532
Phone
+98 61 4264 0419
Email
atousadachek@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Dezfoul University of Medical Sciences
Full name of responsible person
Shaahin Hajivandi
Position
Academic staff of Dezful university of Medical sciences
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
No.38, payervan Ave., Andimeshk Town
City
Andimeshk
Province
Khouzestan
Postal code
6484113532
Phone
+98 61 4264 0419
Email
atousadachek@gmail.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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Examining the separate and combined effects of physiotherapy treatment and corticosteroid injection on range of motion and pain in patients with complete rotator cuff tear referring to the specialized clinic in Dezfull city.
When the data will become available and for how long
2021/3/21 to 2021/9/21
To whom data/document is available
Enthusisasts the subject under study
Under which criteria data/document could be used
In case of obtain written consent
From where data/document is obtainable
project managers
What processes are involved for a request to access data/document