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: Effects of Blood Flow Restriction Exercises on Strength and Thickness of Supraspinatus Muscle and Level of Shoulder Pain at the Patients with Sub Acute Tendinopathy

Protocol summary

Study aim
to determine amount of effectiveness of Low load exercise with Blood Flow Restriction exercises on strength of stabilizer muscle of scapula and thickness and strength of supraspinatus muscle
Design
A concealed ,randomized, blinded , sham controlled clinical trial with parallel group design of 30 patient . The randomization sequence carried out with envelop
Settings and conduct
Subject: The effect of exercise therapy with Blood Flow Restriction on supraspinatus tendinopathy Location: Rehabilitation School Laboratory How to do the study: 1 - Check the entry conditions 2 - Patients enter the control and intervention group based on the envelope method 3- Determining the following items in the first session 1- Strength of middle and lower trapezius muscles and serratus anterior and supraspinatus using fixed dynamometer 2- Supraspinatus muscle thickness using ultrasound device 3- The threshold of compressive pain in the middle of the supraspinatus and deltoid bulk 4- The amount of 1RM using Brzycki formula and calculating 15 to 40% of it 5- Cuff pressure based on 50-80% of Limb Occlusion Pressure Exercise therapy protocol: 4 weeks (three days a week) Blinding method: Researcher blinding: Using another therapist Patient blinding: Using the same cuff with minimal pressure After 4 weeks, the evaluations of the first session are repeated. Determining the amount of pain in each session based on Pain Numeric scale
Participants/Inclusion and exclusion criteria
Inclusion criteria are patient with history of shoulder pain with age limit 30-65 & exclusion criteria are all factors that Blood Flow Restriction is contraindicated for them
Intervention groups
The intervention in intervention group is low load exercises with Blood Flow Restriction and the intervention in control group is low load exercises
Main outcome variables
changes in muscle strength and thickness , pain

General information

Reason for update
Acronym
BFR
IRCT registration information
IRCT registration number: IRCT20210210050317N1
Registration date: 2021-04-01, 1400/01/12
Registration timing: registered_while_recruiting

Last update: 2021-04-01, 1400/01/12
Update count: 0
Registration date
2021-04-01, 1400/01/12
Registrant information
Name
Zahra Poursaleh Begi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2244 6831
Email address
poursalehzahra@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-27, 1399/11/08
Expected recruitment end date
2022-03-16, 1400/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
: Effects of Blood Flow Restriction Exercises on Strength and Thickness of Supraspinatus Muscle and Level of Shoulder Pain at the Patients with Sub Acute Tendinopathy
Public title
the effect of Blood Flow Restriction Exercises on tendinopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
male and female with age limit 30-65 years old that have shoulder pain at least 1,5 month ago and at most 3 month ago the patient should have at least Positive 2 tests of these test: Painful Arch, Full Can, Empty Can and Hawkins patient that refer from orthopedic Doctors with sign and symptom of supraspinatus thendinopathy or if the patient have any evidence for tendinopathy with ultrasound and MRI
Exclusion criteria:
All contraindications of BFR( Blood Flow Restriction) , including history of blood clots, hypertension above 100/180, acute infection, peripheral vascular problems and varicose veins, cancer, Hemorrhagic or Thrombotic stroke, history of DVT( Deep Veins Thrombosis), Arterial fibrillation. Body Mass Index over 30 People taking medication for high blood pressure and blood sugar. People with a history of surgery, fractures or osteoarthritis in the shoulder area People who are suspected of having symptoms of COVID 19, such as fever, cough, runny nose, etc.
Age
From 30 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data and Safety Monitoring Board
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done using the envelope method in such a way that 30 envelopes are prepared and 15 numbers 1 (control group) and 15 numbers 2 (intervention group) are written on paper and placed inside the envelopes, after the sequence of envelopes is mixed, to select an envelope, all the envelopes are placed on the table to select them. After selecting the patient, the desired envelope is separated from the envelopes. This method is repeated for all patients. For the last patient, due to the fact that one envelope remains and according to the effect of the choice of others on the number of this envelope, a random state is maintained.
Blinding (investigator's opinion)
Double blinded
Blinding description
for blinding the researcher we will use another therapist for treatment in control and intervention group . patient blinding also will be doing with BFR cuff with minimal pressure
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
No. 8, Block 14, Entrance One, Nasr Alley, Nasr St , Shahid Mahallati Town , Aghdasiyeh Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1955743494
Approval date
2021-01-23, 1399/11/04
Ethics committee reference number
IR.TUMS.FNM.REC.1399.185

Health conditions studied

1

Description of health condition studied
Sub-acute Supraspinatus Tendinopathy
ICD-10 code
M75.80
ICD-10 code description
Other shoulder lesions, unspecified shoulder

Primary outcomes

1

Description
Supraspinatus strength
Timepoint
measurement of supraspinatus strength will do in first session and after 12 session ( 4 month later ,tree time a week)
Method of measurement
the approach of measurement the strength is using fixed Dynamometer

2

Description
Serratus - Anterior Strength
Timepoint
measurement of serratus anterior strength will do in first session and after 12 session ( 4 month later ,tree time a week)
Method of measurement
the approach of measurement the strength is using fixed Dynamometer

3

Description
middle and lower trapezius strength
Timepoint
measurement of Strength of Middle and Lower Trapezius Muscle will do in first session and after 12 session ( 4 month later ,tree time a week)
Method of measurement
the approach of measurement the strength is using fixed Dynamometer

4

Description
Supraspinatus Strength
Timepoint
measurment of supraspinatus thickness will do in first session and after 12 session ( 4 month later ,tree time a week)
Method of measurement
the approach of measurement the thickness is using Ultrasound devise

5

Description
Pain Pressure Threshould
Timepoint
measurement of pain pressure threshold will do in first session and after 12 session ( 4 month later ,tree time a week)
Method of measurement
the approach of measurement the Pain Pressure Threshold is using Algometer

6

Description
Pain Report in every session based on Pain Numeric Scale Approach
Timepoint
measurement the amount of pain will do at before and after of every session
Method of measurement
the approach of measurement the Pain is using Pain Numeric Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Using low load exercises with blood flow restriction device using strength training protocol in such a way that in the upper limb 50% of the pressure that causes the pulse to be cut is used and in the lower limb 80% of this pressure is used. The sports version is in 4 sets with 30 repetitions in the first set and 15 times in the other three sets. Exercises with low load (15-40% of the maximum weight that a person can lift once). The device used is the standard model of the blood flow restriction device, which has vascular Doppler, which has the Smart Tools brand from the United States.
Category
Rehabilitation

2

Description
Control group: Exercises with low load using the cuff of the same device with minimal pressure to prevent the effects of placebo. The number of repetitions and sets as well as the amount of exercise load is similar to the intervention group.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran University of Medical Science ,School of rehabilitation
Full name of responsible person
Zahra Poursaleh Begi
Street address
No. 8, Block 14, Entrance One, Nasr Alley, Nasr St , Shahid Mahallati Town , Aghdasiyeh Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1955743494
Phone
+98 21 2244 6831
Email
poursalehzahra@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Sahrayyian
Street address
No. 8, Block 1, Entrance One, Nasr Alley, Nasr St , Shahid Mahallati Town , Aghdasiyeh Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1955743494
Phone
+98 21 2244 6831
Email
poursalehzahra@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Zahra Poursaleh Begi
Position
Physiotherapist
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No. 8, Block 14, Entrance One, Nasr Alley, Nasr St , Shahid Mahallati Town , Aghdasiyeh Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1955743494
Phone
+98 21 2244 6831
Fax
Email
poursalehzahra@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Poursaleh Begi
Position
Master of science Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No. 8, Block 1, Entrance One, Nasr Alley, Nasr St , Shahid Mahallati Town , Aghdasiyeh Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1955743494
Phone
+98 21 2244 6831
Email
poursalehzahra@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Pourasaleh Begi
Position
Master of science student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No. 8, Block 14, Entrance One, Nasr Alley, Nasr St , Shahid Mahallati Town , Aghdasiyeh Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1955743494
Phone
+98 21 2244 6831
Email
poursalehzahra@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no additional information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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