The effect of lower extremity Myofascial Release on knee stiffness,swelling and pain after Total Knee Arthroplasty
Design
Therapeutic groups consisting of two groups of ten people are selected based on simple randomization.
Settings and conduct
Treatment of patients in the physiotherapy Clinic of Rehabilitation of Tehran University for two groups of ten patients with total knee arthroplasty who receive a group of routine physiotherapy and another group, in addition to routine physiotherapy, receives myofascial release.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients over 60 years of age who have had total knee arthroplasty surgery.Patients have had contracure of flexion of 10 degrees.
Exclusion criteria: Surgery other than Total Knee Arthroplasty, Revision TKA, Pain syndrome and acute infection, Rheumatoid arthritis, Motor neuron disease, Withdrawal from cooperation by the patient, Feeling uncomfortable and intolerant of pain by the patient, BMI over 40.
Intervention groups
Myofascial release is a manual technique performed as an intervention for a group of patients with knee arthroplasty. The other group receives only routine physiotherapy.
Main outcome variables
Active and passive range of motion by goniammeter, Pain by VAS scale,
Swelling by meter, Quadriceps strength, SF-36, WOMAC.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210115050038N1
Registration date:2021-03-21, 1400/01/01
Registration timing:registered_while_recruiting
Last update:2021-03-21, 1400/01/01
Update count:0
Registration date
2021-03-21, 1400/01/01
Registrant information
Name
Narjes Zoubin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3334 6777
Email address
nzoubin@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-21, 1400/01/01
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of lower extremity Myofascial Release on knee stiffness,swelling and pain after Total Knee Arthroplasty
Public title
Myofascial release in total knee arthroplasty
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
The patients over 60 years that have done surgery of total knee arthroplasty.
Patients have at least a contracture of flexion of ten degrees.
Exclusion criteria:
Surgeries other than total knee arthroplasty
Revision TKA
Pain syndrome and acute infection
Deep venous thrombosis
Fracture and scar
Rheumatoid arthritis
Motor neuron disease
Withdrawal from cooperation by the patient
Feeling uncomfortable and intolerant of pain by the patient
BMI>40 kg/m2
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who meet the inclusion criteria are randomly divided into two groups A and B ten. Random sequence through www.randomization.com so that each person with their eyes closed from inside a basket with numbers 1 to 20,pick a number to be in the group assigned to them by the site.Thus, patients are randomly divided into two groups of 10.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran Medical University
Street address
School Of Rehabilitation Tehran Medical University, Piche-Shemiran, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
11489-65111
Approval date
2021-02-05, 1399/11/17
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.1055
Health conditions studied
1
Description of health condition studied
Total Knee Arthroplasty
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Active & Passive Range of motion, VAS, Quadriceps Strength, SF-36, WOMAC.
Timepoint
First&tenth session
Method of measurement
Goniammeter, meter, SF-36 & WOMAC form.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group is a group that receives routine physiotherapy treatment and myofascial release as an intervener. Intervention is a type of manual massage performed by a physiotherapist and lasts about 5 minutes and does not require special equipment. The duration of treatment is ten sessions.The time of the physiotherapy session is about one hour. The evaluation of primary measures are done in the first session and tenth session.
Category
Treatment - Surgery
2
Description
Control group: The control group is the group that receives only routine physiotherapy.The duration of treatment is ten sessions.The time of the physiotherapy session is about one hour. The evaluation of primary measures are done in the first session and tenth session.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Rehabilitation Of School Of Tehran Medical University
Full name of responsible person
Zoubin Narjes
Street address
Rehabilitation of Tehran University, Piche-Shemiran, Tehran.
City
Tehran
Province
Tehran
Postal code
11489-65111
Phone
+98 21 7753 3939
Email
shadmehr@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran Medical University
Full name of responsible person
Zoubin Narjes
Street address
Rehabilitation Of School Of Tehran University, Piche-Shemiran, Tehran.
City
Tehran
Province
Tehran
Postal code
11489-65111
Phone
+98 21 7753 3939
Fax
+98 21 7753 4133
Email
shadmehr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran Medical University
Proportion provided by this source
50
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
Shadmehr Azadeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Of School Of Tehran University, Piche-Shemiran.
City
Tehran
Province
Tehran
Postal code
11489-65111
Phone
+98 21 7753 3939
Fax
+98 21 7753 4133
Email
shadmehr@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shadmehr Azadeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Of School Of Tehran Of University, Piche-Shemiran, Tehran.
City
Tehran
Province
Tehran
Postal code
11489-65111
Phone
+98 21 7753 3939
Fax
+98 21 7753 4133
Email
shadmehr@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zoubin,Narjes
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Of School Of Tehran University, Piche-Shemiran, Tehran.
City
Tehran
Province
Tehran
Postal code
11489-65111
Phone
+98 21 7753 3939
Email
nzoubin@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
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
The first outcome measures have to been assessed.
When the data will become available and for how long
From farvardin 1400 untile doing treatment of 20 cases.
To whom data/document is available
Consulting and Supervisor teachers
Under which criteria data/document could be used
Just for searching
From where data/document is obtainable
Rehabilitation Of School Of Tehran University, Piche-Shemiran, Tehran.
dr. shadmehr
What processes are involved for a request to access data/document
Ten session of patient treatment are performed according to the surgeon`s instructions, routine physiotherapy.