Effect of Instrument-Assisted Soft Tissue Mobilization on Muscular Activity during Walking and Sit to Stand Task in Individuals with Knee Osteoarthritis
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Protocol summary
Muscle activity around the knee joint during walking and sit to stand task; Pain; Range of motion; Function; Strength
Muscle activity around the knee joint during walking and sit to stand task; Pain; Function; Strength
Muscle activity around the knee joint during walking and sit to stand task; Pain; Range of motion; Function; Strength
فعالیت عضلات اطراف مفصل زانو حین راه رفتن و فعالیت ایستادن از وضعیت نشسته؛ درد؛ دامنه حرکتی؛ عملکرد؛ قدرت
فعالیت عضلات اطراف مفصل زانو حین راه رفتن و فعالیت ایستادن از وضعیت نشسته؛ درد؛ عملکرد؛ قدرت
فعالیت عضلات اطراف مفصل زانو حین راه رفتن و فعالیت ایستادن از وضعیت نشسته؛ درد؛ دامنه حرکتی؛ عملکرد؛ قدرت
General information
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2022-05-17, 1401/02/27
2022-05-17 00:00:00
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2023-08-15, 1402/05/24
2023-08-15 00:00:00
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2023-08-15, 1402/05/24
2023-08-15 00:00:00
Adding review of another functional activity
Updating to provide accurate and up-to-date information about the study
Adding review of another functional activityUpdating to provide accurate and up-to-date information about the study
اضافه شدن بررسی یک فعالیت عملکردی دیگر
بهروزرسانی برای ارائه اطلاعات دقیق و بهروز درباره مطالعه
اضافه شدن بررسی یک فعالیت عملکردی دیگربهروزرسانی برای ارائه اطلاعات دقیق و بهروز درباره مطالعه
Primary outcomes
#1
Pain
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Pain
درد
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درد
Before and after the Intervention
empty
Before and after the Intervention
قبل و بعد از مداخله
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قبل و بعد از مداخله
Pain Visual Analogue Scale
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Pain Visual Analogue Scale
مقیاس بینایی آنالوگ درد
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مقیاس بینایی آنالوگ درد
#2
Strength
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Strength
قدرت
empty
قدرت
Before and after the Intervention
empty
Before and after the Intervention
قبل و بعد از مداخله
empty
قبل و بعد از مداخله
Dynamometer
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Dynamometer
نیرو سنج
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نیرو سنج
#3
Musculoskelatal performance
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Musculoskelatal performance
عملکرد سیستم عضلانی اسکلتی
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عملکرد سیستم عضلانی اسکلتی
Before and after the Intervention
empty
Before and after the Intervention
قبل و بعد از مداخله
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قبل و بعد از مداخله
Functional tests
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Functional tests
آزمون های عملکردی
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آزمون های عملکردی
#4
Range of motion
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Range of motion
دامنه حرکتی
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دامنه حرکتی
Before and after the Intervention
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Before and after the Intervention
قبل و بعد از مداخله
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قبل و بعد از مداخله
Goniameter
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Goniameter
گونیامتر
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گونیامتر
Secondary outcomes
#1
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Pain
Pain
empty
درد
درد
empty
Before and after the Intervention
Before and after the Intervention
empty
قبل و بعد از مداخله
قبل و بعد از مداخله
empty
Pain Visual Analogue Scale
Pain Visual Analogue Scale
empty
مقیاس بینایی آنالوگ درد
مقیاس بینایی آنالوگ درد
#2
empty
Strength
Strength
empty
قدرت
قدرت
empty
Before and after the Intervention
Before and after the Intervention
empty
قبل و بعد از مداخله
قبل و بعد از مداخله
empty
Dynamometer
Dynamometer
empty
نیروسنج
نیروسنج
Protocol summary
Study aim
Investigate the effect of Instrument Assisted Soft Tissue Mobilization on function, quality of life and activity of muscles around the knee joint at different preferential and high walking speeds and sit to stand task in people with knee osteoarthritis
Design
Clinical trial with control group, double-blind, randomized by block design, on 34 patients
Settings and conduct
The location of this intervention will be in the research therapeutic center of movement disorders, Department of physiotherapy, Tarbiat Modares University. After an introductory session, people will enter the intervention phase. Individuals will be randomly assigned to the treatment and placebo groups. Participants and outcome assessors are unaware of the allocation of study groups. The intervention will be performed in four sessions over two weeks
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women and men with knee osteoarthritis, a positive Clark test, and two and three degrees of osteoarthritis, according to the kellgren Lawrence scale؛ Exclusion criteria: Having a history of hip or knee joint fracture or ligament injury on the affected side that resulted in permanent injury
Intervention groups
In the intervention group, soft tissue mobilization will be performed with the instrument, but the control group will receive the instrument as a placebo. Both groups will do strengthening and stretching exercises. The intervention will be performed for both groups in four sessions over two weeks.
Main outcome variables
Muscle activity around the knee joint during walking and sit to stand task; Pain; Function; Strength
General information
Reason for update
Updating to provide accurate and up-to-date information about the study
Acronym
IRCT registration information
IRCT registration number:IRCT20201128049511N3
Registration date:2022-01-14, 1400/10/24
Registration timing:prospective
Last update:2025-07-27, 1404/05/05
Update count:2
Registration date
2022-01-14, 1400/10/24
Registrant information
Name
Sahar Boozari
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 5053
Email address
s.boozari@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-14, 1400/10/24
Expected recruitment end date
2022-08-20, 1401/05/29
Actual recruitment start date
2022-05-17, 1401/02/27
Actual recruitment end date
2023-08-15, 1402/05/24
Trial completion date
2023-08-15, 1402/05/24
Scientific title
Effect of Instrument-Assisted Soft Tissue Mobilization on Muscular Activity during Walking and Sit to Stand Task in Individuals with Knee Osteoarthritis
Public title
Effect of Instrument Assisted Soft Tissue Mobilization on the Muscles around the Knee in People with Knee Osteoarthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women and men with osteoarthritis of the knee
Ability to walk without the use of assistive devices
Pain between three and six in one knee, according to the visual analogue scale
A positive clark test result
Grade two and three osteoarthritis according to the Kellgren-Lawrence scale
Exclusion criteria:
Have a history of a hip or knee joint fracture or ligament injury on the affected side that has resulted in permanent injury
Candidate for knee replacement surgery
Any congenital disease of the lower extremities or lower back, or any orthopedic, neurological, or rheumatic disease that interferes with a person's normal gait or sit to stand task
The difference in the length of the lower limbs is more than one and a half centimeters
Body mass index above 30
Genovarum with a knee angle greater than 10 degrees
Joint injection in the last six months
Medium to high intensity involvement of both knees
Age
From 45 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
34
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals are admitted to the study depending on criteria for inclusion and exclusion. The stratified block randomization approach will be used for this study's randomization. People with moderate osteoarthritis are classified into two subgroups based on the amount of pain (three and four) or (five and six). In each subgroup, randomization is performed by four blocks (two in the treatment group and two in the placebo group). For random allocation, code 1 for treatment and code 0 for placebo are placed in sealed envelopes. In this way, the people of each subgroup take one of the sealed envelope and are assigned in the treatment or placebo group according to the code.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will be randomly divided into two groups of treatment and placebo. In the treatment group, the master therapist uses soft tools to treat soft tissue by selecting pressure, direction, type of stroke, distance, duration, speed and type of tool. But in the placebo group, the use of the tool is dramatic and has no therapeutic properties. Both groups receive the same strengthening and stretching exercises so people do not notice this difference. The evaluator is also blind.
Placebo
Used
Assignment
Parallel
Other design features
Individuals are randomly divided into two groups. Therapeutic exercise is common in both groups. The intervention group receives the instrument but the control group receives the instrument as a placebo.
Secondary Ids
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Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tarbiat Modares University
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al Ahmad Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713116
Approval date
2021-10-27, 1400/08/05
Ethics committee reference number
IR.MODARES.REC.1400.201
Health conditions studied
1
Description of health condition studied
Knee Osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Muscles activity around the knee joint during walking and sit to stand task
Timepoint
Before and after the Intervention
Method of measurement
Surface electromyography device
Secondary outcomes
1
Description
Quality of life
Timepoint
Before and after the Intervention
Method of measurement
36 item short form quality of life questionnaire and lequesne algofunctional index Questionnaire
2
Description
Pain
Timepoint
Before and after the Intervention
Method of measurement
Pain Visual Analogue Scale
3
Description
Strength
Timepoint
Before and after the Intervention
Method of measurement
Dynamometer
Intervention groups
1
Description
Intervention group: A series of lightweight steel instruments are gently applied to the muscles around the knee. The movement of the instrument in specific therapeutic directions is applied to the skin based on the initial assessment, and an emollient is used to move the instrument more easily. The treatment time with this tool is approximately five minutes. Then stretching and strengthening exercises are performed.
Category
Treatment - Other
2
Description
Control group: Steel instruments are gently applied to the muscles around the knee in this group. Using an emollient, the instrument is applied as a placebo with the least amount of pressure on the skin in all directions. The tool is moved on the patient's skin in different directions without considering the initial assessment. The direction and pressure applied by the instrument have no therapeutic properties. The treatment time is approximately five minutes. Then stretching and strengthening exercises are performed.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Research-therapeutic center of movement disordes, Tarbiat Modares University
Full name of responsible person
Sahar Boozari
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al Ahmad Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 5053
Fax
+98 21 8800 6544
Email
s.boozari@modares.ac.ir
Web page address
http://ptmodares.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Amir Abdollahzadeh
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al Ahmad Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 2009
Fax
+98 21 8288 3101
Email
Res@modares.ac.ir
Web page address
https://res.modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
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
Tarbiat Modares University
Full name of responsible person
Bahare Jafarsalehi
Position
Master of Science Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al Ahmad Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 5052
Fax
+98 21 8800 6544
Email
b.jafarsalehi@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Sahar Boozari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al Ahmad Highway, Tehran, Iran