Protocol summary
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Study aim
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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
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Design
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Clinical trial with control group, double-blind, randomized by block design, on 34 patients
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Settings and conduct
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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
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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Muscle activity around the knee joint during walking and sit to stand task; Pain; Range of motion; Function; Strength
General information
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Reason for update
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Adding review of another functional activity
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20201128049511N3
Registration date:
2022-01-14, 1400/10/24
Registration timing:
registered_while_recruiting
Last update:
2023-01-06, 1401/10/16
Update count:
1
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Registration date
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2022-01-14, 1400/10/24
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-01-14, 1400/10/24
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Expected recruitment end date
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2022-08-20, 1401/05/29
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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Effect of Instrument Assisted Soft Tissue Mobilization on the Muscles around the Knee in People with Knee Osteoarthritis
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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
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Age
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From 45 years old to 80 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Outcome assessor
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Sample size
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Target sample size:
34
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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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.
Ethics committees
1
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Ethics committee
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Approval date
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2021-10-27, 1400/08/05
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Ethics committee reference number
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IR.MODARES.REC.1400.201
Health conditions studied
1
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Description of health condition studied
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Knee Osteoarthritis
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ICD-10 code
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M17
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ICD-10 code description
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Osteoarthritis of knee
Primary outcomes
1
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Description
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Muscles activity around the knee joint during walking and sit to stand task
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Timepoint
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Before and after the Intervention
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Method of measurement
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Surface electromyography device
2
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Description
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Pain
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Timepoint
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Before and after the Intervention
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Method of measurement
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Pain Visual Analogue Scale
3
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Description
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Strength
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Timepoint
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Before and after the Intervention
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Method of measurement
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Dynamometer
4
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Description
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Musculoskelatal performance
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Timepoint
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Before and after the Intervention
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Method of measurement
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Functional tests
5
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Description
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Range of motion
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Timepoint
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Before and after the Intervention
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Method of measurement
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Goniameter
Secondary outcomes
1
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Description
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Quality of life
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Timepoint
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Before and after the Intervention
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Method of measurement
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36 item short form quality of life questionnaire and lequesne algofunctional index Questionnaire
Intervention groups
1
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Description
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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.
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Category
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Treatment - Other
2
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Description
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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.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tarbiat Modares University
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Information about the main outcome can be shared after people are not identified
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When the data will become available and for how long
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After the results are published, the access phase started six months later
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To whom data/document is available
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Researchers in academic and research organizations will also have access to the data
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Under which criteria data/document could be used
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to do scientific research
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From where data/document is obtainable
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Sahar Boozari, Jalal Al Ahmad Highway, Tarbiat Modares University
s.boozari@modares.ac.ir, 00982182885053
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What processes are involved for a request to access data/document
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Send the project plan, and if approved, it will be sent following a complete evaluation of the persons and organizations involved in the project
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Comments
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