Comparing the Effectiveness of Six Weeks of Water Based Neuromuscular and transcranial direct current stimulation Exercises on Pain, Function, Knee Instability, and Quality of Life of Women with Knee Osteoarthritis and Knee Instability Characteristics.
Comparison of the effectiveness of six weeks of neuromuscular exercises in water and transcranial direct current stimulation on pain, function, joint instability, and quality of life in women with knee osteoarthritis with voiding characteristics.
Design
The clinical trial - double-blind - phase 3 - controlled - randomized with parallel groups and pre-test-post-test design will be conducted on 35 patients, and random allocation software will be used for randomization.
Settings and conduct
This study will be executed at the Razi University of Kermanshah. Subjects will be randomly assigned to two groups of water-based neuromuscular exercises + anodal-tDCS (n=16) and water-based neuromuscular exercises + sham-controlled tDCS (n=16). Randomization and allocation of the subjects is done with Random allocation software and the SNOSE method. After the evaluation, one of the envelopes is opened by the evaluator and both the subject and the evaluator are informed of the assigned group. considering that the subjects of both groups receive the same method of treatment, subjects will also be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria
American College of Rheumatology with at least 3 of the following 6 features:
- Self-reported knee instability
- Minimum pain intensity of 4 on a visual scale.
- Kellgren and Lawrence ≤ II
Exclusion criteria
- BMI>40 kg/m2
- brain tumor, seizure, or intracranial metal implantation.
- Unable to walk without assistive devices.
- People with neuromuscular diseases
- Treated with other interventions in the last three months.
- Simultaneous hip osteoarthritis, knee joint surgery, or arthroplasty.
Intervention groups
neuromuscular exercises in combination with tDCS stimulation of the M1 point
Main outcome variables
pain and function
General information
Reason for update
Acronym
آرتروز زانو
IRCT registration information
IRCT registration number:IRCT20231106059975N1
Registration date:2024-07-08, 1403/04/18
Registration timing:retrospective
Last update:2024-07-08, 1403/04/18
Update count:1
Registration date
2024-07-08, 1403/04/18
Registrant information
Name
Asma Tapeh kaboodi
Name of organization / entity
Razi University of Kermanshah
Country
Iran (Islamic Republic of)
Phone
+98 83 3432 4979
Email address
kaboodiasma@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-05, 1403/01/17
Expected recruitment end date
2024-06-06, 1403/03/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effectiveness of Six Weeks of Water Based Neuromuscular and transcranial direct current stimulation Exercises on Pain, Function, Knee Instability, and Quality of Life of Women with Knee Osteoarthritis and Knee Instability Characteristics.
Public title
The effect of hydrotherapy and Tdcs stimulation on knee arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
- Age more than 40 years-
- Having the clinical criteria of the American College of Rheumatology for knee OA (Altman et al., 1986)
reported knee instability-
Self-Estimating the scale of radiographic disease severity of Kellgren and Lawrence ≤ II
Exclusion criteria:
- Body mass index greater than or equal to BMI>40 kg/m2Uncontrolled blood pressure.
A history of stroke, brain surgery, brain tumor, seizure, or intracranial metal implantation. - Patients who are unable to walk without assistive devices. Have.-
Patients who have been treated with other interventions in the last three months.- History of fracture and surgery in the lower limb.-
Concomitant hip osteoarthritis, knee joint surgery or arthroplasty. - Hospitalized for mental illness in the past year.
Uncontrolled blood pressure.
Age
From 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
35
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, randomization of the subjects is done with Random allocation software version 1.0.0 by a person not involved in the research, and the assigned group is placed in a matte envelope (SNOSE method).
Blinding (investigator's opinion)
Double blinded
Blinding description
After the evaluation of each participant by Eziab, one of these envelopes is opened by the evaluator and both the subject and the evaluator are informed of the assigned group. In this way, the evaluator will not be informed about the allocation process and the assigned group of the subject. In addition, considering that the subjects of both groups receive the same method of treatment (both groups of neural exercises - have muscular stimulation with the difference in the type of stimulation that the intervention group is real stimulation and the control group is fake stimulation) those subjects will also be blinded from the research process.
Placebo
Used
Assignment
Parallel
Other design features
No explanation needed
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Razi University
Street address
Kermanshah- 4040 Artesh district- Tawheed Street- 7 Nasim Alley- 5 South House
City
Kermansha
Province
Kermanshah
Postal code
6717737435
Approval date
1997-12-27, 1376/10/06
Ethics committee reference number
IR.RAZI.REC.1402.038
Health conditions studied
1
Description of health condition studied
knee osteoarthritis
ICD-10 code
M15-M19 Ar
ICD-10 code description
Chapter XIIIDiseases of the musculoskeletal system and connective tissue(M00-M99)
Primary outcomes
1
Description
- Visual analog scale
Timepoint
Before starting training interventions and re-measurement after 6 weeks
Method of measurement
VAS visual pain intensity is used to measure the intensity of perceived pain. In this way, a 10 cm long horizontal ruler is placed in front of the patient, with zero at the beginning and 10 at the end, 0 (no pain) to 10 (the most severe pain). The obtained number will be recorded as the severity of the patient's knee pain.-
2
Description
Function
Timepoint
Before starting training interventions and re-measurement after 6 weeks
Method of measurement
Performance is one of the indicators of functional evaluation in patients with knee osteoarthritis using the WOMAC questionnaire, which contains five options, where the severe symptoms are graded from (0 none to 4 very severe) and the patient chooses one of them. "Womac" strength has three subscales of pain with a score of (0-20), stiffness with a score of joint stiffness (0-8), and physical performance with a score of (0-68). A higher score indicates more severe symptoms.
3
Description
Knee instability
Timepoint
Before starting training interventions and re-measurement after 6 weeks
Method of measurement
Knee instability will be reported by the person himself using the Felson questionnaire. In response to the question, does the knee's degree of deviation, bending, or displacement affect your daily activities? "Rated as 5=I have no symptoms, 4=I have no symptoms but it does not affect my daily activities, 3=Symptoms slightly affect my daily activities, 2=Symptoms moderately affect my daily activities, 1=severe symptoms affect my daily ADL activities, 0=symptoms prevent me from doing all of my daily activities
4
Description
Muscles strength
Timepoint
Before starting training interventions and re-measurement after 6 weeks
Method of measurement
The strength of the knee (hip abductors and extensors; knee flexors and extensors groups muscles) will be evaluated using a manual Pull-Push dynamometer made in the United States
5
Description
knee proprioception
Timepoint
Before starting training interventions and re-measurement after 6 weeks
Method of measurement
To evaluate the sense of depth of the knee, the target angle (45, 70 degrees) reconstruction method is used. .
Secondary outcomes
1
Description
- Plantar pressure distribution system (foot pressure measurement system) -
Timepoint
Before starting training interventions and re-measurement after 6 weeks
Method of measurement
will check the condition of subjects with a PT-Scan device (made in Iran). 1. Static: the subjects will be placed on the foot pressure machine with bare feet for 20 seconds without any movement. 2. Dynamics: the subjects will be asked to start walking normally in the path of the pressure distribution device, while moving, a middle step will be selected from the device, and its data will be recorded. 3. Fluctuations of the center of pressure: (COP) To perform this test, the subjects will be placed on the foot pressure machine without using shoes for 20 seconds without moving.
2
Description
Kinesiophobia
Timepoint
Before starting training interventions and re-measurement after 6 weeks
Method of measurement
TSK is a 17-item scale where each item is answered on a four-point Likert scale. Scores are given in a range of 4 (1 means completely disagree 4 means completely agree). The final score is 68-17. Scores above 37 indicate a high degree of phobia. Its 2, 1, and 4 factorial structural models have been implemented. Among them, the two-factor model is preferable and is used more due to its adaptation to the patient's conditions and different situations.
3
Description
Gait kinematics and acceleration-movement
Timepoint
Before starting training interventions and re-measurement after 6 weeks
Method of measurement
Gait kinematics and acceleration-movement of the lower leg kinematic analysis of gait based on two-dimensional video D-GKA2 is a simple, practical, and inexpensive method in which two video cameras and passive markers are used. The patient is asked to walk on a treadmill at a speed of 1.5 m/s and video records are collected for 60 seconds; The recorded video records were analyzed using Kinovea software version 8.15, which is a free two-dimensional motion analysis software used to evaluate the kinematic parameters of walking. During the phases (midstance, pre-swing, midswing, late swing) that require a maximum range of motion in the knee and ankle joints, kinematic analyses will be performed in the sagittal plane and only in the knee and ankle joints. The filming process will last for six minutes; The first two minutes will not be recorded to familiarize yourself with the conditions of walking on the treadmill, and the last two minutes will not be recorded to avoid disturbing the usual walking condition, and only the middle two minutes will be used for evaluations.
4
Description
Before starting training interventions and re-measurement after 6 weeks
Timepoint
Before starting training interventions and re-measurement after 6 weeks
Method of measurement
The SF-36 quality of life questionnaire is a comprehensive questionnaire to measure the quality of life in all health-related issues. The validity and reliability of the SF-36 questionnaire were evaluated for the first time in Iran by Montazeri et al.
Intervention groups
1
Description
Intervention group: In this study, the participants were randomly selected based on the inclusion criteria with a ratio of 1 to 1 in the groups of neuromuscular exercises in water (n=20) and neuromuscular exercises in water in combination with intervention. tDCS will be performed in the water environment (n=20).
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi University of Kermanshah-Laboratory of Faculty of Sports Sciences
Full name of responsible person
Farzaneh gandomi Asma tapehkaboodi
Street address
Kermanshah, Taq Bostan, University Street, Razi University. Faculty of Sports Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 905 952 5374
Fax
+98 83 3427 4555
Email
info@razi.ac.ir
Web page address
https://razi.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Razi University
Full name of responsible person
Farzaneh Gandomi
Street address
Kermanshah- Bagh-e-Abrisham- Razi University- Faculty of Sports Sciences