Protocol summary
-
Study aim
-
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 a pre-test-post-test design.
-
Settings and conduct
-
The location of the project is Razi University. Subjects will be randomly assigned to two experimental and control groups (20). Randomization and assignment of subjects will be done with Random allocation software and SNOSE method. In addition to the assessor, given that subjects in both groups will receive the same treatment process, those subjects will also be blinded to the research process.
-
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, intracranial metal implantation; Unable to walk without assistive devices; People with neuromuscular diseases;Treated with other interventions in the last three months.
-
Intervention groups
-
Experimental group: Neuromuscular training (NMT) + tDCS (M1): NMT was performed for 6 weeks, three sessions per week, each session lasting one hour, and tDCS intervention was performed immediately before aqua-NMT for 20 minutes.
Control group: NNMT+placebo tDCS: The entire intervention was similar to the experimental group, except that instead of active stimulation, the stimulation was inactive.
-
Main outcome variables
-
Pain and function
General information
-
Reason for update
-
Due to the completion of patient recruitment, I inform you of the executed dates of recruitments.
-
Acronym
-
آرتروز زانو
-
IRCT registration information
-
IRCT registration number:
IRCT20231106059975N1
Registration date:
2024-07-08, 1403/04/18
Registration timing:
prospective
Last update:
2025-02-06, 1403/11/18
Update count:
1
-
Registration date
-
2024-07-08, 1403/04/18
-
Registrant information
-
-
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
-
2024-08-22, 1403/06/01
-
Actual recruitment end date
-
2024-12-10, 1403/09/20
-
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/m2
Had a history of stroke, brain surgery, brain tumor, seizure, or intracranial metal implantation.
Patients who are unable to walk without an assistive device.
People who have neuromuscular disease (multiple sclerosis, Parkinson's, etc.).
Patients who have undergone other interventions in the past three months.
History of fractures and surgery in the lower extremities.
Concomitant hip osteoarthritis, knee joint surgery, or being scheduled for arthroplasty.
Hospitalization in the past year for mental illness.
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
Actual sample size reached:
40
-
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
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2023-06-21, 1402/03/31
-
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
-
Pain intensity
-
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 situation
-
Timepoint
-
Before starting training interventions and re-measurement after 6 weeks
-
Method of measurement
-
The condition of balance of subjects will be checked with a PT-Scan device (made in Iran).
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
1
-
Sponsor
-
-
Grant name
-
Iran National Science Foundation
-
Grant code / Reference number
-
4021257
-
Is the source of funding the same sponsor organization/entity?
-
No
-
Title of funding source
-
Iran National Science Foundation
-
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
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
-
Not applicable
-
Title and more details about the data/document
-
All data extracted from the research plan can be made available to the corresponding author upon reasonable request
-
When the data will become available and for how long
-
Every time
-
To whom data/document is available
-
Authors of articles - researchers and researchers
-
Under which criteria data/document could be used
-
For use in meta-analyses and extensive global studies on the investigated problem
-
From where data/document is obtainable
-
Corresponding author, dr Farzaneh Gandomi, and requesting email to gandomi777@gmail.com
-
What processes are involved for a request to access data/document
-
The received request will be checked by the research team and if the request is reasonable, it will be made available through the corresponding author up to one week.
-
Comments
-