The Effect of Neruomuscular Exercises in Combination with Cognitive-Motivational and Mindfulness Interventions on Pain, Function, Neurofeedback Factores, Kinesiophobia, and Self-Reported Knee Instability Improvement in Patients with Knee Osteoarthritis
the effect of neuromuscular Exercises with combining cognitive-motivational and mindfulness interventions on pain relief, function, Knee contracture, knee confidence, Kinesiophobia and self-report instability in patients with osteoarthritis of the knee
Design
Double-blind clinical trial (patient and researcher) with parallel groups and control group, assignment in groups based on random number (G-Power statistical software), then each number will be written in an envelope and the envelope will be placed in the bag when the patient is admitted separately Present to each patient and each patient randomly removes a number from the bag and opens it and announces it to the researcher and the number of each person is recorded in the file by the researcher) The study will be performed with a pre-test-post-test plan .
Settings and conduct
Patients were admitted to Omid Clinic under the supervision of a specialist physician in Hamadan. Study of a double-blind clinical trial (researcher and patient). The experiments were performed in the correctional movements laboratory of Bu Ali Sina University.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age over 40 years with a score of at least 2 in the KL criterion, chronic knee pain, failure to use any type of psychological intervention
Exclusion criteria: Age under 40 years, uncontrolled diabetes (BMI> 40kg / m2), neuromuscular disorders (stroke, stiffness, tumor, MS and Parkinson's), fractures and surgery in the lower extremities
Intervention groups
Group one: Neuromuscular exercises with motivational cognitive interventions
Group 2 - Neuromuscular exercises with mindfulness and neurofeedback interventions
The Effect of Neruomuscular Exercises in Combination with Cognitive-Motivational and Mindfulness Interventions on Pain, Function, Neurofeedback Factores, Kinesiophobia, and Self-Reported Knee Instability Improvement in Patients with Knee Osteoarthritis
Public title
The Effect of Neruomuscular Exercises in Patients with Knee Osteoarthritis
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 40 years
Having clinical criteria for osteoarthritis of the knee of the College of Rheumatology
Have a score of at least 2 on the Kelgren and Lawrence criteria
Chronic knee pain for at least 3 months
Pain score 8-6 of the VAS scale
Without use any type of psychological intervention / other counseling during periods that subjects are studying.
Exclusion criteria:
Age under 40 years
Body mass index greater than or equal to (BMI> 40kg / m2),
Additional orthopedic injuries in the lower extremities
Neuromuscular disorders that interfere with daily functioning (such as stroke, uncontrolled muscle stiffness, MS and Parkinson's) that interfere with the exercise program
Fractures and surgery in the lower extremities
Taking psychiatric medication or seeing a behavioral specialist in the past six months that prevents you from exercising
Age
From 40 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects will be randomized based on Random Number Generator software and then assigned to three groups based on SNOSE allocation concealment. Participants will be randomly assigned to one of the groups of neuromuscular exercises with motivational cognitive interventions, neuromuscular exercises with mindfulness interventions and control group. So that 15 people were identified for group one, 15 people for group two and 15 people for control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the researcher will have no information about the exercises and interventions assigned to the groups, the subjects will be unaware of the existence of parallel groups, as well as the possibility of not informing the person who is analyzing the data. There will be groups and exercises assigned to them
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
IR.RAZI.REC
Street address
Ghods town (west), between South Flamek and Zarafshan, Iran TV St. - Headquarters of the Ministry of Health, Treatment and Medical Education, Block A, 13th floor
City
tehran
Province
Tehran
Postal code
۶۷۱۴۱۱۵۱۱۱
Approval date
2021-02-24, 1399/12/06
Ethics committee reference number
IR.RAZI.REC.1400.006
Health conditions studied
1
Description of health condition studied
Knee osteoarthritis
ICD-10 code
M17.2
ICD-10 code description
Bilateral post-traumatic osteoarthritis of knee
Primary outcomes
1
Description
Evaluation of pain on a visual scale of pain
Timepoint
Before the intervention, after 45, 60 days after the start of Neuromuscular Exercises
Method of measurement
visual scale of pain(VAS)
Secondary outcomes
1
Description
Function
Timepoint
Before the intervention, after 45, 60 days after the start of Neruomuscular Exercises
Method of measurement
Western Ontario and McMasters Universities Osteoarthritis Index(WOMAC)
2
Description
Quality of Life
Timepoint
Before the intervention, after 45, 60 days after the start of Neruomuscular Exercises
Method of measurement
The World Health Organization Quality of Life(SF36)
3
Description
Kinesiophobia
Timepoint
Before the intervention, after 45, 60 days after the start of Neruomuscular Exercises
Method of measurement
Tampa scale
4
Description
Knee contracture
Timepoint
Before the intervention, after 45, 60 days after the start of Neruomuscular Exercises
Method of measurement
Universal goniometer
5
Description
Balance
Timepoint
Before the intervention, after 45, 60 days after the start of Neruomuscular Exercises
Method of measurement
Berg balance scale-Biodex Stability System (BSS)
6
Description
Neurofeedback factors
Timepoint
Before the intervention, after 45, 60 days after the start of Neruomuscular Exercises
Method of measurement
With ProCamp Infini device and Infinity Biography software
7
Description
Sole pressure distribution
Timepoint
Before the intervention, after 45, 60 days after the start of Neruomuscular Exercises
Method of measurement
with foot pressure measurement system(FScan II)
8
Description
Knee instability
Timepoint
Before the intervention, after 45, 60 days after the start of Neruomuscular Exercises
Method of measurement
Felson Questionnaire
9
Description
knee proprioception
Timepoint
Before the intervention, after 45, 60 days after the start of Neruomuscular Exercises
Method of measurement
Universal goniometer
10
Description
knee flexion (ROM)
Timepoint
Before the intervention, after 45, 60 days after the start of Neruomuscular Exercises
Method of measurement
Universal goniometer
Intervention groups
1
Description
Intervention group: Neuromuscular Exercises with Motivational Cognitive Interventions
Category
Other
2
Description
Intervention group: Neuromuscular Exercises with Mindfulness and Neurofeedback Interventions
Category
Other
3
Description
Control group: Neuromuscular training group In this group, exercises will be performed three times a week for 6 weeks and 60 minutes in 2 to 3 sets with 10-15 repetitions and rest and three levels between exercises and sets. Difficulty was considered for each exercise. These exercises will be performed on both healthy and diseased feet, although the focus is on the injured foot.
Category
Other
4
Description
Intervention group 1: Neuromuscular exercises with cognitive-motivational interventions such as control group Neuromuscular exercises in addition to ten - 15 minutes of motivational interview exercises in the form of motivational speeches designed according to the table and showing motivational images and functional images to the elderly in person and online In 8 sessions along with 8 weeks of neuromuscular training
Category
Other
5
Description
Intervention group 2 :Performing neuromuscular exercises Like the control group, with mindfulness exercises based on stress reduction for ten to fifteen minutes per session along with 8 weeks of neuromuscular exercises
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid specialized and sub-specialized clinic
Full name of responsible person
Alireza Fazaeli
Street address
Omid Specialized Clinic- next to Payam Hall- Sabad Bafan Street- Palestine Square – Hamedan-Iran