Protocol summary
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Study aim
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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
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Design
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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 .
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Group one: Neuromuscular exercises with motivational cognitive interventions
Group 2 - Neuromuscular exercises with mindfulness and neurofeedback interventions
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Main outcome variables
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Pain, Physical function, Quality of life, knee proprioception, Knee contracture, Balance, knee flexion ROM, Kinesiophobia, Knee instability, Foot pressure, Neurofeedback variables
General information
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Reason for update
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Modify the sampling date
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210417050997N1
Registration date:
2021-07-05, 1400/04/14
Registration timing:
prospective
Last update:
2021-07-12, 1400/04/21
Update count:
1
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Registration date
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2021-07-05, 1400/04/14
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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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2021-08-01, 1400/05/10
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Expected recruitment end date
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2021-10-22, 1400/07/30
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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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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
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Public title
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The Effect of Neruomuscular Exercises in Patients with Knee Osteoarthritis
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Purpose
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Other
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Inclusion/Exclusion criteria
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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
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Age
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From 40 years old to 60 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
45
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-02-24, 1399/12/06
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Ethics committee reference number
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IR.RAZI.REC.1400.006
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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M17.2
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ICD-10 code description
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Bilateral post-traumatic osteoarthritis of knee
Primary outcomes
1
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Description
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Evaluation of pain on a visual scale of pain
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Timepoint
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Before the intervention, after 45, 60 days after the start of Neuromuscular Exercises
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Method of measurement
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visual scale of pain(VAS)
Secondary outcomes
1
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Description
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Function
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Timepoint
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Before the intervention, after 45, 60 days after the start of Neruomuscular Exercises
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Method of measurement
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Western Ontario and McMasters Universities Osteoarthritis Index(WOMAC)
2
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Description
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Quality of Life
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Timepoint
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Before the intervention, after 45, 60 days after the start of Neruomuscular Exercises
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Method of measurement
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The World Health Organization Quality of Life(SF36)
3
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Description
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Kinesiophobia
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Timepoint
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Before the intervention, after 45, 60 days after the start of Neruomuscular Exercises
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Method of measurement
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Tampa scale
4
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Description
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Knee contracture
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Timepoint
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Before the intervention, after 45, 60 days after the start of Neruomuscular Exercises
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Method of measurement
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Universal goniometer
5
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Description
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Balance
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Timepoint
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Before the intervention, after 45, 60 days after the start of Neruomuscular Exercises
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Method of measurement
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Berg balance scale-Biodex Stability System (BSS)
6
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Description
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Neurofeedback factors
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Timepoint
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Before the intervention, after 45, 60 days after the start of Neruomuscular Exercises
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Method of measurement
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With ProCamp Infini device and Infinity Biography software
7
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Description
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Sole pressure distribution
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Timepoint
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Before the intervention, after 45, 60 days after the start of Neruomuscular Exercises
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Method of measurement
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with foot pressure measurement system(FScan II)
8
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Description
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Knee instability
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Timepoint
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Before the intervention, after 45, 60 days after the start of Neruomuscular Exercises
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Method of measurement
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Felson Questionnaire
9
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Description
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knee proprioception
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Timepoint
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Before the intervention, after 45, 60 days after the start of Neruomuscular Exercises
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Method of measurement
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Universal goniometer
10
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Description
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knee flexion (ROM)
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Timepoint
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Before the intervention, after 45, 60 days after the start of Neruomuscular Exercises
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Method of measurement
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Universal goniometer
Intervention groups
1
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Description
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Intervention group: Neuromuscular Exercises with Motivational Cognitive Interventions
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Category
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Other
2
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Description
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Intervention group: Neuromuscular Exercises with Mindfulness and Neurofeedback Interventions
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Category
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Other
3
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Description
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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.
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Category
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Other
4
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Description
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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
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Category
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Other
5
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Description
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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
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Category
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Other
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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Razi University
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Proportion provided by this source
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25
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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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available