Back to resultsCentral Sensitization in Knee Osteoarthritis
Primary Purpose
Osteo Arthritis Knee, Central Sensitisation
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
balance exercises
Sponsored by
About this trial
This is an interventional treatment trial for Osteo Arthritis Knee focused on measuring central sensitisation, osteoarthritis, balance exercises
Eligibility Criteria
Inclusion Criteria:
- Being diagnosed with primary knee osteoarthritis according to American College of Rheumatology criteria,
- To be stage 2-3-4 knee osteoarthritis according to Kellgren Lawrence radiological staging,
- To be with a central sensitization score of over 40 according to the CSI,
- To be able to fill the scales and accept to participate in the study.
Exclusion Criteria:
- Being diagnosed with secondary osteoarthritis or inflammatory rheumatic disease,
- Having cognitive impairment,
- To have been treated with physiotherapy, with an intra articular injection or with a surgery from the knee within a maximum of six months
- Having various diseases that may adversely affect performing balance exercises,
Sites / Locations
- Cukurova University, Faculty of Medicine, Physical Medicine and Rehabilitation Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Balance exercises and information
Information
Arm Description
Balance exercises six weeks and three days in a week and information about central sensitisation.
Information about central sensitisation.
Outcomes
Primary Outcome Measures
Central Sensitization Inventory (CSI)
CSI consists of 2 parts as A and B. Part A contains 25 items associated with central sensitization symptoms, and the person is asked to score each item between 0 (never) and 4 (always) and total score ranges from 0-100. It is accepted that there is central sensitization in individuals over 40 points. Part B consists of 10 diseases. In this section, it is questioned whether she was diagnosed one or more of these 10 diseases. If any of these diseases exist, the person is excluded from the study.
Secondary Outcome Measures
Berg Balance Scale (BBS)
In this scale, the patient is asked to perform 14 different activities. Every activity is scored between 0 (the worst)- 4 (the best) and a maximum of 56 points can be obtained.There is a correct proportion between the height of the score obtained and the balance.
Western Ontario ve McMaster University Osteoarthritis Index (WOMAC)
It consists of three sections as pain, stiffness and physical function and a total of 24 questions and scoring for each question as 0 = none, 1 = mild, 2 = medium, 3 = severe, 4 = very severe. Total WOMAC rate increases as pain, stiffness and physical function deterioration increase
Y Balance Test
Y Balance Test was used to assess the dynamic balance. This test is inexpensive and easy to transport which can be administered by therapists with different expertise and has been shown to have high reliability. In this test, patient exerts an effort to reach maximum distance in three different directions with the one leg while standing on the other leg.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04308967
Brief Title
Central Sensitization in Knee Osteoarthritis
Official Title
Effects of Balance Exercises on Central Sensitization in Patients With Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 20, 2020 (Actual)
Primary Completion Date
April 20, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The stimuli that activate nociceptors cause the dorsal horn of the spinal cord neurons to be sensitive to low-intensive afferent stimuli by decreasing the excitation threshold in patients with osteoarthritis. Although painful stimuli disappear, this situation causes pain to continue and a decrease in quality of life. Therefore, central sensitization should be considered and treated in patients with osteoarthritis. Although various pharmacological and electrophysiological agents are used in the treatment of central sensitization, adequate efficacy is not provided in patients with osteoarthritis. The aim of this study is to investigate the effects of balance exercises on central sensitization in patients with knee osteoarthritis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee, Central Sensitisation
Keywords
central sensitisation, osteoarthritis, balance exercises
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Balance exercises and information
Arm Type
Experimental
Arm Description
Balance exercises six weeks and three days in a week and information about central sensitisation.
Arm Title
Information
Arm Type
No Intervention
Arm Description
Information about central sensitisation.
Intervention Type
Other
Intervention Name(s)
balance exercises
Intervention Description
Three-stage progressive balance exercises will be applied.
Primary Outcome Measure Information:
Title
Central Sensitization Inventory (CSI)
Description
CSI consists of 2 parts as A and B. Part A contains 25 items associated with central sensitization symptoms, and the person is asked to score each item between 0 (never) and 4 (always) and total score ranges from 0-100. It is accepted that there is central sensitization in individuals over 40 points. Part B consists of 10 diseases. In this section, it is questioned whether she was diagnosed one or more of these 10 diseases. If any of these diseases exist, the person is excluded from the study.
Time Frame
Before intervention, change in CSI scores at sixth week, change in CSI scores at 3 months.
Secondary Outcome Measure Information:
Title
Berg Balance Scale (BBS)
Description
In this scale, the patient is asked to perform 14 different activities. Every activity is scored between 0 (the worst)- 4 (the best) and a maximum of 56 points can be obtained.There is a correct proportion between the height of the score obtained and the balance.
Time Frame
Before intervention, change in BBS scores at sixth week, change in BBS scores at 3 months.
Title
Western Ontario ve McMaster University Osteoarthritis Index (WOMAC)
Description
It consists of three sections as pain, stiffness and physical function and a total of 24 questions and scoring for each question as 0 = none, 1 = mild, 2 = medium, 3 = severe, 4 = very severe. Total WOMAC rate increases as pain, stiffness and physical function deterioration increase
Time Frame
Before intervention, change in WOMAC scores at sixth week, change in WOMAC scores at 3 months.
Title
Y Balance Test
Description
Y Balance Test was used to assess the dynamic balance. This test is inexpensive and easy to transport which can be administered by therapists with different expertise and has been shown to have high reliability. In this test, patient exerts an effort to reach maximum distance in three different directions with the one leg while standing on the other leg.
Time Frame
Before intervention, change in Y balance test scores at sixth week, change in Y balance test scores at 3 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Being diagnosed with primary knee osteoarthritis according to American College of Rheumatology criteria,
To be stage 2-3-4 knee osteoarthritis according to Kellgren Lawrence radiological staging,
To be with a central sensitization score of over 40 according to the CSI,
To be able to fill the scales and accept to participate in the study.
Exclusion Criteria:
Being diagnosed with secondary osteoarthritis or inflammatory rheumatic disease,
Having cognitive impairment,
To have been treated with physiotherapy, with an intra articular injection or with a surgery from the knee within a maximum of six months
Having various diseases that may adversely affect performing balance exercises,
Facility Information:
Facility Name
Cukurova University, Faculty of Medicine, Physical Medicine and Rehabilitation Clinic
City
Adana
ZIP/Postal Code
01100
Country
Turkey
12. IPD Sharing Statement
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Central Sensitization in Knee Osteoarthritis
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