Central Sensitization in Knee Osteoarthritis

Not Applicable

Completed

• Conditions: Osteo Arthritis Knee; Central Sensitisation
• Interventions: Other: balance exercises

• Registration Number: NCT04308967
• Lead Sponsor: Cukurova University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-12
• Study First Submitted QC: 2020-03-12
• Study First Posted: 2020-03-16
• Study Start: 2020-03-20
• Primary Completion: 2021-04-20
• Study Completion: 2021-04-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-07
• Last Update Posted: 2022-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Balance exercises and information	balance exercises	Balance exercises six weeks and three days in a week and information about central sensitisation.

Primary Outcome Measures

Name	Time	Method
Central Sensitization Inventory (CSI)	Before intervention, change in CSI scores at sixth week, change in CSI scores at 3 months.	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

Name	Time	Method
Western Ontario ve McMaster University Osteoarthritis Index (WOMAC)	Before intervention, change in WOMAC scores at sixth week, change in WOMAC scores at 3 months.	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
Berg Balance Scale (BBS)	Before intervention, change in BBS scores at sixth week, change in BBS scores at 3 months.	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.
Y Balance Test	Before intervention, change in Y balance test scores at sixth week, change in Y balance test scores at 3 months.	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.

Trial Locations

Locations (1)

Cukurova University, Faculty of Medicine, Physical Medicine and Rehabilitation Clinic; 🇹🇷 Adana, Turkey