Central Sensitization in Knee Osteoarthritis

Osteo Arthritis Knee Clinical Trial

Official title:

Effects of Balance Exercises on Central Sensitization in Patients With Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04308967
• Other study ID #: 96/17
• Status: Completed
• Phase: N/A
• Start date: March 20, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: October 2022
• Source: Cukurova University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 30, 2021
• Est. primary completion date: April 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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,

Related Conditions & MeSH terms

• Central Sensitisation
• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• balance exercises
Three-stage progressive balance exercises will be applied.

Locations

Country	Name	City	State
Turkey	Cukurova University, Faculty of Medicine, Physical Medicine and Rehabilitation Clinic	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Before intervention, change in CSI scores at sixth week, change in CSI scores at 3 months.
Secondary	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.	Before intervention, change in BBS scores at sixth week, change in BBS scores at 3 months.
Secondary	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	Before intervention, change in WOMAC scores at sixth week, change in WOMAC scores at 3 months.
Secondary	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.	Before intervention, change in Y balance test scores at sixth week, change in Y balance test scores at 3 months.