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NCT Number: NCT04308967

Central Sensitization in Knee Osteoarthritis

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.

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Key information

Conditions

Osteo Arthritis Knee Arthritis Central Sensitisation Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cukurova University, Faculty of Medicine, Physical Medicine and Rehabilitation Clinic

Adana, 01100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Balance Exercises

Other

Three-stage progressive balance exercises will be applied.

Primary outcomes

  1. Central Sensitization Inventory (CSI)

    Time frame: 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 outcomes

  1. Berg Balance Scale (BBS)

    Time frame: 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.

  2. Western Ontario ve McMaster University Osteoarthritis Index (WOMAC)

    Time frame: 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

  3. Y Balance Test

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 16, 2020
Registry last updated
Oct 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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