Central Sensitization in Knee Osteoarthritis

October 7, 2022 updated by: Emre Tirasci, Cukurova University

Effects of Balance Exercises on Central Sensitization in Patients With 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Adana, Turkey, 01100
        • Cukurova University, Faculty of Medicine, Physical Medicine and Rehabilitation Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Balance exercises and information
Balance exercises six weeks and three days in a week and information about central sensitisation.
Other: balance exercises
Three-stage progressive balance exercises will be applied.
NO_INTERVENTION: Information
Information about central sensitisation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before intervention, change in CSI scores at sixth week, change in CSI scores at 3 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before intervention, change in BBS scores at sixth week, change in BBS scores at 3 months.
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
Before intervention, change in WOMAC scores at sixth week, change in WOMAC scores at 3 months.
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.
Before intervention, change in Y balance test scores at sixth week, change in Y balance test scores at 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cukurova University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 20, 2020

Primary Completion (ACTUAL)

April 20, 2021

Study Completion (ACTUAL)

April 30, 2021

Study Registration Dates

First Submitted

March 12, 2020

First Submitted That Met QC Criteria

March 12, 2020

First Posted (ACTUAL)

March 16, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 12, 2022

Last Update Submitted That Met QC Criteria

October 7, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 96/17

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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