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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 20, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 12, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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