NCT04308967

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 16, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

March 20, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2021

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

October 12, 2022

Status Verified

October 1, 2022

Enrollment Period

1.1 years

First QC Date

March 12, 2020

Last Update Submit

October 7, 2022

Conditions

Osteo Arthritis KneeCentral Sensitisation

Keywords

central sensitisationosteoarthritisbalance exercises

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Berg Balance Scale (BBS)

    Before intervention, change in BBS scores at sixth week, change in BBS scores at 3 months.

  • Western Ontario ve McMaster University Osteoarthritis Index (WOMAC)

    Before intervention, change in WOMAC scores at sixth week, change in WOMAC scores at 3 months.

  • Y Balance Test

    Before intervention, change in Y balance test scores at sixth week, change in Y balance test scores at 3 months.

Study Arms (2)

Balance exercises and information

EXPERIMENTAL

Balance exercises six weeks and three days in a week and information about central sensitisation.

Other: balance exercises

Information

NO INTERVENTION

Information about central sensitisation.

Interventions

balance exercisesOTHER

Three-stage progressive balance exercises will be applied.

Balance exercises and information

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Adana, 01100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 12, 2020

First Posted

March 16, 2020

Study Start

March 20, 2020

Primary Completion

April 20, 2021

Study Completion

April 30, 2021

Last Updated

October 12, 2022

Record last verified: 2022-10

Locations

TU(1)