Central Sensitization in Knee Osteoarthritis

Sponsor
Cukurova University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04308967
Collaborator
(none)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: balance exercises
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effects of Balance Exercises on Central Sensitization in Patients With Knee Osteoarthritis
Anticipated Study Start Date :
Mar 20, 2020
Anticipated Primary Completion Date :
Sep 20, 2020
Anticipated Study Completion Date :
Nov 20, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Western Ontario ve McMaster University Osteoarthritis Index (WOMAC) [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

  2. Central Sensitization Inventory (CSI) [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 Outcome Measures

  1. Berg Balance Scale (BBS) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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,

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cukurova University, Faculty of Medicine, Physical Medicine and Rehabilitation Clinic Adana Turkey 01100

Sponsors and Collaborators

  • Cukurova University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Emre Tirasci, Principal Investigator, Cukurova University
ClinicalTrials.gov Identifier:
NCT04308967
Other Study ID Numbers:
  • 96/17
First Posted:
Mar 16, 2020
Last Update Posted:
Mar 19, 2020
Last Verified:
Mar 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Emre Tirasci, Principal Investigator, Cukurova University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 19, 2020