Effects of Action Observation Therapy on Pain, Functional Level and Brain Hemodynamic in Patients With Knee Osteoarthritis
1 other identifier
interventional
30
1 country
1
Brief Summary
In this project, investigators aim to investigate the effects of action observation therapy on pain, fear of movement, functional level and brain hemodynamics in patients with knee osteoarthritis. The study is unique in that this method, which has already been used for post-surgical or motor healing, aims at long-term administration for the first time with chronic pain and objective visualization of the results. This study will create a new perspective to understand the physiology of pain, which has attracted much interest in the literature in recent years, and will shed light on the studies that can be done in this regard. Participants' joint range of motion in the initial assessments will be measured by electro-goniometer, muscle strength assessment by JTech hand dynamometer at appropriate evaluation positions. In assessing pain, pain levels at rest and during activity will be questioned using Visual Analog Scale. Fear of movement of individuals will be assessed via Tampa Kinesiophobia Scale and functional levels will be assessed via Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Timed Up and Go Test. Functional near infrared spectroscopy (fNIRS) will be used for evaluation of brain hemodynamics. The first group, will receive exercises with action observation therapy; and the second group will receive only exercises. The exercise programme will be administered under physiotherapist supervision for three days a week for six weeks. The evaluations will be repeated at the beginning of the study and at the end of the sixth week. Data obtained from the study will be analyzed using appropriate statistical methods.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2017
1 active site
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
July 20, 2017
CompletedFirst Posted
Study publicly available on registry
August 10, 2017
CompletedStudy Start
First participant enrolled
September 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 18, 2019
CompletedFebruary 11, 2020
February 1, 2020
1.7 years
July 20, 2017
February 7, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
Brain Hemodynamics
Functional near infrared spectroscopy will be used to assess the brain hemodynamics during the observation of actions, motor imagery and active movement.
6 weeks
Pressure pain threshold
Algometer (dolorimeter) will be used to assess the pressure pain threshold.
6 weeks
Visual Analog Scale
Self reported pain intensity during rest and walking measured by 0-10 point scale.
6 weeks
Other Outcomes (3)
Western Ontario and Mcmaster Universities Osteoarthritis Index
6 weeks
Kinesiophobia
6 weeks
Pain Catastrophization
6 weeks
Study Arms (2)
Exercise
ACTIVE COMPARATORStrengthening and stretching exercises for hip and knee muscles, balance and proprioceptive exercises
Action observation therapy and exercise
EXPERIMENTALVideo of normal human movement and Strengthening and stretching exercises for hip and knee muscles
Interventions
The normal human movement will be recorded and than the patients will be watched them.
Strengthening and stretching exercise programme focuses on hip and knee muscles
Eligibility Criteria
You may qualify if:
- Between 45 to 70 years;
- Unilateral knee osteoarthritis according to clinical and radiological criteria
- Grade 2 or Grade 3 according to Kellgren-Lawrance Scale
- Right-handed according to Edinburgh Handedness Scale
- Chronic pain during the rest or activity above 4 points according to the Verbal Rating Scale
You may not qualify if:
- Having neurological or psychiatric diseases
- Having chronic pain due to another pain disorder
- Having rheumatic diseases
- Using antidepressant medications or opioids
- Knee surgery within one year prior to the study
- Intraarticular injection and attend physical therapy within 6 months prior to the study
- Mini Mental State Examination Scale score below 24
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Haydarpasa Numune Training and Research Hospital
Istanbul, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
July 20, 2017
First Posted
August 10, 2017
Study Start
September 15, 2017
Primary Completion
May 15, 2019
Study Completion
May 18, 2019
Last Updated
February 11, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share