NCT03245073

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

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

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

July 20, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 10, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

September 15, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2019

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2019

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

1.7 years

First QC Date

July 20, 2017

Last Update Submit

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 COMPARATOR

Strengthening and stretching exercises for hip and knee muscles, balance and proprioceptive exercises

Other: Exercise

Action observation therapy and exercise

EXPERIMENTAL

Video of normal human movement and Strengthening and stretching exercises for hip and knee muscles

Other: Action observation therapyOther: Exercise

Interventions

The normal human movement will be recorded and than the patients will be watched them.

Action observation therapy and exercise

Strengthening and stretching exercise programme focuses on hip and knee muscles

Action observation therapy and exerciseExercise

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

MeSH Terms

Conditions

Chronic PainOsteoarthritis, Knee

Interventions

Exercise

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsOsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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

Locations