Effects of Action Observation Therapy on Pain and Brain Hemodynamics in Patients With Knee Osteoarthritis

NCT03792165 | Completed

• 1 other identifier: ATADEK 2017/8
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to explore the effects of action observation therapy on pain and brain hemodynamics in patients with knee osteoarthritis. This study will create a new perspective to understand the physiology of pain, by applying painful stimulation during the neuroimaging system 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' pain level will be assessed using Visual Analog Scale and pressure algometer. Also 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. 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.

Conditions

Knee Osteoarthritis; Action Observation Therapy; Functional Near Infared Spectroscopy; Exercise

Outcome Measures

Primary Outcomes (3)

• Change in brain activation in dorsolateral prefrontal cortex as assessed by fNIRS monitoring (measure of hemodynamic response function)

  In order to assess the brain hemodynamics during the painful and non painful stimulations of patients functional near infrared spectroscopy (NIRX Medical Technologies NIRScout) will be used. This neuroimaging method will be applied with 16 detector and 16 source which implanted via a cap. Firstly, the patients' pain pressure threshold level at knee region will be determined, then this value will be considered as painful stimulation. For non-painful stimulation 5 N will be applied to the patient. Hemodynamic responses will be evaluated according to the cortical areas (prefrontal cortex, premotor and supplementary motor cortex, primer motor cortex, primer somatosensory cortex)

  6 weeks

• Pain Level

  Self reported pain intensity during the rest and the activity measured by Visual Analog Scale which presented as a 10 centimeter horizontal line and 0 means no pain, 10 means unbearable pain.

  6 weeks

• Pressure pain threshold

  Algometer (dolorimeter) will be used to assess the pressure pain threshold, whereby the medial middle point of the knee and 2 cm lateral to the medial malleol.

  6 weeks

Secondary Outcomes (4)

• Kinesiophobia

  6 weeks

• Western Ontario and Mcmaster Universities Osteoarthritis Index

  6 weeks

• Muscle strength

  6 weeks

• Range of motion

  6 weeks

Study Arms (2)

Action observation therapy and exercise

EXPERIMENTAL

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

Other: Action observation therapy; Other: Exercise

Exercise

ACTIVE COMPARATOR

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

Other: Exercise

Interventions

Action observation therapy OTHER

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

Action observation therapy and exercise

Exercise OTHER

Strengthening and stretching exercise programme focuses on hip and knee muscles

Action observation therapy and exercise; Exercise

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• MMSE\>21
• Chronic knee pain (VAS score\>5)
• Right dominant
• Unilateral knee pain

You may not qualify if:

• Pain characteristics such as the presence of a rheumatologic disease other than knee osteoarthritis, lumbar radiculopathy, systemic inflammatory disease, diabetic neuropathy, problems similar to knee osteoarthritis,
• Hearing or vision problems,
• Injection therapy involving the knee region within the last 6 months,
• Surgical operation involving the knee region
• Psychiatric problems and anti-depressant usage

Sponsors & Collaborators

• Acibadem University: lead
• Haydarpasa Numune Training and Research Hospital: collaborator

Study Sites (1)

Özgül Öztürk

Istanbul, 34752, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal 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: Lecturer

Study Record Dates

• First Submitted: December 28, 2018
• First Posted: January 3, 2019
• Study Start: February 11, 2019
• Primary Completion: July 8, 2019
• Study Completion: July 10, 2019
• Last Updated: July 18, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)