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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03792165
• Other study ID #: ATADEK 2017/8
• Status: Completed
• Phase: N/A
• Start date: February 11, 2019
• Est. completion date: July 10, 2019

Study information

• Verified date: July 2022
• Source: Acibadem University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Osteoarthritic joint has pathological changes such as damage of joint cartilage tissue, thickening of the subchondral bone, osteophyte formation, inflammation of synovium at different levels, degeneration of ligaments and meniscal structures and hypertrophy of joint capsule. Pain is the most common symptom in osteoarthritic patients and the ongoing pain effects quality of life and physical functions of them negatively. At the same time, decrease in joint range of motion, muscle strength loss and decline in functional level may go along with pain. In recent years, studies that relate chronic pain to neuroplasticity have demonstrated changes in the structure, function and somatotopic organization of the primary motor and sensory cortex of osteoarthritis patients with chronic pain. In addition to this, osteoarthritis studies showed that the pain does not originate solely from joint problems; the central nervous system is also responsible for the formation of pain sensation. Changes in the cortical sensorimotor areas include sensory disturbances, perceptual problems (differentiation of body image), and motor influences, and these changes are associated with severity and duration of pain. It is reported that approaches targeting cortical reorganization resulted in decreased pain and increased function. Action observation therapy is a method which activates mirror neurons and is applied to learn a specific motor skill, facilitate motor learning and decrease the pain level of the extremities. It is anticipated that action observation therapy may differentiate perception of pain by altering cortical activity and thus altered motor cortical activity may play an active role in reducing pain by modulating pain-related neural networks. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: July 10, 2019
• Est. primary completion date: July 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Action Observation Therapy
• Exercise
• Functional Near Infared Spectroscopy
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Action observation therapy
The normal human movement will be recorded and than the patients will be watched them.
• Exercise
Strengthening and stretching exercise programme focuses on hip and knee muscles

Locations

Country	Name	City	State
Turkey	Özgül Öztürk	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Acibadem University	Haydarpasa Numune Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Kinesiophobia	Tampa Kinesiophobia Scale will be used to assess the fear of movement. It is a 17-item self report checklist using a 4-point Likert scale that was developed as a measure of fear of movement or (re)injury. The total score ranges between 17 and 68. A high value on the TSK indicates a high degree of kinesiophobia.	6 weeks
Secondary	Western Ontario and Mcmaster Universities Osteoarthritis Index	WOMAC is used to assess pain, stiffness, and physical function in patients with knee osteoarthritis. Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing Stiffness (2 items): after first waking and later in the day Physical Function (17 items): stair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score.	6 weeks
Secondary	Muscle strength	Hand-held dynamometer will be used to evaluate knee and hip muscles' strength.	6 weeks
Secondary	Range of motion	Knee range of motion will be evaluated by digital goniometer. Knee flexion, knee extension, ankle dorsi and plantar flexion will be assessed.	6 weeks