Clinical trial NCT05925517: The Effect of Graded Motor Imagery on Pain and Function in Individuals With Knee Osteoarthritis
Official title: The Effect of Graded Motor Imagery on Pain and Function in Individuals With Knee Osteoarthritis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Limitation, Mobility
Keywords: Pain
Knee Joint
Exercise
Range of Motion
Muscle Strength
Lead sponsor: Artvin Coruh University
Sponsor class: OTHER
Collaborators: name: Marmara University
First posted: 2023-06-29
Enrollment: 46
Sex: ALL
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this prospective study, two treatment groups were formed to receive GMI and TENS.
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate whether Graded Motor Imagery (GMI) application is as effective as Transcutaneous Electrical Nerve Stimulation (TENS) in individuals with knee osteoarthritis (OA). The objectives are to improve range of motion (ROM) and muscle strength, reduce pain and stiffness, increase pain pressure threshold, and enhance function and physical performance through GMI application.

Detailed description: 46 voluntary patients with knee OA, aged between 45-64 years will be randomly divided into two groups: GMI group and TENS group. Interventions will be applied for 8 weeks, 3 times a week (24 sessions). Both groups will receive conventional physiotherapy and home exercises in addition to GMI or TENS treatment. The patients will be assessed before, after treatment and six-week follow-up. Knee pain will be evaluated using the Visual Analog Scale (VAS), pressure pain threshold will be measured using an algometer, pain, function, and stiffness will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), active knee range of motion will be measured using a digital goniometer, muscle strength will be evaluated using a hand-held dynamometer, and function will be assessed using the Timed Up and Go Test.

Eligibility criteria: Inclusion Criteria:

* Minimum score of 24 on the Mini Mental State Examination (indicating no mild or severe dementia)
* Diagnosis of moderate unilateral knee osteoarthritis persisting for more than 12 months according to American College of Rheumatology (ACR) criteria
* Experience of pain with a severity rating of 3 or higher on the Visual Analog Scale (VAS) for activities such as stair climbing, sitting, and squatting, lasting for at least 6 months (moderate to severe pain)
* Age between 45 and 64 years
* Residing in the city where the study is conducted
* Ability to walk independently
* Presence of limitations in knee range of motion (ROM)
* Symptomatic and radiographically confirmed OA diagnosis of Kellgren and Lawrence grade I-III

Exclusion Criteria:

* Patients who are unwilling to participate in the study
* Patients presenting with secondary OA due to conditions such as rheumatoid arthritis, gout, septic arthritis, tuberculosis, tumor, trauma, hemophilia, major medical or psychiatric disorders, recent fractures, presence of effusion or open reduction and internal fixation in the knee
* Presence of a neuromuscular disease
* History of intra-articular injections in the past 6 months
* Patients undergoing medication changes
* Presence of any chronic illness that would hinder participation in the treatment program
* Participation in a physiotherapy program for OA in the last 12 weeks
* Movement limitations or limb deficiency in the contralateral lower extremity
* Presence of visual or hearing problems that would affect treatment adherence.

Primary outcomes:
measure: Pain Intensity
timeFrame: Baseline
measure: Pain Intensity
timeFrame: After the 8-week intervention
measure: Pain Intensity
timeFrame: 6-week follow-up
measure: Pain Pressure Threshold
timeFrame: Baseline
measure: Pain Pressure Threshold
timeFrame: After the 8-week intervention
measure: Pain Pressure Threshold
timeFrame: 6-week follow-up
measure: WOMAC Pain Subscale
timeFrame: Baseline
measure: WOMAC Pain Subscale
timeFrame: After the 8-week intervention
measure: WOMAC Pain Subscale
timeFrame: 6-week follow-up
Secondary outcomes:
measure: Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
timeFrame: Baseline
measure: Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
timeFrame: After the 8-week intervention
measure: Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
timeFrame: 6-week follow-up
measure: Range of Motion (ROM)
timeFrame: Baseline
measure: Range of Motion (ROM)
timeFrame: After the 8-week intervention
measure: Range of Motion (ROM)
timeFrame: 6-week follow-up
measure: Isometric Muscle Strength
timeFrame: Baseline
measure: Isometric Muscle Strength
timeFrame: After the 8-week intervention
measure: Isometric Muscle Strength
timeFrame: 6-week follow-up
measure: Mini Mental State Examination
timeFrame: Baseline
measure: Mini Mental State Examination
timeFrame: After the 8-week intervention
measure: Mini Mental State Examination
timeFrame: 6-week follow-up
measure: Timed Get Up and Go Test (TUG)
timeFrame: Baseline
measure: Timed Get Up and Go Test (TUG)
timeFrame: After the 8-week intervention
measure: Timed Get Up and Go Test (TUG)
timeFrame: 6-week follow-up
Other outcomes:
Locations:
city: Artvin
country: Turkey
facility: Artvin State Hospital
Study officials:
affiliation: Artvin Coruh University
name: Zeynep Yıldız Kızkın, PhD
role: PRINCIPAL_INVESTIGATOR
References: