The Effect of Graded Motor Imagery on Pain and Function in Individuals With Knee Osteoarthritis

NCT05925517 | Completed

• 1 other identifier: Graded Motor Imagery
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis; Limitation, Mobility

Keywords

Pain; Knee Joint; Exercise; Range of Motion; Muscle Strength

Outcome Measures

Primary Outcomes (9)

• Pain Intensity

  Visual Analogue Scale (VAS) will be used to evaluate the severity of pain felt around the knee joint. Participants will be asked to mark the severity of the pain they feel (rest, activity and night) on a 10 cm horizontal line, from 0 (no pain) to 10 (unbearable pain).

  Baseline

• Pain Intensity

  Visual Analogue Scale (VAS) will be used to evaluate the severity of pain felt around the knee joint. Participants will be asked to mark the severity of the pain they feel (rest, activity and night) on a 10 cm horizontal line, from 0 (no pain) to 10 (unbearable pain).

  After the 8-week intervention

• Pain Intensity

  Visual Analogue Scale (VAS) will be used to evaluate the severity of pain felt around the knee joint. Participants will be asked to mark the severity of the pain they feel (rest, activity and night) on a 10 cm horizontal line, from 0 (no pain) to 10 (unbearable pain).

  6-week follow-up

• Pain Pressure Threshold

  The pain pressure threshold will be measured using a algometer. The pain pressure threshold will be evaluated at two points while the patient is lying in a lateral position: 1. point located 2 cm below the medial edge of the patella, and 2. point located 2 cm below the lateral edge of the patella. The evaluator will position the algometer perpendicular to each point and apply gradual pressure at a constant rate of approximately 0.5 kg/cm2/s. The pressure will be increased until the participant reports feeling pain. Each point considered for analysis will be assessed three times, and the average value will be recorded.

  Baseline

• Pain Pressure Threshold

  The pain pressure threshold will be measured using a algometer. The pain pressure threshold will be evaluated at two points while the patient is lying in a lateral position: 1. point located 2 cm below the medial edge of the patella, and 2. point located 2 cm below the lateral edge of the patella. The evaluator will position the algometer perpendicular to each point and apply gradual pressure at a constant rate of approximately 0.5 kg/cm2/s. The pressure will be increased until the participant reports feeling pain. Each point considered for analysis will be assessed three times, and the average value will be recorded.

  After the 8-week intervention

• Pain Pressure Threshold

  The pain pressure threshold will be measured using a algometer. The pain pressure threshold will be evaluated at two points while the patient is lying in a lateral position: 1. point located 2 cm below the medial edge of the patella, and 2. point located 2 cm below the lateral edge of the patella. The evaluator will position the algometer perpendicular to each point and apply gradual pressure at a constant rate of approximately 0.5 kg/cm2/s. The pressure will be increased until the participant reports feeling pain. Each point considered for analysis will be assessed three times, and the average value will be recorded.

  6-week follow-up

• WOMAC Pain Subscale

  The subscale can take a score between 0-20 and evaluates pain during walking on flat ground, going up and down stairs, standing, sitting and lying down.

  Baseline

• WOMAC Pain Subscale

  The subscale can take a score between 0-20 and evaluates pain during walking on flat ground, going up and down stairs, standing, sitting and lying down.

  After the 8-week intervention

• WOMAC Pain Subscale

  The subscale can take a score between 0-20 and evaluates pain during walking on flat ground, going up and down stairs, standing, sitting and lying down.

  6-week follow-up

Secondary Outcomes (15)

• Western Ontario and McMaster University Osteoarthritis Index (WOMAC)

  Baseline

• Western Ontario and McMaster University Osteoarthritis Index (WOMAC)

  After the 8-week intervention

• Western Ontario and McMaster University Osteoarthritis Index (WOMAC)

  6-week follow-up

• Range of Motion (ROM)

  Baseline

• Range of Motion (ROM)

  After the 8-week intervention

Study Arms (2)

Graded Motor Imagery

EXPERIMENTAL

Each patient in the Graded Motor Imagery group will receive a treatment protocol consisting of Graded Motor Imagery, conventional physiotherapy, and home exercises.

Other: Graded Motor Imagery (GMI); Other: Conventional Physiotherapy Program; Other: Home Exercise Protocol

Transcutaneous Electrical Nerve Stimulation (TENS)

ACTIVE COMPARATOR

Each patient in the Transcutaneous Electrical Nerve Stimulation group will receive a treatment protocol consisting of Transcutaneous Electrical Nerve Stimulation, conventional physiotherapy, and home exercises.

Other: Transcutaneous Electrical Nerve Stimulation (TENS); Other: Conventional Physiotherapy Program; Other: Home Exercise Protocol

Interventions

Graded Motor Imagery (GMI) OTHER

GMI includes three stages. Each session will be 30 minutes, and the GMI program will span over 8 weeks. The first 3 weeks will focus on lateralization, followed by 3 weeks of motor imagery, and the final 2 weeks will involve mirror therapy. Lateralization: Patients will be asked to differentiate whether the extremities shown in the Recognise™ Knee application belong to the right or left side of their body. Motor Imagery: Patients will be instructed to imagine slowly and smoothly moving their affected extremities to the posture depicted in the photos in the Recognise™ Knee application and then returning to the starting position. Mirror Therapy: Using a mirror measuring 90x60 cm² placed between the lower extremities, patients will be instructed to progressively move only their unaffected extremity, then their affected extremity, and finally both extremities.

Also known as: GMI

Graded Motor Imagery

Transcutaneous Electrical Nerve Stimulation (TENS) OTHER

Application will be performed using a TENS device and four separate 2 × 2 inch self-adhesive electrodes. The current will be applied to the most painful area of the affected knee. The four self-adhesive electrodes will be positioned in a square pattern, approximately 5 cm apart, centered over the pain point. Conventional TENS will be applied for 30 minutes at a frequency of 100 Hz, pulse width of 100 μs, and intensity below 10% of the motor threshold.

Also known as: TENS

Transcutaneous Electrical Nerve Stimulation (TENS)

Conventional Physiotherapy Program OTHER

The routine 60-minute program for OA patients in conventional physiotherapy includes warming up, core stability, pelvic and hip stability, gluteus medius strengthening, knee control and stability (knee flexion and extension control, lunge exercises), knee strengthening exercises (wall-assisted leg press with a ball, step-ups with elastic bands), and functional exercises.

Graded Motor Imagery; Transcutaneous Electrical Nerve Stimulation (TENS)

Home Exercise Protocol OTHER

The home exercises will include a warm-up consisting of a 10-minute walk at a normal pace on a flat surface while gently stretching the hamstring and calf muscles. The exercises will also involve straight leg raises, terminal knee extension, isometric contractions of the quadriceps femoris and adductor muscles using a pillow for support, toe raises, single-leg standing, toe taps, and quadriceps strengthening exercises included in the session.

Graded Motor Imagery; Transcutaneous Electrical Nerve Stimulation (TENS)

Eligibility Criteria

• Age: 45 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Artvin Coruh University: lead
• Marmara University: collaborator

Study Sites (1)

Artvin State Hospital

Artvin, 08000, Turkey (Türkiye)

Location

Related Publications (1)

• Kizkin ZY, Oguz S, Ak S. The Effect of Graded Motor Imagery on Pain and Function in Individuals With Knee Osteoarthritis: A Comparative Randomized Controlled Trial. Am J Phys Med Rehabil. 2025 Jun 1;104(6):534-543. doi: 10.1097/PHM.0000000000002663. Epub 2024 Nov 28.

  PMID: 39642317 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Mobility Limitation; Pain; Motor Activity

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Zeynep Yıldız Kızkın, PhD

  Artvin Coruh University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: In this prospective study, two treatment groups were formed to receive GMI and TENS.

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: June 29, 2023
• Study Start: July 1, 2023
• Primary Completion: February 15, 2024
• Study Completion: March 31, 2024
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)