- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07767812
Effects of Motivational Interviewing on Pain Self-Efficacy and Exercise Behavior in Individuals With Knee Osteoarthritis
August 14, 2026 updated by: Ismail Saracoglu, Kutahya Health Sciences University
Investigation of the Effects of Motivational Interviewing on Pain Self-Efficacy and Exercise Behavior in Individuals With Knee Osteoarthritis
This randomized controlled trial aims to investigate the effects of motivational interviewing added to a neuromuscular exercise and home exercise program on pain self-efficacy, exercise behavior, pain intensity, physical performance, and functional status in individuals with knee osteoarthritis.
Sixty individuals diagnosed with knee osteoarthritis will be randomly allocated to either an intervention group or a control group.
The intervention group will receive motivational interviewing in addition to neuromuscular exercise and a home exercise program, whereas the control group will receive neuromuscular exercise and the same home exercise program.
Outcomes will be assessed at baseline, immediately after the intervention, and six weeks after the intervention.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
56
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: İbrahim YUKSEL, Msc. PT
- Phone Number: 0539 222 88 46
- Email: ibrahimyuksel0308@gmail.com
Study Locations
-
-
Türkiye
-
Afyonkarahisar, Türkiye, Turkey (Türkiye), 03100
- Recruiting
- AFSÜ Health Application and Research Center, Department of Physical Therapy and Rehabilitation
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Contact:
- Aynur EYVAZ, MD
- Phone Number: 00902742651100
- Email: aynureyvaz@afsu.edu.tr
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Principal Investigator:
- İbrahim YUKSEL, Msc.
-
Principal Investigator:
- Ismail Saracoglu, Phd
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Sub-Investigator:
- Nuray EYVAZ, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Diagnosis of knee osteoarthritis according to American College of Rheumatology (ACR) criteria
- Kellgren-Lawrence radiographic grade ≥2
- Knee pain lasting longer than 3 months
Exclusion Criteria:
- History of joint arthroplasty
- Body mass index >40 kg/m²
- Neuromuscular or neurological diseases such as stroke, Parkinson's disease, or multiple sclerosis
- History of lower-extremity joint fracture
- Hip osteoarthritis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Motivational Interviewing + Neuromuscular Exercise + Home Exercise
Participants in this group will receive motivational interviewing in addition to a supervised neuromuscular exercise program and a home exercise program.
|
Motivational interviewing will be delivered individually in face-to-face sessions by a researcher trained and certified in motivational interviewing.
Sessions will focus on identifying individual barriers and goals, strengthening motivation and commitment to exercise, supporting self-efficacy, and preventing relapse.
The intervention will incorporate three stages: increasing exercise motivation, strengthening commitment to exercise, and relapse prevention.
Participants will perform neuromuscular exercise sessions five times per week for four weeks.
Each 60-minute session will consist of approximately 10 minutes of warm-up, 40 minutes of exercise, and 10 minutes of cool-down.
Exercises will include core stabilization and postural control, postural orientation, lower-extremity strengthening, functional exercises, and balance and proprioception exercises.
Exercises will be progressed according to participant tolerance and functional performance.
The home exercise program will include isometric strengthening exercises for the quadriceps and hip adductor muscles, straight leg raising, assisted hip and knee flexion, and active knee flexion exercises.
Participants will perform the program five days per week, twice daily, for three weeks, with 10 repetitions of each exercise.
The program will be explained and demonstrated by a physiotherapist during the first session, and adherence will be followed by telephone contact.
|
|
Active Comparator: Neuromuscular Exercise Program
Participants will perform neuromuscular exercise sessions five times per week for four weeks.
Each 60-minute session will consist of approximately 10 minutes of warm-up, 40 minutes of exercise, and 10 minutes of cool-down.
Exercises will include core stabilization and postural control, postural orientation, lower-extremity strengthening, functional exercises, and balance and proprioception exercises.
Exercises will be progressed according to participant tolerance and functional performance.
|
Participants will perform neuromuscular exercise sessions five times per week for four weeks.
Each 60-minute session will consist of approximately 10 minutes of warm-up, 40 minutes of exercise, and 10 minutes of cool-down.
Exercises will include core stabilization and postural control, postural orientation, lower-extremity strengthening, functional exercises, and balance and proprioception exercises.
Exercises will be progressed according to participant tolerance and functional performance.
The home exercise program will include isometric strengthening exercises for the quadriceps and hip adductor muscles, straight leg raising, assisted hip and knee flexion, and active knee flexion exercises.
Participants will perform the program five days per week, twice daily, for three weeks, with 10 repetitions of each exercise.
The program will be explained and demonstrated by a physiotherapist during the first session, and adherence will be followed by telephone contact.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Exercise Self-Efficacy Scale (ESE)
Time Frame: Baseline, immediately after the 4-week intervention, and 6 weeks after completion of the intervention
|
The Exercise Self-Efficacy Scale (ESE) measures a person's confidence in their ability to maintain regular physical activity or exercise when facing various internal and external barriers.
Different validated versions exist, including Albert Bandura's 18-item scale, an older adult 9-item scale, and a 10-item spinal cord injury adaptation.
|
Baseline, immediately after the 4-week intervention, and 6 weeks after completion of the intervention
|
|
Pain Self-Efficacy Questionnaire (PSEQ)
Time Frame: Baseline, immediately after the 4-week intervention, and 6 weeks after completion of the intervention
|
The Pain Self-Efficacy Questionnaire (PSEQ) is a 10-item self-report tool designed to measure a person's confidence in performing daily activities and functioning normally despite ongoing chronic pain.
It uses a 7-point scale from 0 to 6, yielding total scores between 0 and 60, where higher scores reflect stronger coping confidence.
|
Baseline, immediately after the 4-week intervention, and 6 weeks after completion of the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numerical Pain Rating Scale
Time Frame: Baseline, immediately after the 4-week intervention, and 6 weeks after completion of the intervention
|
The Numeric Pain Rating Scale (NPRs) is a fast, 11-point tool used to measure pain intensity.
Patients select a whole number from 0 (no pain) to 10 (worst pain imaginable) to rate their discomfort verbally or in writing.
|
Baseline, immediately after the 4-week intervention, and 6 weeks after completion of the intervention
|
|
The WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
Time Frame: Baseline, immediately after the 4-week intervention, and 6 weeks after completion of the intervention.
|
The WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) is a widely used, self-administered 24-item questionnaire that evaluates pain (5 items), stiffness (2 items), and physical function (17 items) in patients with knee or hip osteoarthritis.
|
Baseline, immediately after the 4-week intervention, and 6 weeks after completion of the intervention.
|
|
Physical Performance 30-Second Sit-to-Stand Test (30s STS)
Time Frame: Baseline, immediately after the 4-week intervention, and 6 weeks after completion of the intervention
|
The 30s STS measures lower-extremity functional strength by recording the total number of complete sit-to-stand repetitions performed within 30 seconds, with a higher number of repetitions indicating better performance.
|
Baseline, immediately after the 4-week intervention, and 6 weeks after completion of the intervention
|
|
Physical performance timed up and go test (TUG)
Time Frame: Baseline, immediately after 4 week intervention and 6 weeks after competition of the intervention
|
The TUG measures functional mobility as the time, in seconds, required to stand up from a chair, walk 3 meters, turn, walk back, and sit down, with a shorter completion time indicating better performance.
|
Baseline, immediately after 4 week intervention and 6 weeks after competition of the intervention
|
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Physical performance 40-meter Walking Test
Time Frame: Baseline, immediately after the 4-week intervention, and 6 weeks after completion of the intervention
|
The 40mWT assesses walking speed by recording the time required to complete a 40-meter walking course, with a shorter completion time indicating better walking performance.
The results of the three tests will be reported separately and will not be combined into a composite score.
|
Baseline, immediately after the 4-week intervention, and 6 weeks after completion of the intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2026
Primary Completion (Estimated)
November 15, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
August 11, 2026
First Submitted That Met QC Criteria
August 14, 2026
First Posted (Actual)
August 17, 2026
Study Record Updates
Last Update Posted (Actual)
August 17, 2026
Last Update Submitted That Met QC Criteria
August 14, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Musculoskeletal Diseases
- Arthritis
- Joint Diseases
- Rheumatic Diseases
- Osteoarthritis
- Behavior
- Osteoarthritis, Knee
- Motor Activity
- Health Services
- Health Care Facilities Workforce and Services
- Behavioral Disciplines and Activities
- Directive Counseling
- Counseling
- Mental Health Services
- Motivational Interviewing
Other Study ID Numbers
- IbrahimPHDtez
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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