knee Osteoarthritis. Osteoarthritis of knee
Conditions
Interventions
Intervention 1: Intervention group: Group 1: Comprehensive exercise + clinician’s positive pre-exercise interaction Group. group1 will receive 6-week Comprehensive exercise program. Prior to the first
Sponsors
Kharazmi University
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: Men and women aged 40 years or older a clinical diagnosis of knee Osteoarthritis (defined as knee pain for >3 months, early morning stiffness, crepitus, bony tenderness and no palpable warmth) in at least one knee radiographic grade 2 or 3 scored by the Kellgren and Lawrence (KL) scale in at least one knee pain from 3 to 7 on the Numerical Pain Rating Scale (NPRS) in at least one knee in the last week fluent in Persian (written and spoken)
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain: Perceived average pain. Timepoint: Baseline (T0), post-intervention (T1, 6 weeks), follow-up (T2, 3 months). Method of measurement: Numerical Pain Rating Scale (NPRS) is a valid and reliable in middle-aged adults with knee osteoarthritis. Participants will rate their average pain over the past week on an 11-point numeric scale ranging from: 0 = “No pain” and 10 = “Worst imaginable pain”. Following exercise therapy, a reduction of =1.5 points on the NPRS is considered clinically meaningful (MCID), with excellent test–retest reliability (ICC = 0.95) and strong construct validity (r = 0.93) compared to other pain scales.;Disability. Timepoint: Baseline (T0), post-intervention (T1, 6 weeks), follow-up (T2, 3 months). Method of measurement: The persian version of the WOMAC index (The Western Ontario and McMaster Universities Arthritis Index ) is used to assess pain, stiffness and physical activity as a reliable tool (ICC=0.99). It included 24 items: 5 questions about pain, 2 about stiffness and 17 about the level of physical activity in daily life. The score using an ordinal Likert scale of possible answers (0=strongly agree to 4=totally disagree). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. MCID ˜ 5.3, and ICC = 0.76 for WOMAC subscales. | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment Expectations. Timepoint: Baseline (T0), post-clinician interaction (T0.1, manipulation check), post-intervention (T1, 6 weeks), follow-up (T2, 3 months). Method of measurement: Treatment expectations regarding anticipated changes in pain will be assessed using a modified version of the Global Rating of Change (GROC) scale adapted for expectations. At baseline and immediately after the expectation modulation, participants will be asked: “After completing the assigned treatment, how much do you expect your pain to change?” Responses will be recorded on a 15-point scale, ranging from -7 (“much worse”) to 0 (“no change”) to +7 (“much better”).;Electromyographic (EMG). Timepoint: Muscle activity Baseline (T0), post-intervention (T1, 6 weeks), follow-up (T2, 3 months). Method of measurement: Electromyographic (EMG) assessment of muscle activity will be performed using an 8-channel system. active surface electrodes, Double differential, preamplifier electrodes will be placed over the belly of the following muscles of the leading foot of the lower extremity as per the recommended guidelines. EMG data will be collected during the three step-up trials performed as part of the kinematic assessment, and the EMG signals will be synchronized with the motion capture system and collected at 1080 Hz.A standing calibration trial will be used to define joint centers and create a segment coordinate system. Markers’ trajectories will be low-pass filtered at 6 Hz. EMG signals will be DC corrected and then band-pass, rectified, and adjusted for baseline noise by subtracting the mean of the rectified signal during the quiet period from the rectified signal. EMG amplitude will be normalized to the maximal activity from the dynamic trials, with the highest activity used for normalization.;Knee kinematics. Timepoint: Muscle activity Baseline (T0), post-intervention (T1, 6 weeks), follow-up (T2, 3 months). Method of measurement: Knee kinematics will be quantified during a step-up tas | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMaryam Bagheri Mahmoudi
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Outcome results
None listed