This is a randomized controlled trial examining and compare the effects of open and closed kinetic chain exercises on pain, function, and cartilage synthesis and degradation biomarkers after an eight-week rehabilitation program for knee osteoarthritis (OA) patients.
Design and Subjects: A prospective, active control, three-parallel-group, assessor-blinded, randomized controlled trial. A sample of 120 subjects will be recruited and randomly assigned to one of three study groups at a 1:1:1 allocation ratio (40 participants per group): a) Standard care only, b) Closed kinetic chain exercises plus standard care, and c) Open kinetic chain plus standard care. Intervention: participants will receive 24 treatment sessions (3 sessions/week) over 8 weeks. Participants will be allocated to the experimental groups will receive the standard care protocol in addition to either closed or open-chain exercises. Outcome measures: The primary outcomes are physical function and pain assessed using the Western Ontario and McMaster Universities (WOMAC) scores. Secondary outcomes include the Numeric Pain Rating Scale, quadriceps and hamstring strength, joint range of motion (ROM), joint proprioception error, and serum and urine OA biomarkers including the Serum cartilage oligomeric matrix protein (COMP), Serum propeptide Type-II N-terminal (PIIANP), Serum C- reactive protein (CRP), and Urine type -II Collagen telopeptide (CTX-II). Data Analysis: Data will be analyzed using the intension-to-treat (ITT) analysis with multiple imputations. The primary analysis of the primary outcomes at a two-month follow-up time point (after completing the intervention protocol for 8 weeks) will be carried out using a mixed-model analysis of variance (ANOVA) test with adjustment for a set of pre-specified baseline factors. Secondary analysis using the ANOVA test for the primary outcomes at a six-month follow-up time point, and secondary outcomes at all follow-up time points will also be carried out.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
Patients assigned to this group will receive a 40-min multimodal supervised physical therapy treatment comprised of warm-up (10-min cycling/walking), muscle stretching, neuromuscular control exercises, and ten-minute transcutaneous electrical nerve stimulation (TENS). Manual mobilization techniques may be applied as necessary according to the findings of the physical examination. Treating physical therapists will prescribe exercises based on a predetermined list of exercises.
Patients assigned to this group will receive a 40-min multimodal supervised physical therapy treatment comprised of warm-up (10-min cycling/walking), three sets of 10 repetitions of 60% of one-repetition maximum (1RM) of seated leg press and partial squat exercises, neuromuscular control exercises, and ten-minute transcutaneous electrical nerve stimulation (TENS). Manual mobilization techniques may be applied as necessary according to the findings of the physical examination. Treating physical therapists will prescribe exercises based on a predetermined list of exercises.
King Fahd Military Medical Complex
Dammam, Saudi Arabia
RECRUITINGChange in pain score using the Arabic version of the Western Ontario and McMaster Universities (WOMAC) index
A 5-point Likert scale comprised of 24 questions across 3 subscales. Standardized answers are assigned a score from 0 (no symptoms) to 4 (extreme symptoms) with higher scores indicating worst pain, stiffness, and function.
Time frame: Baseline, 2, and 6 months follow-up
Change in function score using the Arabic version of the Western Ontario and McMaster Universities (WOMAC) index
A 5-point Likert scale comprised of 24 questions across 3 subscales. Standardized answers are assigned a score from 0 (no symptoms) to 4 (extreme symptoms) with higher scores indicating worst pain, stiffness, and function.
Time frame: Baseline, 2, and 6 months follow-up
Change in knee pain using the Arabic version of the Numeric Pain Rating Scale (ANPRS)
A horizontal 11-point scale (0-10), with 0 indicating no pain and 10 indicating the worst pain ever.
Time frame: Baseline, 2, and 6 months follow-up
Change in isometric muscle strength
Measured in Newtons for the Quadriceps and Hamstring muscles using a hand-held dynamometer (Commander Muscle testing, JTech, USA). The greater the recorded value the better the muscle strength.
Time frame: Baseline, 2, and 6 months follow-up
Change in knee joint range of motion (ROM)
Active knee joint flexion/extension ROM measured in degrees using an electric goniometer (Biometrics Ltd, DLK900, UK). The greater the recorded value the greater the knee joint ROM.
Time frame: Baseline, 2, and 6 months follow-up
Change in knee joint proprioception
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Patients assigned to this group will receive a 40-min multimodal supervised physical therapy treatment comprised of warm-up (10-min cycling/walking), three sets of 10 repetitions of 60% of one-repetition maximum (1RM) of Quadriceps seated strengthening and Hamstring curl-up exercises, neuromuscular control exercises, and ten-minute transcutaneous electrical nerve stimulation (TENS). Manual mobilization techniques may be applied as necessary according to the findings of the physical examination. Treating physical therapists will prescribe exercises based on a predetermined list of exercises.
Active repositioning error of a given passive position of the knee joint will be assessed using an electric goniometer (Biometrics Ltd, DLK900, UK). The lesser the recorded value the better the knee joint proprioception.
Time frame: Baseline, 2, and 6 months follow-up
Change in knee OA biomarkers
Serum (10 ml blood) and urine samples will be collected from the participants and analyzed using the Enzyme-linked immunosorbent assay (ELISA) technique.
Time frame: Baseline, 2, and 6 months follow-up