A Phase 1 interventional study of MWM Treatment and MWM Sham in Osteoarthritis, sponsored by Imam Abdulrahman Bin Faisal University. Completed. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-12.
Sponsored by Imam Abdulrahman Bin Faisal University · Phase 1, Interventional, and Treatment
Osteoarthritis (OA) is the most prevalent form of arthritis and is reported to be the most important reason behind functional disability and musculoskeletal disorders among aged individuals. OA is "a total joint failure; represented by pathological damage to articular cartilage, that affects bone, menisci, synovium, ligaments, and neuromuscular tissue". Knee OA could be responsible for pain and functional disability in 19.2% of individuals aged more than 45 years in the Framingham study and in 27.8% of such individuals in the Johnston County Osteoarthritis Project. However, in the third National Health and Nutrition Examination Survey (NHANES III), nearly 37% of individuals aged 60 years or older had radiographic knee OA. Oliveria et al. (1995) reported that age- and sex-standardized incidence rates of symptomatic hip, knee, and hand OA were 88, 240, and 100/100,000 person-years, respectively. In addition, the incidence rates of symptomatic OA of the knee, hand, or hip increased rapidly at age 50 and then levelled off beyond age 70. There were not enough data to report the prevalence of OA in Arabic countries. However, a cross-sectional study performed in Saudi Arabia demonstrated radiographic knee OA in 53.3% of men and 60.9% of women, while about 18% of women and 10% of men had symptomatic OA. Although it is well established that OA is mainly caused by damage occurring in the joint because of degeneration and inflammation, there is no known cure for OA and our understanding of the pathological aetiology of OA is still deficient and poorly understood.
The primary objective of this study is to investigate the immediate and the carry-over effect of MWM on pain and function in patients with knee OA. A secondary objective is to evaluate this effect among those patients who demonstrate features of central sensitization.
Participants:
A power analysis was performed using G*Power 3.1 (F tests, analysis of variance [ANOVA]: repeated measure, within-between interaction, and a priori: compute required sample size). A result of 16 patients (treatment group = 8 and sham group = 8) was used to calculate an effect size (ES) of 0.27 for the pressure pain threshold of the knee after the intervention between groups. The power estimated for ANOVA for the two groups with a significance of 0.05 revealed that a total sample size of 27 patients was necessary to obtain a power of 0.80. Considering a 20% attrition rate, a minimum of 18 patients needed to be recruited for the first phase in this study.
Patients with knee OA who attended King Fahd Hospital of the University will be recruited for this study. Patients will be diagnosed at the orthopedic clinic and referred to the Department of Physiotherapy. Patients who are willing to participate in the study will be screened for their eligibility
Ethical considerations:
The study was approved by the Institutional Review Board (IRB) at the University of Dammam (IRB Number: IRB-2014-04-323). Eligible individuals for this study will be informed of the risks and benefits and will be asked to read and sign a written consent form.
Participant confidentiality will be maintained by using a code instead of the participant's name on the data collection form. All data collection forms will be saved in a file and secured in a locker. Only the researcher and the supervisor had a key to open this locker.
Statistical Analysis:
Data will be analyzed using International Business Machines (IBM) Statistical Package for Social Sciences (SPSS) for windows (version 20.0), significance level was set at p \< 0.05.
In phase 1, patients characteristics between groups at baseline will be analyzed using an independent t-test. One way ANOVA with repeated measures will be used to analyze the differences for other parametric data, Bonferroni adjustment will be used to compare main effects. Post-hoc tests will be performed to reveal differences of within- between groups over time (baseline, immediately post intervention, and after 2 days of intervention). For Likert-scale WOMAC, the Mann-Whitney U test will be used to investigate between-group analysis. Whereas, the Wilcoxon test will be used for within-group analysis. Further analysis to reveal correlations between the outcome measures will be investigated using Pearson Correlation test.
In phase 2, the groups are matched in age, gender, and BMI. The related t-test will be used to investigate differences between the groups.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 38 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Imam Abdulrahman Bin Faisal University is the lead sponsor of 88 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Mobilization with movement (MWM) is a combination of sustained passive accessory joint mobilization with an active or functional movement. MWM will be applied (three sets of 10 repetitions) during active knee flexion and extension range of motion (ROM). The therapist initially will apply the pain-free manual glide force on the tibia with the knee resting in a mid-range position. The glide force will be sustained while the patient performed 10 repetitions of self-active full range knee flexion and extension; overpressure was included at the end range.
Other: MWM Treatment
The patients will be handled similarly to MWM treatment group, except that they will not receive directional glide; instead, the physiotherapist's hands are just touch the knee skin without pressure; one hand on the tibia while the other hand on the femur. However, available active knee flexion and extension ROM will be performed (three sets of 10 repetitions).
Other: MWM Sham
Also known as: Mobilization with Movement, Manual therapy
The Visual Analog Scale (VAS)
Current pain intensity will be measured by a 10-cm line
Time frame: Change from Baseline in Visual Analog Scale at Immediate post-intervention
The Visual Analog Scale (VAS)
Current pain intensity will be measured by a 10-cm line
Time frame: Change from Baseline in Visual Analog Scale at 2 days
Western Ontario and McMaster Universities (WOMAC) Index
Self-administered questionnaire presented in Likert-scale format
Time frame: Change from Baseline in WOMAC at 2 days
Self-Leeds Assessment of Neuropathic Symptoms and signs (S-LANSS) Scale
A clinical-based instrument for identifying patients whose pain is dominated by neuropathic mechanisms
Time frame: At Baseline
Pressure Pain Threshold (PPT)
A digital pressure algometer will be used to quantify pain intensity in Kpa
Time frame: Change from Baseline in PPT at Immediate post-intervention
Pressure Pain Threshold (PPT)
A digital pressure algometer will be used to quantify pain intensity in Kpa
Time frame: Change from Baseline in PPT at 2 days
Thermal Perception and Pain Thresholds
A Thermotest System will be used to determine thermal thresholds in degree centigrade
Time frame: Change from Baseline in Thermal Perception and Pain Thresholds at Immediate post-intervention
Thermal Perception and Pain Thresholds
A Thermotest System will be used to determine thermal thresholds in degree centigrade
Time frame: Change from Baseline in Thermal Perception and Pain Thresholds at 2 days
Hand-Held Dynamometer
A digital instrument will be used to examine isometric muscle strength of force development in pound
Time frame: Change from Baseline in Hand-Held Dynamometer at Immediate post-intervention
Hand-Held Dynamometer
A digital instrument will be used to examine isometric muscle strength of force development for knee flexion and extension in pound
Time frame: Change from Baseline in Hand-Held Dynamometer at 2 days
Standard Goniometer
Active range of motion for knee flexion and extension in degree
Time frame: Change from Baseline in Standard Goniometer at Immediate post-intervention
Standard Goniometer
Active range of motion for knee flexion and extension in degree
Time frame: Change from Baseline in Standard Goniometer at 2 days
Three-meter Timed "Up and Go"
A walk test will be used to test a basic functional mobility
Time frame: Change from Baseline in Three-meter Timed "Up and Go" at Immediate post-intervention
Three-meter Timed "Up and Go"
A walk test will be used to test a basic functional mobility
Time frame: Change from Baseline in Three-meter Timed "Up and Go" at 2 days
No study locations are listed for this record.
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Imam Abdulrahman Bin Faisal University