The Effect of Mobilization With Movement on Pain and Function Among Patients With Knee Osteoarthritis

Osteoarthritis Clinical Trial

Official title: The Effect of Mobilization With Movement on Pain and Function Among Patients With Knee Osteoarthritis

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

• NCT number: NCT02865252
• Study type: Interventional
• Source: Dammam University
• Status: Completed
• Phase: Phase 1
• Start date: October 2015