Clinical trial NCT02865252: The Effect of Mobilization With Movement on Pain and Function Among Patients With Knee Osteoarthritis
Official title: The Effect of Mobilization With Movement on Pain and Function Among Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoarthritis
Keywords: manual therapy
mobilization with movement
Lead sponsor: Imam Abdulrahman Bin Faisal University
Sponsor class: OTHER
First posted: 2016-08-12
Enrollment: 38
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Had unilateral or bilateral knee OA
* Knee OA K\&L grade ≥ 2
* VAS = 3 cm over the previous 24 hours
* Able to walk ≥ 6-meter distances with or without an aid

Exclusion Criteria:

* Had knee or lower limb surgery
* Oral corticosteroid use (current\\ 4 weeks)
* Altered sensation around knee and shoulder
* Exhibited cognitive difficulties
* Intra-articular corticosteroid or hyaluronic acid injection within 6 months
* Had leg sciatica
* Contraindication to manual therapy

Primary outcomes:
measure: The Visual Analog Scale (VAS)
timeFrame: Change from Baseline in Visual Analog Scale at Immediate post-intervention
measure: The Visual Analog Scale (VAS)
timeFrame: Change from Baseline in Visual Analog Scale at 2 days
measure: Western Ontario and McMaster Universities (WOMAC) Index
timeFrame: Change from Baseline in WOMAC at 2 days
measure: Self-Leeds Assessment of Neuropathic Symptoms and signs (S-LANSS) Scale
timeFrame: At Baseline
measure: Pressure Pain Threshold (PPT)
timeFrame: Change from Baseline in PPT at Immediate post-intervention
measure: Pressure Pain Threshold (PPT)
timeFrame: Change from Baseline in PPT at 2 days
measure: Thermal Perception and Pain Thresholds
timeFrame: Change from Baseline in Thermal Perception and Pain Thresholds at Immediate post-intervention
measure: Thermal Perception and Pain Thresholds
timeFrame: Change from Baseline in Thermal Perception and Pain Thresholds at 2 days
measure: Hand-Held Dynamometer
timeFrame: Change from Baseline in Hand-Held Dynamometer at Immediate post-intervention
measure: Hand-Held Dynamometer
timeFrame: Change from Baseline in Hand-Held Dynamometer at 2 days
measure: Standard Goniometer
timeFrame: Change from Baseline in Standard Goniometer at Immediate post-intervention
measure: Standard Goniometer
timeFrame: Change from Baseline in Standard Goniometer at 2 days
measure: Three-meter Timed "Up and Go"
timeFrame: Change from Baseline in Three-meter Timed "Up and Go" at Immediate post-intervention
measure: Three-meter Timed "Up and Go"
timeFrame: Change from Baseline in Three-meter Timed "Up and Go" at 2 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Imam Abdulrahman Bin Faisal University
name: Ali M Alshami, Ph.D
role: STUDY_DIRECTOR
References:
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citation: Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, Gabriel S, Hirsch R, Hochberg MC, Hunder GG, Jordan JM, Katz JN, Kremers HM, Wolfe F; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 2008 Jan;58(1):26-35. doi: 10.1002/art.23176.
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citation: Alkhawajah HA, Alshami AM. The effect of mobilization with movement on pain and function in patients with knee osteoarthritis: a randomized double-blind controlled trial. BMC Musculoskelet Disord. 2019 Oct 18;20(1):452. doi: 10.1186/s12891-019-2841-4.