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Completed

NCT Number: NCT02865252

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

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MWM Treatment

Other

Other names: Mobilization with Movement, Manual therapy

MWM Sham

Other

Primary outcomes

  1. The Visual Analog Scale (VAS)

    Time frame: Change from Baseline in Visual Analog Scale at Immediate post-intervention

    Current pain intensity will be measured by a 10-cm line

  2. The Visual Analog Scale (VAS)

    Time frame: Change from Baseline in Visual Analog Scale at 2 days

    Current pain intensity will be measured by a 10-cm line

  3. Western Ontario and McMaster Universities (WOMAC) Index

    Time frame: Change from Baseline in WOMAC at 2 days

    Self-administered questionnaire presented in Likert-scale format

  4. Self-Leeds Assessment of Neuropathic Symptoms and signs (S-LANSS) Scale

    Time frame: At Baseline

    A clinical-based instrument for identifying patients whose pain is dominated by neuropathic mechanisms

  5. Pressure Pain Threshold (PPT)

    Time frame: Change from Baseline in PPT at Immediate post-intervention

    A digital pressure algometer will be used to quantify pain intensity in Kpa

  6. Pressure Pain Threshold (PPT)

    Time frame: Change from Baseline in PPT at 2 days

    A digital pressure algometer will be used to quantify pain intensity in Kpa

  7. Thermal Perception and Pain Thresholds

    Time frame: Change from Baseline in Thermal Perception and Pain Thresholds at Immediate post-intervention

    A Thermotest System will be used to determine thermal thresholds in degree centigrade

  8. Thermal Perception and Pain Thresholds

    Time frame: Change from Baseline in Thermal Perception and Pain Thresholds at 2 days

    A Thermotest System will be used to determine thermal thresholds in degree centigrade

  9. Hand-Held Dynamometer

    Time frame: Change from Baseline in Hand-Held Dynamometer at Immediate post-intervention

    A digital instrument will be used to examine isometric muscle strength of force development in pound

  10. Hand-Held Dynamometer

    Time frame: Change from Baseline in Hand-Held Dynamometer at 2 days

    A digital instrument will be used to examine isometric muscle strength of force development for knee flexion and extension in pound

  11. Standard Goniometer

    Time frame: Change from Baseline in Standard Goniometer at Immediate post-intervention

    Active range of motion for knee flexion and extension in degree

  12. Standard Goniometer

    Time frame: Change from Baseline in Standard Goniometer at 2 days

    Active range of motion for knee flexion and extension in degree

  13. Three-meter Timed "Up and Go"

    Time frame: Change from Baseline in Three-meter Timed "Up and Go" at Immediate post-intervention

    A walk test will be used to test a basic functional mobility

  14. Three-meter Timed "Up and Go"

    Time frame: Change from Baseline in Three-meter Timed "Up and Go" at 2 days

    A walk test will be used to test a basic functional mobility

Sponsors and collaborators

Lead sponsor

Imam Abdulrahman Bin Faisal University

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
First posted
Aug 12, 2016
Registry last updated
Aug 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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