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

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
MWM Treatment
MWM Sham
Sponsored by
Imam Abdulrahman Bin Faisal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring manual therapy, mobilization with movement

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    MWM treatment

    MWM sham

    Arm Description

    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.

    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).

    Outcomes

    Primary Outcome Measures

    The Visual Analog Scale (VAS)
    Current pain intensity will be measured by a 10-cm line
    The Visual Analog Scale (VAS)
    Current pain intensity will be measured by a 10-cm line
    Western Ontario and McMaster Universities (WOMAC) Index
    Self-administered questionnaire presented in Likert-scale format
    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
    Pressure Pain Threshold (PPT)
    A digital pressure algometer will be used to quantify pain intensity in Kpa
    Pressure Pain Threshold (PPT)
    A digital pressure algometer will be used to quantify pain intensity in Kpa
    Thermal Perception and Pain Thresholds
    A Thermotest System will be used to determine thermal thresholds in degree centigrade
    Thermal Perception and Pain Thresholds
    A Thermotest System will be used to determine thermal thresholds in degree centigrade
    Hand-Held Dynamometer
    A digital instrument will be used to examine isometric muscle strength of force development in pound
    Hand-Held Dynamometer
    A digital instrument will be used to examine isometric muscle strength of force development for knee flexion and extension in pound
    Standard Goniometer
    Active range of motion for knee flexion and extension in degree
    Standard Goniometer
    Active range of motion for knee flexion and extension in degree
    Three-meter Timed "Up and Go"
    A walk test will be used to test a basic functional mobility
    Three-meter Timed "Up and Go"
    A walk test will be used to test a basic functional mobility

    Secondary Outcome Measures

    Full Information

    First Posted
    August 8, 2016
    Last Updated
    August 11, 2016
    Sponsor
    Imam Abdulrahman Bin Faisal University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02865252
    Brief Title
    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

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2015 (undefined)
    Primary Completion Date
    June 2016 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Imam Abdulrahman Bin Faisal University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis
    Keywords
    manual therapy, mobilization with movement

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    38 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MWM treatment
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    MWM sham
    Arm Type
    Sham Comparator
    Arm Description
    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).
    Intervention Type
    Other
    Intervention Name(s)
    MWM Treatment
    Other Intervention Name(s)
    Mobilization with Movement, Manual therapy
    Intervention Type
    Other
    Intervention Name(s)
    MWM Sham
    Primary Outcome Measure Information:
    Title
    The Visual Analog Scale (VAS)
    Description
    Current pain intensity will be measured by a 10-cm line
    Time Frame
    Change from Baseline in Visual Analog Scale at Immediate post-intervention
    Title
    The Visual Analog Scale (VAS)
    Description
    Current pain intensity will be measured by a 10-cm line
    Time Frame
    Change from Baseline in Visual Analog Scale at 2 days
    Title
    Western Ontario and McMaster Universities (WOMAC) Index
    Description
    Self-administered questionnaire presented in Likert-scale format
    Time Frame
    Change from Baseline in WOMAC at 2 days
    Title
    Self-Leeds Assessment of Neuropathic Symptoms and signs (S-LANSS) Scale
    Description
    A clinical-based instrument for identifying patients whose pain is dominated by neuropathic mechanisms
    Time Frame
    At Baseline
    Title
    Pressure Pain Threshold (PPT)
    Description
    A digital pressure algometer will be used to quantify pain intensity in Kpa
    Time Frame
    Change from Baseline in PPT at Immediate post-intervention
    Title
    Pressure Pain Threshold (PPT)
    Description
    A digital pressure algometer will be used to quantify pain intensity in Kpa
    Time Frame
    Change from Baseline in PPT at 2 days
    Title
    Thermal Perception and Pain Thresholds
    Description
    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
    Title
    Thermal Perception and Pain Thresholds
    Description
    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
    Title
    Hand-Held Dynamometer
    Description
    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
    Title
    Hand-Held Dynamometer
    Description
    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
    Title
    Standard Goniometer
    Description
    Active range of motion for knee flexion and extension in degree
    Time Frame
    Change from Baseline in Standard Goniometer at Immediate post-intervention
    Title
    Standard Goniometer
    Description
    Active range of motion for knee flexion and extension in degree
    Time Frame
    Change from Baseline in Standard Goniometer at 2 days
    Title
    Three-meter Timed "Up and Go"
    Description
    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
    Title
    Three-meter Timed "Up and Go"
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ali M Alshami, Ph.D
    Organizational Affiliation
    Imam Abdulrahman Bin Faisal University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    9274595
    Citation
    Creamer P, Hochberg MC. Osteoarthritis. Lancet. 1997 Aug 16;350(9076):503-8. doi: 10.1016/S0140-6736(97)07226-7. No abstract available.
    Results Reference
    background
    PubMed Identifier
    16714085
    Citation
    Kidd BL. Osteoarthritis and joint pain. Pain. 2006 Jul;123(1-2):6-9. doi: 10.1016/j.pain.2006.04.009. Epub 2006 May 22. No abstract available.
    Results Reference
    background
    PubMed Identifier
    15573841
    Citation
    Alghamdi MA, Olney S, Costigan P. Exercise treatment for osteoarthritis disability. Ann Saudi Med. 2004 Sep-Oct;24(5):326-31. doi: 10.5144/0256-4947.2004.326.
    Results Reference
    background
    PubMed Identifier
    18310746
    Citation
    Gwilym SE, Pollard TC, Carr AJ. Understanding pain in osteoarthritis. J Bone Joint Surg Br. 2008 Mar;90(3):280-7. doi: 10.1302/0301-620X.90B3.20167.
    Results Reference
    background
    PubMed Identifier
    19059028
    Citation
    Gross KD, Hillstrom H. Knee osteoarthritis: primary care using noninvasive devices and biomechanical principles. Med Clin North Am. 2009 Jan;93(1):179-200, xii. doi: 10.1016/j.mcna.2008.09.007.
    Results Reference
    background
    PubMed Identifier
    3632732
    Citation
    Felson DT, Naimark A, Anderson J, Kazis L, Castelli W, Meenan RF. The prevalence of knee osteoarthritis in the elderly. The Framingham Osteoarthritis Study. Arthritis Rheum. 1987 Aug;30(8):914-8. doi: 10.1002/art.1780300811.
    Results Reference
    result
    PubMed Identifier
    17216685
    Citation
    Jordan JM, Helmick CG, Renner JB, Luta G, Dragomir AD, Woodard J, Fang F, Schwartz TA, Abbate LM, Callahan LF, Kalsbeek WD, Hochberg MC. Prevalence of knee symptoms and radiographic and symptomatic knee osteoarthritis in African Americans and Caucasians: the Johnston County Osteoarthritis Project. J Rheumatol. 2007 Jan;34(1):172-80.
    Results Reference
    result
    PubMed Identifier
    18163497
    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.
    Results Reference
    result
    PubMed Identifier
    7639811
    Citation
    Oliveria SA, Felson DT, Reed JI, Cirillo PA, Walker AM. Incidence of symptomatic hand, hip, and knee osteoarthritis among patients in a health maintenance organization. Arthritis Rheum. 1995 Aug;38(8):1134-41. doi: 10.1002/art.1780380817.
    Results Reference
    result
    PubMed Identifier
    12086165
    Citation
    Al-Arfaj A, Al-Boukai AA. Prevalence of radiographic knee osteoarthritis in Saudi Arabia. Clin Rheumatol. 2002 May;21(2):142-5. doi: 10.1007/s10067-002-8273-8.
    Results Reference
    result
    PubMed Identifier
    31627723
    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.
    Results Reference
    derived

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

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