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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02865252
• Other study ID #: IRB-2014-04-323
• Status: Completed
• Phase: Phase 1
• First received: August 8, 2016
• Last updated: August 11, 2016
• Start date: October 2015

Study information

• Verified date: August 2016
• Source: Dammam University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ministry for Higher Education
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

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

Intervention

Other:
• MWM Treatment

• MWM Sham

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dammam University

References & Publications (10)

Al-Arfaj A, Al-Boukai AA. Prevalence of radiographic knee osteoarthritis in Saudi Arabia. Clin Rheumatol. 2002 May;21(2):142-5. — View Citation

Alghamdi MA, Olney S, Costigan P. Exercise treatment for osteoarthritis disability. Ann Saudi Med. 2004 Sep-Oct;24(5):326-31. Review. — View Citation

Creamer P, Hochberg MC. Osteoarthritis. Lancet. 1997 Aug 16;350(9076):503-8. Review. — View 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. — View 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. — View 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. — View 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: — View Citation

Kidd BL. Osteoarthritis and joint pain. Pain. 2006 Jul;123(1-2):6-9. Epub 2006 May 22. Review. — View 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 condition — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Visual Analog Scale (VAS)	Current pain intensity will be measured by a 10-cm line	Change from Baseline in Visual Analog Scale at Immediate post-intervention	No
Primary	The Visual Analog Scale (VAS)	Current pain intensity will be measured by a 10-cm line	Change from Baseline in Visual Analog Scale at 2 days	No
Primary	Western Ontario and McMaster Universities (WOMAC) Index	Self-administered questionnaire presented in Likert-scale format	Change from Baseline in WOMAC at 2 days	No
Primary	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	At Baseline	No
Primary	Pressure Pain Threshold (PPT)	A digital pressure algometer will be used to quantify pain intensity in Kpa	Change from Baseline in PPT at Immediate post-intervention	No
Primary	Pressure Pain Threshold (PPT)	A digital pressure algometer will be used to quantify pain intensity in Kpa	Change from Baseline in PPT at 2 days	No
Primary	Thermal Perception and Pain Thresholds	A Thermotest System will be used to determine thermal thresholds in degree centigrade	Change from Baseline in Thermal Perception and Pain Thresholds at Immediate post-intervention	No
Primary	Thermal Perception and Pain Thresholds	A Thermotest System will be used to determine thermal thresholds in degree centigrade	Change from Baseline in Thermal Perception and Pain Thresholds at 2 days	No
Primary	Hand-Held Dynamometer	A digital instrument will be used to examine isometric muscle strength of force development in pound	Change from Baseline in Hand-Held Dynamometer at Immediate post-intervention	No
Primary	Hand-Held Dynamometer	A digital instrument will be used to examine isometric muscle strength of force development for knee flexion and extension in pound	Change from Baseline in Hand-Held Dynamometer at 2 days	No
Primary	Standard Goniometer	Active range of motion for knee flexion and extension in degree	Change from Baseline in Standard Goniometer at Immediate post-intervention	No
Primary	Standard Goniometer	Active range of motion for knee flexion and extension in degree	Change from Baseline in Standard Goniometer at 2 days	No
Primary	Three-meter Timed "Up and Go"	A walk test will be used to test a basic functional mobility	Change from Baseline in Three-meter Timed "Up and Go" at Immediate post-intervention	No
Primary	Three-meter Timed "Up and Go"	A walk test will be used to test a basic functional mobility	Change from Baseline in Three-meter Timed "Up and Go" at 2 days	No