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临床试验/NCT02865252
NCT02865252已完成1 期

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

Imam Abdulrahman Bin Faisal University0 个研究点目标入组 38 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
38
主要终点
Standard Goniometer

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Standard Goniometer

时间窗: Change from Baseline in Standard Goniometer at 2 days

Active range of motion for knee flexion and extension in degree

Thermal Perception and Pain Thresholds

时间窗: 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

Western Ontario and McMaster Universities (WOMAC) Index

时间窗: Change from Baseline in WOMAC at 2 days

Self-administered questionnaire presented in Likert-scale format

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

时间窗: At Baseline

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

Pressure Pain Threshold (PPT)

时间窗: Change from Baseline in PPT at 2 days

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

Hand-Held Dynamometer

时间窗: 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

Three-meter Timed "Up and Go"

时间窗: 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

The Visual Analog Scale (VAS)

时间窗: Change from Baseline in Visual Analog Scale at 2 days

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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