Efficacy of Adding Mechanical Nonsurgical Knee Traction to Standard Physical Therapy Rehabilitation of Knee Osteoarthritis: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 198
- 主要终点
- Change in pain score using the Arabic version of the Knee Injury and Osteoarthritis Outcome Score (KOOS)
研究概览
简要总结
This is a randomized controlled trial examining the short- and long-term effects of mechanical nonsurgical knee joint traction on knee pain, function, and quality of life.
详细描述
Knee OA symptoms are known to be impacted by increased joint loading and reduced joint space width between the articulating bones.
Objectives:
- Primary objective: Investigate the short- and long-term efficacy of adding nonsurgical knee joint distraction to standard multimodal physical therapy treatment on pain, joint function and quality of life in patients with knee OA compared with standard physical therapy treatment alone.
- Secondary objective: examine whether the efficacy of mechanical traction would differ based on the mode of application (continuous vs. intermittent traction).
Design and Subjects: A prospective, active control, three-parallel-group, investigator-blinded, randomized controlled trial. 198 subjects will be recruited and randomly assigned to one of three study groups at a 1:1:1 allocation ratio (66 participants per group): a) Standard care only, b) continuous mechanical traction plus standard care, and c) intermittent mechanical traction plus standard care.
Intervention: Participants in the standard care only group will receive 16 treatment sessions (2sessions/week) over 8 weeks, followed by 4 booster sessions (1session/2months) during the one-year period of the trial. Mechanical traction groups will receive standard care in addition to 20-minute knee traction (continuous or intermittent) using an external weight applying knee traction force.
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
- Single (Outcomes Assessor)
盲法说明
Both the outcome assessors and the study statistician will be blinded to group allocation.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥40 years of age;
- •having knee pain;
- •having at least three of the following additional symptoms: a-morning stiffness ≤ 30 minutes, b-crepitation, c-bone margin tenderness, d-bony enlargement or e-no palpable warmth;
- •willing to provide informed consent
排除标准
- •rheumatoid arthritis;
- •serious pathological conditions (inflammatory arthritis and malignancy); total or partial arthroplasty of the affected knee joint, or on waiting list for joint replacement surgery;
- •recent surgical procedure of the lower extremities in the previous 6 months;
- •uncontrolled hypertension and unstable cardiovascular problems that could subject the participant to increased risk with exercise and physical exertion;
- •physical incapability to safely perform exercises, walking or stationary cycling, as in: debilitating visual defects, neurological problems, exaggerated low back pain, advanced osteoporosis, and inability to walk 10 meters without an assistive device;
- •use of prescribed analgesics, corticosteroid or analgesic injection intervention for knee pain within the previous 30 days;
- •lack of clear comprehension of study procedures or inability to comply with instructions;
- •stated inability to attend or complete the proposed course of intervention and follow-up schedule.
结局指标
主要结局
Change in pain score using the Arabic version of the Knee Injury and Osteoarthritis Outcome Score (KOOS)
时间窗: Baseline, 2, 6 and 12 months follow-up
A 5-point Likert scale comprised of 42 questions across 5 subscales. Standardized answers are assigned a score from 0 (no symptoms) to 4 (extreme symptoms). A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Change in physical function score using the Arabic version of the Knee Injury and Osteoarthritis Outcome Score (KOOS)
时间窗: Baseline, 2, 6 and 12 months follow-up
A 5-point Likert scale comprised of 42 questions across 5 subscales. Standardized answers are assigned a score from 0 (no symptoms) to 4 (extreme symptoms). A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
次要结局
- Change in knee pain using the Arabic version of the Numeric Pain Rating Scale (ANPRS)(Baseline, 2, 6 and 12 months follow-up)
- Change in Patient's Global Assessment(2, 6, 12 months follow-up)
- Change in the time taken to complete the Timed Up and Go (TUG)(Baseline, 2, 6 and 12 months follow-up)
- Change in Health-related Quality of Life score using the Arabic version of the Short Form 36 (SF-36) scale(Baseline, 2, 6 and 12 months follow-up)
- change in the Patient's Self-perceived Efficacy of treatment(2, 6 and 12 months follow-up)
- Change in the wakling speed for the 40m fast-paced walk test(Baseline, 2, 6 and 12 months follow-up)
- Change in number of repetitions during the 30s chair stand test(Baseline, 2, 6 and 12 months follow-up)
- Change in other subscales of the Knee Injury and Osteoarthritis Outcome Score (KOOS (Symptoms, Sport and Recreation Function, and knee-related Quality of Life).(Baseline, 2, 6 and 12 months follow-up)
研究者
Ahmed Farrag
Assistant Professor
Prince Sultan Military College of Health Sciences