Clinical Effects of Translatoric Grades of Movement in Hip Osteoarthritis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain on the pain subscale of WOMAC index (WOMAC-P)
研究概览
简要总结
In orthopaedic manual therapy translatoric grades of movement are used to determine the intensity of force applied during the mobilization. Different clinical effects are described for each translatoric grade of movement but there are not published studies evaluating these clinical effects.
The objective of this trial is to determine if force magnitude during hip traction in resting position affects immediate and short-term outcomes (pain, physical function, hip muscle length and hip range of motion) in patients with hip osteoarthritis. For this purpose, investigators conduct a randomized clinical trial, double-blind (patient and physical therapist examiner). Participants entering the study were randomized into 1 of 3 treatment groups: grade I- grade IISZ mobilization, grade IITZ mobilization or grade III mobilization. Participants attend three sessions on alternate days (monday, wednesday, friday) and at the same hour. Measurements are taken prior to treatment, immediately after each session treatment.
The participants are recruited from physiotherapy groups or referred by general practitioners and orthopedic surgeons.
Participants were assigned to 1 of the 3 study groups through concealed allocation (sealed envelopes) and independent blocked randomization, using a random number generator.
One physical therapist enroll patients in the study, while an independent research assistant performed the randomization and prepared the sealed envelopes, which are opened after baseline data collection by the physiotherapist performing the treatments. Participants are treated in a private treatment area and have no knowledge of treatments received by other participants.
A second experienced orthopaedic manual therapist applies the standardized hip traction mobilization in resting position at either level of force, during 10 minutes. This amount of mobilization is consistent with clinical practice and previous studies in osteoarthritis patients.
Two physiotherapists (third and fourth) with 5 years of experience, who were blinded to participant group, performed all measurements.The outcome measures are pain, physical function, hip muscle length and hip passive range of motion. Pain is registered with visual analogic scale (VAS), Pressure Pain Threshold ( PPT) and WOMAC pain subscale. Physical function is registered using Timed Up & Go test (TUG), the 20-Meter Walking Test (20MWT) and the physical function subscale of WOMAC index. The hip muscle length is measured using Ely´s test, Active Knee Extension test and modified Ober´s test. The passive hip range of motion is measured using inclinometer or goniometer.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •unilateral primary hip OA according to the clinical criteria of the American College of Reumathology,
- •a grade III Kellgren & Lawrence (K-L) classification in their most recent hip X-rays,
- •mild to moderate pain from hip OA categorized using the WOMAC pain subscale (2 to 8 as mild pain; greater than 8 to 12 as moderate pain),
- •the ability to walk at least 20 meters, with or without an aid.
排除标准
- •neurological, vascular or other lower extremity musculoskeletal conditions that affected sensation, gait or functional performance,
- •contraindications for manual therapy
- •insufficient understanding of the Spanish language
研究组 & 干预措施
Grade I-II SZ mobilization
Grade I-IISZ hip traction in resting position
干预措施: Grade I-II SZ mobilization (Other)
Grade II TZ mobilization
Grade IITZ hip traction in resting position
干预措施: Grade II TZ mobilization (Other)
Grade III mobilization
Grade III hip traction in resting position
干预措施: Grade III mobilization (Other)
结局指标
主要结局
Pain on the pain subscale of WOMAC index (WOMAC-P)
时间窗: pre-intervention and the next day of the last treatment session (baseline and 6 days)
Pain on the VAS scale
时间窗: pre-intervention and post-intervention (baseline and 5 days)
Pressure Pain Threshold (PPT)
时间窗: pre-intervention and post-intervention (baseline and 5 days)
次要结局
- Physical Function on The physical function subscale of WOMAC index (WOMAC-PF)(pre-intervention and the next day of the last treatment session (baseline and 6 days))
- Hamstring flexibility assessment: Active Knee test(pre-intervention and post-intervention after each session (baseline and 5 days))
- Physical Function on Timed Up & Go test (TUG)(pre-intervention and post-intervention (baseline and 5 days))
- Iliotibial band tightness assessment: modified Ober´s test(pre-intervention and post-intervention (baseline and 5 days))
- Physical Function on the 20-Meter Walking Test(pre-intervention and post-intervention (baseline and 5 days))
- Hip range of motion with digital inclinometer(pre-intervention and post-intervention (baseline and 5 days))
- Rectus femoris flexibility assessment: Ely´s test(pre-intervention and post-intervention (baseline and 5 days))
研究者
Elena Estebanez de Miguel
Unidad de investigación en Fisioterapia
Universidad de Zaragoza