Effects of Various Types of Ultrasound Therapy in Hip Osteoarthritis - a Double-blinded, Placebo-controlled, Follow-up Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- change in quality of life
研究概览
简要总结
This study evaluates the effects of various types of ultrasound therapy: continuous, pulsed, sham ultrasound and ultrasound combined with electrotherapy in patients with hip osteoarthritis. Beside ultrasound therapy, patients received usual physiotherapy (balneotherapy, exercise and massage) either.
详细描述
During ultrasound therapy electrical energy is converted into mechanical energy and heat. It has physical, chemical and biologic effects, like thermal effect, micro-massage, increased tissue metabolism, capillary permeability and tissue healing. Continuous or pulsed forms can be applied.
As pulsed ultrasound therapy has no thermal effect, greater intensity can be used. It can alleviate acute pain and inflammation. Continuous ultrasound is usually used in chronic musculoskeletal diseases, in case of limitation of joint motion because its thermal effect.
Ultrasound can be combined with electrotherapy, when the effects of the two modalities are summed up.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients over 18 years of age with moderate hip osteoarthritis (radiologically Kellgren- Laurence II-III. stage)
- •chronic hip pain (for at least 8 weeks)
- •pain intensity is ≥ 50mm on a Visual Analogue Scale
- •no physiotherapy or local injection (steroid, hialuronic acid) within 3 months before starting the study
排除标准
- •acute hip pain (duration is less than 8 weeks)
- •steroid, hialuronic acid injection into the hip joint within 3 months
- •physiotherapy of the hip within 3 months
- •inflammatory hip osteoarthritis
- •infection
- •pregnancy
- •untreated hypertension
- •heart failure (NYHA II-IV. stage)
- •inflammatory rheumatic diseases
- •hip arthroplasty
- •pacemaker or intracardiac device
- •severe osteoporosis
- •osteomyelitis
研究组 & 干预措施
Usual physiotherapy and continuous ultrasound therapy
Patients received usual physiotherapy (exercise, massage, balneotherapy) and continuous ultrasound therapy (BTL-4825S Premium device, head size of 5 cm2, 3 MHz frequency, 1,5 W/cm2 SATA intensity) every working day for two weeks (10 occasions).
干预措施: Continuous ultrasound therapy (Device)
Usual physiotherapy and pulsed ultrasound therapy
Patients received usual physiotherapy (exercise, massage, balneotherapy) and pulsed ultrasound therapy (BTL-4825S Premium device, head size of 5 cm2, 3 MHz frequency, 1,5 W/cm2 SATA intensity, 50% duty cycle) every working day for two weeks (10 occasions).
干预措施: pulsed ultrasound therapy (Device)
Usual physiotherapy and sonotens therapy
Patients received usual physiotherapy (exercise, massage, balneotherapy) and sonotens therapy (BTL-4825S Premium device, head size of 5 cm2, 3 MHz frequency, 0,5 W/cm2 SATA intensity, transcutanous electrical nerve stimulation) every working day for two weeks (10 occasions).
干预措施: US and electrotherapy (sonotens) (Device)
Usual physiotherapy and sham ultrasound therapy
Patients received usual physiotherapy (exercise, massage, balneotherapy) and sham ultrasound therapy (BTL-4825S Premium device, head size of 5 cm2, 0 MHz frequency, 0 W/cm2 SATA intensity) every working day for two weeks (10 occasions).
干预措施: Sham ultrasound therapy (Device)
结局指标
主要结局
change in quality of life
时间窗: Week 0 and Week 12
change from baseline quality of life (36-Item Short Form Health Survey /SF-36/) at week 12. It consists of eight scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more the disability, i.e. a score of zero is equivalent to maximum disability.
change in severity of pain at rest
时间窗: Week 0 and Week 12
change from baseline severity of pain at rest recorded on a 100 mm visual analogue scale, where 0 mm represents no pain, 100 mm represents unbearable pain.
change in function
时间窗: Week 0 and Week 12
change from baseline Western Ontario and McMaster Universities Arthritis Index (WOMAC) at week 12. It is comprised of 24 items divided into three subscales: Pain (5 items), stiffness (2 items), and physical function (17 items). All the items are scored on a 100mm visual analogue scale. Values are summed up for a combined WOMAC score. The lower score represents better outcome.
次要结局
未报告次要终点
研究者
Márta Király
chief physician
Petz Aladar County Teaching Hospital