A Randomized Controlled Trial on the Effect of Focal Thermal Therapy at Acupuncture Points in the Treatment of Osteoarthritis of the Knee
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 主要终点
- Short Form-12 version 2 (SF-12v2)
研究概览
简要总结
Osteoarthritis of the knee is a common degenerative joint disorder in our ageing population. A combination of thermal therapy with a self-management exercise have shown a positive effect in the management of osteoarthritis of the knee. This study aimed to compare the effectiveness of topical heat pack versus focal application of heat therapy at the acupressure points in the treatment of osteoarthritis of the knee.
详细描述
Osteoarthritis of the knee is a common degenerative joint disorder in our ageing population. A combination of thermal therapy with a self-management exercise have shown a positive effect in the management of osteoarthritis of the knee. This study aimed to compare the effectiveness of topical heat pack versus focal application of heat therapy at the acupressure points in the treatment of osteoarthritis of the knee.
A randomized control trial was conducted in 76 patients with osteoarthritis of the knee, diagnosed by an experienced orthopedic surgeon. Following inclusion and exclusion selection, patients were randomly allocated to group 1 (Heat Pack) or group 2 (Thermal Gun). All patients received 30 minutes of treatment in each session, twice a week for 4 weeks. They also received an education program and taught home knee exercises. Outcome measurements were Visual Analog Scale (VAS) for pain intensity, muscle power, knee ROM, WOMAC and SF-12v2.
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, Care Provider)
盲法说明
Envelope
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
- •male or female patients aged 40 years old or older
- •clinical and radiological diagnosis of osteoarthritis of the knee based on the OA Knee clinical guidelines and radiological evidence
- •normal skin sensation to heat, cold, pins and pricks (i.e. passed the required Skin Sensation Test)
- •not participating in any other clinical trial at time of this study
- •be able to complete the whole trial period
- •no cognitive dysfunction and was able to sign the consent form
排除标准
- •received bilateral knee arthroplasty before this study
- •polyarthritis affecting more than both knee
- •active skin lesion
- •women in pregnancy or breasts feeding
- •received acupuncture and/or moxibustion within one month of the study
- •unable to comply with the study protocol
结局指标
主要结局
Short Form-12 version 2 (SF-12v2)
时间窗: After 1 year
Quality of life evaluation; Expressed by Physical component summary (PCS) and Mental component summary (MCS); Both numeric, The higher score the better outcome
Quadriceps and hamstrings muscle strength
时间窗: After 1 year
Quadriceps and hamstrings muscle strength were measured according to the Oxford Scale of Muscle Strength; Numeric
Western Ontario and McMasters Universities (WOMAC)
时间窗: After 1 year
Functional assessment with the validated Chinese version of the Western Ontario and McMasters Universities (WOMAC); Numeric
Visual analogue scale (VAS) for pain
时间窗: After 1 year
10-scale likert scale to measure pain level visually; Minimum = 0 and Maximum value = 10, and higher scores mean a better outcome.
Knee range of movement (ROM)
时间窗: After 1 year
Knee range of movement (ROM) in the supine position using a goniometer; Numeric
次要结局
未报告次要终点
研究者
Dr. Ho Ki Wai
Clinical Professional Consultant
Chinese University of Hong Kong