The Experiences for Receiving Auriculotherapy for Osteoarthritis Knee: A Randomised Controlled Feasibility Study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 4
- 主要终点
- Numerical rating scale of pain (NRS) :
研究概览
简要总结
Osteoarthritis (OA) is the most common form of arthritis in Hong Kong and a prevalent condition in the ageing population. With disease progression, some clients may develop severe pain and profound limitations in ambulation, which may result in morbidity and impaired physical functions. Among the available treatments, pharmacological therapies primarily focus on musculoskeletal pain relief. However, adverse effects, such as gastrointestinal haemorrhage arising from non-steroidal anti-inflammatory drugs have led to an increasing number of concerns regarding the use of these treatments. Other non-invasive complementary methods for osteoarthritic knee (OA knee) should be explored because of the limitations of pharmacological therapy.
Auriculotherapy (AT) is one of the approaches in traditional Chinese medicine (TCM). It is a therapeutic method by which specific points on the auricle are stimulated to treat various disorders of the body. The present study is a four-arm randomised controlled study to determine the effectiveness of AT using magneto-AT (MAT) and/or laser AT (LAT) to improve the conditions of elderly patients suffering from OA knee. The effectiveness of MAT and LAT in terms of alleviating pain, relieving stiffness and promoting a range of motion, and enhancing functional abilities will be determined.
Subjects in 'Treatment arm 1' will receive MAT on specific auricular points on one side of the ear during each treatment session. A deactivated laser will be used to achieve the effect of subject blinding. Subjects in 'Treatment arm 2' will receive LAT using low-energy laser applied to selected acupoints of the ear, and a plaster centred with a portion of Junci Medulla that mimics MAT treatment will also be given. Subjects in 'Treatment arm 3' will receive a combined approach (both MAT and LAT). Subjects in the 'placebo arm' will serve as placebo controls. Six auricular acupoints that are considered to have an effect on the OA knee will be selected. Only one ear at a time will receive treatment. Thus, the ears will be treated alternately. The total treatment period will be four weeks. The experimental objects will be replaced every other day. Therefore, treatment will be performed thrice a week. Subjects will be assessed at baseline up to 3 months after the therapy. This study could advance the knowledge on the complementary approaches than can be used to improve OA knee conditions in the elderly.
详细描述
Objectives of study
- To assess the feasibility of AT among elders with OA knee in a future large-scale study, including the use of blinding (subjects and evaluator), acceptance of treatment protocol, follow-up for repetitive testing, estimating effect size and attrition rate.
- To evaluate the preliminary effect of MAT, LAT or a combined approach among elders with OA knee.
- To elicit subjects' experiences towards the use of AT in this clinical trial.
Design: This study is a double-blinded randomised controlled trial with a 2 x 2 factorial design, nested with a qualitative study to elicit the experiences of subjects towards the use of AT for OA knee.
Stage I: RCT with factorial design Experimental and control interventions Eligible subjects will be randomly and blindly allocated to one of the four groups, to be decided by a computer-generated randomised table. Restricted randomisation by blocking will be used to ensure approximately similar sample sizes for each group at any time during the trial according to equal proportion rule (1:1:1:1). The random allocation sequence will be managed by a specified research assistant (RA) who is not involved in this trial and is concealed to the assessors.
Treatment arm 1 (MAT & placebo LAT): Subjects will receive MAT. The magnetic pellets will contain an average of ~200 gauss/pellet magnetic flux densities, with a diameter of 1.76 mm. The experimental object will be applied to the reactive region of each of the six selected acupoints as detected by an acupoint detector. The justifications for selecting these acupoints are described below. To achieve a blinding and placebo effect of the subject, the laser device will be switched to "power off" mode (i.e. deactivated laser) for acupoint "stimulation" prior to the application of MAT. Subjects will be asked to wear a pair of laser protective goggles to "blind" them during therapy administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The OA condition will be assessed by physical examination based on the clinical criteria of the American College of Rheumatology criteria. The clinical criteria consisted of pain in the knee and any three of the following:
- •aged 50 years of age or over;
- •<=30 minutes of morning stiffness;
- •crepitus on active joint motion;
- •bony tenderness;
- •bony enlargement; or
- •no palpable joint warmth.
- •This classification has been reported to yield 84% specificity and 89% sensitivity for diagnosis of OA knee.
排除标准
- •other connective tissue diseases affecting the knee;
- •knee joint steroid injections within the preceding three months;
- •having a hearing aid or pacemaker in situ (this is to avoid possible interaction between the pacemaker and the magnetic pellets);
- •receiving AT within the preceding three months;
- •suffering from aural injuries or infections; and
- •inability to understand instructions or give consent.
- •The assessment is conducted by a research assistant who will receive intensive coaching on the physical assessment and therapy administration by the research team. Potential subjects will be further assessed by a registered medical practitioner who has over 15 years of clinical experience when the assessment on the OA condition by the RA and the research team is in doubt.
结局指标
主要结局
Numerical rating scale of pain (NRS) :
时间窗: collected at baseline up to 3 months after therapy
According to the OMERACT III conference, which was conducted to establish a core set of outcome measures for future OA trials, the perception of pain has the highest preference among the core set of efficacy domains. Therefore, pain perception using NRS is adopted in this study as a primary outcome. The use of NRS is also considered as a good first choice to evaluate pain perception for most older adults because of its established psychometric properties, increased ability to discriminate pain levels, and common use in clinical practice. The NRS could be administered in written or verbal form, and it involves asking the subject to select a number, from 1 to 10 to the nearest 0.5 interval, to represent their maximal OA induced knee pain in the recent 2 to 3 days.
次要结局
- Standard goniometer(collected at baseline up to 3 months after therapy)
- Subjects' expectations towards therapy(collected at baseline up to 3 months after therapy)
- (2) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(collected at baseline up to 3 months after therapy)
- Timed-up-and-go test (TUGT)(collected at baseline up to 3 months after therapy)
研究者
Lorna Suen
Associate Professor
The Hong Kong Polytechnic University