ACUPUNCTURE FOR THE POSTOPERATIVE RECOVERY OF HIP FRACTURE PATIENTS: A PILOT RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- 1. Modified Harris Hip Score
研究概览
简要总结
Hip surgery is a common and safe medical intervention to restore the functionality and mobility of the hip joint in patients suffering from hip fractures. Despite the advances in surgical techniques, a relatively large proportion of patients suffer from postoperative pain, joint dysfunction and loss of muscle strength. These outcomes hinder rehabilitation, which consequently imposes significant economic burden for health systems.
This study aims to assess if the addition of acupuncture to existing postoperative management will improve the following patient outcomes post hip surgery:
- Postoperative pain
- Function (muscular strength and mobility)
Methods Patients who underwent hip surgery due to unilateral hip fracture, who fulfill the inclusion and exclusion criteria, will be randomly allocated to either receive postoperative management ONLY (Conventional analgesics and physiotherapy) or with the addition of acupuncture post hip surgery.
In additional to standard care, acupuncture will be performed on patients in Group A twice a week from post-operative week (POW) 5 to 8, a total of 8 acupuncture treatments will be administered. From the 2nd to 8th treatment, electroacupuncture and infrared therapeutic lamp will be used. Group B will receive only standard post-operative management.
For patients in both Group A and B, primary outcomes will be assessed at the following time points: Post- Operative Week (POW) 0, 6, Post-Operative Month (POM) 6 and 12, while the secondary outcomes will be assessed at the following time points: POW 6, POM 6 and 12. The Primary Outcomes include:1. Modified Harris Hip Score 2. Visual Analogue Scale (VAS-100). The Secondary Outcomes include: 1. Timed Up and Go (TUG) assessment. The TUG assessment will be performed thrice during each assessment and an average time will be taken. 2. Lower extremity muscle strength measured using a portable dynamometer. The subject's operated and non-operated side will be measured.
Hypothesis The addition of acupuncture to existing postoperative management will reduce pain and enhance functional recovery, better and faster than with postoperative management alone.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Randomization/Allocation Concealment: 1) KTPH CRU Biostatistician (non-study team member) will use a random number generator to create a random sequence for the subjects. There will be a corresponding subject number in running sequence to each randomized generated number. The randomized numbers will then be categorized into 2 groups, odd numbers into either acupuncture or control group then even numbers into the other. 2) 90 opaque sealed envelopes will be prepared for 90 subjects. The subject number will be written on the front of each envelope. Inside each envelope, there is an insert stating the group which the subject is allocated to. 3) These sealed envelopes will be handed over to the study team. The study team member will take the relevant envelope in accordance with the subject number to check what group the subject is allocated to.
入排标准
- 年龄范围
- 40 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who undergone surgery due to unilateral hip fracture. Patients aged 40-99 (male), 55-99 (female). Ambulatory with or without aid prior to hip fracture. Able provide consent for the study and acupuncture treatment. Able to attend all treatment sessions
排除标准
- •Patients with morbid obesity (Body Mass Index >40) . Patients with communication barriers such as aphasia or language . Local or systemic infection or dermatological disease affecting sites of acupuncture. Existing treatment with anti-neoplastic, oral corticoid or immunosuppressive drugs. Needle phobia or inability to stay still for 30 min during acupuncture retention . History of psychiatric disease, kidney failure on peritoneal dialysis, substance abuse . If there exist any postoperative complications that deviate from standard management, resulting in interference of patient's clinical evaluation
结局指标
主要结局
1. Modified Harris Hip Score
时间窗: postoperative Week (POW) 0, 6, postoperative month (POM) 6 and POM 12
Assessing pain and function
Visual Analogue Scale (VAS)-100
时间窗: postoperative Week (POW) 0, 6, postoperative month (POM) 6 and POM 12
For assessing the pain intensity
次要结局
- Timed get Up and Go (TUG) test(POW 6, POM 6 and 12)
- Lower extremity muscle strength(POW 6, POM 6 and 12)
研究者
Ong Zhi Lin Melissa
Dr Antony Xavier Rex Premchand, Senior Consultant; Specialties/Sub-Specialties Orthopaedic Surgery
Khoo Teck Puat Hospital