Efficacy and Safety of Acupuncture in the Treatment of Osteoarthritis of the Knee: Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Numerical rating scale
研究概览
简要总结
The main question of this study was to evaluate the efficacy and safety of acupuncture in the treatment of knee osteoarthritis (KOA) through a single-blind, randomized controlled trial divided into two groups. Patients in both groups received a total of 24 acupuncture treatments over an 8-week period. The differences in knee NRS score, WOMAC index, walking test, mental health assessment and other indicators between the acupuncture group and the sham acupuncture group before and after treatment were compared to provide high-quality evidence to support the effectiveness of acupuncture in treating KOA.
详细描述
Knee osteoarthritis (KOA) is a common clinical bone and joint disease.There is a lack of effective specific treatment for KOA.Acupuncture is increasingly being studied for the treatment of KOA, but its efficacy and safety are still controversial.This study aims to provide high-quality evidence by evaluating the results of studies on acupuncture for KOA.
A single-blind, randomized controlled trial design was used in this study, in which the generation and preservation of the randomized sequence was done by an independent follow-up researcher through R software. The random allocation method used was block group randomization to ensure a balanced allocation. At the same time, opaque sealed envelopes containing grouping information were prepared to ensure that the grouping process was concealed. The principle of blinding was strictly implemented throughout the study, and the outcome evaluator was blinded until the end of the trial, when participants remained unknown about their grouping information. The study population consisted of 350 patients with KOA who met the inclusion and exclusion criteria. These patients were randomized in a 1:1 ratio into the following 2 groups:(1) Acupuncture Group (AG) (2) False Acupuncture Group (FAG).Patients in both groups received a total of 24 acupuncture treatments over an 8-week period. The sham acupuncture group utilized a Takakura acupuncture simulation device to mimic acupuncture, where the needles would not penetrate the skin, and the duration of needle retention, treatment points, frequency of treatments, duration of treatment, and follow-up period were kept the same as that of the real acupuncture group. The primary outcome index was the Numerical rating scale (NRS), and secondary outcomes included the Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC),40m Fast-Paced Walking Test(40m FPWT), Roland-Morris Disability Questionnaire (RMDQ), Hamilton Depression Rating Scale (HAMD-17), Hamilton Anxiety Rating Scale (HAMA), Insomnia Severity Index (ISI), Pain self-efficacy questionnaire (PSEQ). Any adverse events during treatment will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Outpatient physicians (X.T and X.Z.X) will perform the initial assessment of the patient, independently enter and collect patient information, and randomize assignment. Patients, outcome assessors and data analysts are not aware of the assignment. The treating physician (W.Z.N) will treat the grouped patients. The statistical analysis team will blind the subgroup assignment and the study. Unblinding will take place at the completion of the trial or at the occurrence of a serious adverse event.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18-70 years old, regardless of gender
- •meeting the diagnostic criteria of the American College of Rheumatology (ACR) of KOA
- •patients with an NRS score of at least greater than 4 for knee pain, and the pain has lasted for at least 3 months
- •diagnosed with osteoarthritis of the knee by magnetic resonance imaging (MRI) or x-ray in the last 3 years
- •volunteering to participate in this trial and signing informed consent
排除标准
- •Patients with a history of knee surgery
- •Patients who had received any physical therapy related to osteoarthritis of the knee, such as corticosteroid injections, acupuncture, or moxibustion, within the past 3 months
- •Patients who had a disease that could lead to pain in the knee, such as a fracture, a synovial cyst, or rheumatoid arthritis
- •Patients who had a history of knee surgery. or any significant neurological injury
- •Prior serious mental illness, organ failure, or malignancy
- •Planned knee surgery within the next 3 months
- •Pregnancy or breastfeeding
结局指标
主要结局
Numerical rating scale
时间窗: For participants who completed baseline enrollment, efficacy observations were made at treatment enrollment, week 4, week 8, week 16, and week 24.
The NRS is a commonly used pain assessment tool〔42〕, especially for joint pain, such as knee pain. The scale consists of 11 numbers, ranging from 0 to 10, each representing a different level of pain, and the patient chooses the number that best represents his or her current level of pain according to his or her own pain perception.The NRS score is accurate and concise, and was once regarded as the gold standard for pain assessment by the American Pain Society.
次要结局
- WOMAC index(For participants who completed baseline enrollment, efficacy observations were made at treatment enrollment, week 4, week 8, week 16, and week 24.)
- 40m FPWT(For participants who completed baseline enrollment, efficacy observations were made at treatment enrollment, week 4, week 8, week 16, and week 24.)
- RMDQ(For participants who completed baseline enrollment, efficacy observations were made at treatment enrollment, week 4, week 8, week 16, and week 24.)
- Depressive condition(For participants who completed baseline enrollment, efficacy observations were made at treatment enrollment, week 4, week 8, week 16, and week 24.)
- Anxious situation(For participants who completed baseline enrollment, efficacy observations were made at treatment enrollment, week 4, week 8, week 16, and week 24.)
- Insomnia Severity Index(For participants who completed baseline enrollment, efficacy observations were made at treatment enrollment, week 4, week 8, week 16, and week 24.)
- Pain self-efficacy questionnaire(For participants who completed baseline enrollment, efficacy observations were made at treatment enrollment, week 4, week 8, week 16, and week 24.)
研究者
Wu zenan
Principal Investigator
Jiangxi University of Traditional Chinese Medicine