Efficacy of Acupuncture in Treating Comorbid Chronic Nonspecific Neck Pain and Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 124
- 主要终点
- The change in average 24h overall neck pain intensity measured by NRS from baseline over the past week
研究概览
简要总结
The study aims to assess the efficacy and safety of acupuncture among patients with chronic nonspecific neck pain and insomnia, compared with sham acupuncture.
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)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 75 years old;
- •Meet the diagnostic criteria for both chronic nonspecific neck pain and chronic insomnia;
- •The patient's average 24-hour overall neck pain intensity score on the NRS is ≥3;
- •The patient's Insomnia Severity Index (ISI) score is ≥10;
- •The patient is willing to participate in the study and has signed the informed consent form.
排除标准
- •Specific neck pain with a clear etiology, including trauma, tumor, connective tissue disease, rheumatic disease, metabolic and endocrine disorders, neuropathy, spinal cord disease, fracture, or vertebral misalignment;
- •Positive Spurling test, neck flexion test, upper limb traction test, or foraminal distraction test. Neck pain accompanied by radiating pain in the upper limbs or radicular compression symptoms, or acute exacerbation of neck pain;
- •Neck pain accompanied by sensory disturbances or other neurological symptoms, or ankylosis of the facet joints;
- •Previous history of cervical spine surgery;
- •Previous history of head and neck trauma, such as whiplash injury;
- •Insomnia caused by medications (e.g., caffeine, corticosteroids), withdrawal reactions, or other underlying conditions (e.g., hyperthyroidism, severe anxiety/depressive disorders);
- •Long-term use of analgesics, muscle relaxants, or hormones, or presence of other pain more severe than neck pain;
- •Other sleep disorders, such as sleep apnea syndrome, or shift workers;
- •Presence of psychiatric disorders (e.g., depression), cognitive impairment, or language disorders;
- •Patients with drug dependency;
- •Received acupuncture treatment within the past month;
- •Severe cardiovascular, hepatic, renal, hematologic, autoimmune diseases, infectious diseases, poor general nutritional status, malignancy, or patients in the terminal stage of severe illness;
- •Pregnant or planning to become pregnant within the next year, breastfeeding, or postpartum ≤12 months.
结局指标
主要结局
The change in average 24h overall neck pain intensity measured by NRS from baseline over the past week
时间窗: week 5
The NRS score ranges from 0 to 10, with higher scores indicating more severe pain.
The change from baseline in the Chinese version of the Insomnia Severity Index (ISI-C) scores.
时间窗: week 5
The Chinese version of the Insomnia Severity Index (ISI-C) will be used to assess the severity of patients' self-perceived insomnia symptoms. Each item is rated on a scale from 0 to 4, with a total score ranging from 0 to 28. Based on the total score, the severity of insomnia can be categorized into four levels: a score of 0-7 indicates "no clinically significant insomnia," 8-14 indicates "subclinical insomnia," 15-21 indicates "clinical insomnia (moderate)," and 22-28 indicates "clinical insomnia (severe)."
The change from baseline in the Chinese version of the Insomnia Severity Index (ISI-C) scores.
时间窗: week 5
The Chinese version of the Insomnia Severity Index (ISI-C) will be used to assess the severity of patients' self-perceived insomnia symptoms. Each item is rated on a scale from 0 to 4, with a total score ranging from 0 to 28. Based on the total score, the severity of insomnia can be categorized into four levels: a score of 0-7 indicates "no clinically significant insomnia," 8-14 indicates "subclinical insomnia," 15-21 indicates "clinical insomnia (moderate)," and 22-28 indicates "clinical insomnia (severe)."
次要结局
- The change from baseline in the total score of the Neck Disability Index (NDI).(week 5, 9 and 16)
- The change in average 24h overall neck pain intensity measured by NRS from baseline over the past week(week 9 and 16)
- The change from baseline in the maximum pain intensity score on the NRS during six directions of neck movement.(week 5, 9 and 16)
- The change from baseline in the ISI-C scores.(week 9 and 16)
- The change from baseline in the Pittsburgh Sleep Quality Index (PSQI).(week 5, 9 and 16)
- The proportion of participants with at least 30% reduction in NRS scores from baseline(week 5, 9 and 16)
- The proportion of participants with at least 6 points reduction in ISI-C scores from baseline(week 5, 9 and 16)
- The proportion of participants with at least 10 points reduction in NDI scores from baseline(week 5, 9 and 16)
- The total number of days of using rescue analgesics and sedative-hypnotics.(week 5, 9 and 16)
- The change from baseline in the Hospital Anxiety and Depression Scale (HADS) scores.(week 5, 9 and 16)
- The proportion of responders per the Patient Global Impression of Change (PGI-C)(week 5 and 16)
- The percentage of patients who used rescue analgesics and sedative-hypnotics.(week 5, 9 and 16)
- Blinding assessment(Within 5 minutes after the last treatment at week 4.)
- The change from baseline in the Hospital Anxiety and Depression Scale (HADS) scores.(week 5, 9 and 16)
- The change from baseline in the ISI-C scores.(week 9 and 16)
- The proportion of participants with at least 30% reduction in NRS scores from baseline(week 5, 9 and 16)
- The proportion of participants with at least 6 points reduction in ISI-C scores from baseline(week 5, 9 and 16)
- The change from baseline in the total score of the Neck Disability Index (NDI).(week 5, 9 and 16)
- The proportion of participants with at least 10 points reduction in NDI scores from baseline(week 5, 9 and 16)
- The change from baseline in the maximum pain intensity score on the NRS during six directions of neck movement.(week 5, 9 and 16)
- The change from baseline in the Pittsburgh Sleep Quality Index (PSQI).(week 5, 9 and 16)
- The total number of days of using rescue analgesics and sedative-hypnotics.(week 5, 9 and 16)
- Blinding assessment(Within 5 minutes after the last treatment at week 4.)
研究者
Liu Zhishun
professer
Guang'anmen Hospital of China Academy of Chinese Medical Sciences