Efficacy of Acupuncture in Treating Comorbid Chronic Nonspecific Neck Pain and Insomnia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 124
- Primary Endpoint
- The change from baseline in the Chinese version of the Insomnia Severity Index (ISI-C) scores.
Study Overview
Brief Summary
The study aims to assess the efficacy and safety of acupuncture among patients with chronic nonspecific neck pain and insomnia, compared with sham acupuncture.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
acupuncture group
Participants in the acupuncture group will receive treatment at DU 20 [Baihui], EX-HN15 [Jingbailao], GB 12 [Wangu], Shangyintang (On the head, 1 B-cun superior to Yintang), HT7 [Shenmen], KI 3 [Taixi] and Ashi Point.
The treatment will last 30 minutes for each session, 3 sessions per week (ideally every other day) for a succession of 4 weeks.
Intervention: Acupuncture (Device)
Sham acupuncture (SA) group
Participants in the SA group will receive treatment at sham DU 20, sham EX-sham HN15, sham GB 12, sham Shangyintang , sham HT7 and sham KI 3. The treatment will last 30 minutes for each session, 3 sessions per week (ideally every other day) for a succession of 4 weeks.
Intervention: sham acupuncture (Device)
Outcomes
Primary Outcomes
The change from baseline in the Chinese version of the Insomnia Severity Index (ISI-C) scores.
Time Frame: 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 in average 24h overall neck pain intensity measured by NRS from baseline over the past week
Time Frame: 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.
Time Frame: 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)."
Secondary Outcomes
- 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.)
- 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.)
Investigators
Liu Zhishun
professer
Guang'anmen Hospital of China Academy of Chinese Medical Sciences