Effect of Acupuncture on Chronic Nonspecific Neck Pain and Insomnia

Not Applicable

Not yet recruiting

• Conditions: Neck Pain Chronic; Insomnia Chronic

• Registration Number: NCT06996210
• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-14
• Study First Submitted QC: 2025-05-28
• Last Update Submitted: 2025-05-28
• Study First Posted: 2025-05-30
• Last Update Posted: 2025-05-30
• Study Start: 2025-07-01
• Primary Completion: 2027-12-27
• Study Completion: 2028-03-27

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

1. Aged 18 to 75 years old;
2. Meet the diagnostic criteria for both chronic nonspecific neck pain and chronic insomnia;
3. The patient's average neck pain intensity score on the Numeric Rating Scale (NRS) over the past 3 days is ≥3;
4. The patient's Insomnia Severity Index (ISI) score is ≥10;
5. The patient is willing to participate in the study and has signed the informed consent form.

Exclusion Criteria

1. 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;
2. 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;
3. Neck pain accompanied by sensory disturbances or other neurological symptoms, or ankylosis of the facet joints;
4. Previous history of cervical spine surgery;
5. Previous history of head and neck trauma, such as whiplash injury;
6. Insomnia caused by medications (e.g., caffeine, corticosteroids), withdrawal reactions, or other underlying conditions (e.g., hyperthyroidism, severe anxiety/depressive disorders);
7. Long-term use of analgesics, muscle relaxants, or hormones, or presence of other pain more severe than neck pain;
8. Other sleep disorders, such as sleep apnea syndrome, or shift workers;
9. Presence of psychiatric disorders (e.g., depression), cognitive impairment, or language disorders;
10. Patients with drug dependency;
11. Received acupuncture treatment within the past month;
12. Severe cardiovascular, hepatic, renal, hematologic, autoimmune diseases, infectious diseases, poor general nutritional status, malignancy, or patients in the terminal stage of severe illness;
13. Pregnant or planning to become pregnant within the next year, breastfeeding, or postpartum ≤12 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The change from baseline in the overall neck pain intensity score on the Numeric Rating Scale (NRS) ranging from 0-10 over the last 3 days. 0 refers to no pain and 10 refers to the worst pain imaginable. The highest NRS score on the worst pain.	week 5	Patients will be asked to choose any 3 days in the past week and assess the neck pain over the past 24 hours. They will select a number from the Numerical Rating Scale (NRS) that represents the intensity of their pain. The average value of the overall NRS neck pain scores for these 3 days over the past 24 hours was calculated.
The change from baseline in the Chinese version of the Insomnia Severity Index (ISI-C) scores.	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 over the past two weeks. 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 Outcome Measures

Name	Time	Method
Blinding assessment	Within 5 minutes after the last treatment at week 4.	Participants will be asked the question: Do you think you have received traditional electroacupuncture in the past 4 weeks?
The total number of days of using rescue analgesics and sedative-hypnotics.	week 5, 9 and 16	The total number of days of using rescue analgesics and sedative-hypnotics in the past past week.
The change from baseline in the overall neck pain intensity score on the NRS over the last 3 days.	week 9 and 16	The change from baseline in the overall neck pain intensity score on the NRS ranging from 0-10 over the last 3 days. 0 refers to no pain and 10 refers to the worst pain imaginable. The highest NRS score on the worst pain.
The change from baseline in the ISI-C scores.	week 9 and 16	The ISI-C will be used to assess the severity of patients' self-perceived insomnia symptoms over the past two weeks. 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 proportion of participants with at least 30% reduction in NRS scores from baseline	week 5, 9 and 16	The change from baseline in the overall neck pain intensity score on the NRS ranging from 0-10 over the last 3 days. 0 refers to no pain and 10 refers to the worst pain imaginable. The highest NRS score on the worst pain.
The proportion of participants with at least 6 points reduction in ISI-C scores from baseline	week 5, 9 and 16	The ISI-C will be used to assess the severity of patients' self-perceived insomnia symptoms over the past two weeks. 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 total score of the Neck Disability Index (NDI).	week 5, 9 and 16	Neck Disability Index (NDI) consists of 10 items, with a total score ranging from 0 to 50. A higher score indicates a greater impact of neck pain on quality of life.
The proportion of participants with at least 10 points reduction in NDI scores from baseline	week 5, 9 and 16	NDI consists of 10 items, with a total score ranging from 0 to 50. A higher score indicates a greater impact of neck pain on quality of life.
The change from baseline in the maximum pain intensity score on the NRS during six directions of neck movement.	week 5, 9 and 16	Evaluate on any one day of the week by recording the maximum pain intensity score on the NRS during the six movements of maximum voluntary neck flexion, extension, lateral flexion, and left/right rotation. Conduct this evaluation once and take the highest NRS score for neck pain. NRS score ranges from 0-10. 0 refers to no pain and 10 refers to the worst pain imaginable. The highest NRS score on the worst breast pain during the cycle is defined as the final score on the worst pain.
The change from baseline in the Pittsburgh Sleep Quality Index (PSQI).	week 5, 9 and 16	The PSQI has a total score ranging from 0 to 21. A higher score indicates poorer sleep quality. Specifically, a total score of 0-5 indicates very good sleep quality; 6-10 indicates fairly good sleep quality; 11-15 indicates average sleep quality; and 16-21 indicates poor sleep quality.
The change from baseline in the Hospital Anxiety and Depression Scale (HADS) scores.	week 5, 9 and 16	The HADS score ranges from 0 to 42, with higher scores indicating greater anxiety and depression.
The proportion of responders per the Patient Global Index of Improvement (PGI-I)	week 5and 16	The PGI-I evaluates the overall treatment effect perceived by patients themselves. The change can be rated in 7 levels, including "very much better", "much better", "a little better", "no change", "a little worse", "much worse" or "very much worse".
The percentage of patients who used rescue analgesics and sedative-hypnotics in the past week.	week 5, 9 and 16	The percentage of patients who used emergency analgesics and sedative-hypnotics in the past week.