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Effect of Acupuncture on Chronic Nonspecific Neck Pain and Insomnia 124

Not yet recruiting
Clinical Trial NCT06996210 is an interventional study for Neck Pain Chronic, Insomnia Chronic and is currently not yet recruiting. Enrollment is planned to begin on 1 September 2025 and continue until the study accrues 124 participants. Led by Guang'anmen Hospital of China Academy of Chinese Medical Sciences, this study is expected to complete by 27 March 2028. The latest data from ClinicalTrials.gov was last updated on 15 July 2025.
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.
Official Title

Efficacy of Acupuncture in Treating Comorbid Chronic Nonspecific Neck Pain and Insomnia

Conditions
Neck Pain ChronicInsomnia Chronic
Other Study IDs
  • 2025-090-KY
NCT ID Number
NCT06996210
Start Date (Actual)
2025-09-01
Last Update Posted
2025-07-15
Completion Date (Estimated)
2028-03-27
Enrollment (Estimated)
124
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Triple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Experimentalacupuncture 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.
Acupuncture
The needles will be inserted to 12.5-30 mm in acupoints through adhesive pads. Needles will be lifted, thrusted and twirled gently for 3 times to achieve deqi sensation and manipulated every ten minutes.
Sham ComparatorSham 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.
sham acupuncture
The needle will be inserted to 2-3mm in sham Baihui acupoint. For the remaining sham acupoints, needles will be inserted into the pad and reaching the skin. Needles will be lifted, thrusted and twirled gently for 3 times to simulate the effect of the needle tip penetrating the skin.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
The change in average 24h overall neck pain intensity measured by NRS from baseline over the past week
The NRS score ranges from 0 to 10, with higher scores indicating more severe pain.
week 5
The change from baseline in the Chinese version of the Insomnia Severity Index (ISI-C) scores.
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)."
week 5
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
The change in average 24h overall neck pain intensity measured by NRS from baseline over the past week
The NRS score ranges from 0 to 10, with higher scores indicating more severe pain.
week 9 and 16
The change from baseline in the ISI-C scores.
The 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)."
week 9 and 16
The proportion of participants with at least 30% reduction in NRS scores from baseline
The NRS score ranges from 0 to 10, with higher scores indicating more severe pain.
week 5, 9 and 16
The proportion of participants with at least 6 points reduction in ISI-C scores from baseline
The 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)."
week 5, 9 and 16
The change from baseline in the total score of the Neck Disability Index (NDI).
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.
week 5, 9 and 16
The proportion of participants with at least 10 points reduction in NDI scores from baseline
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.
week 5, 9 and 16
The change from baseline in the maximum pain intensity score on the NRS during six directions of neck movement.
The NRS score ranges from 0 to 10, with higher scores indicating more severe pain.
week 5, 9 and 16
The change from baseline in the Pittsburgh Sleep Quality Index (PSQI).
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.
week 5, 9 and 16
The change from baseline in the Hospital Anxiety and Depression Scale (HADS) scores.
The HADS score ranges from 0 to 42, with higher scores indicating greater anxiety and depression.
week 5, 9 and 16
The proportion of responders per the Patient Global Impression of Change (PGI-C)
The PGI-C evaluates the overall treatment effect perceived by patients themselves. The change can be rated in 7 levels, including "very much better", "moderately better, "a little better", "no change", "a little worse", "moderately worse" or "very much worse".
week 5 and 16
The percentage of patients who used rescue analgesics and sedative-hypnotics.
The percentage of patients who used emergency analgesics and sedative-hypnotics.
week 5, 9 and 16
The total number of days of using rescue analgesics and sedative-hypnotics.
The total number of days of using rescue analgesics and sedative-hypnotics.
week 5, 9 and 16
Blinding assessment
In this trial, two types of acupuncture treatments were used: traditional acupuncture, which has a stronger sensation of needle insertion, and modern acupuncture, which has a weaker sensation of needle insertion. Patients were asked which type of therapy they thought they had received.
Within 5 minutes after the last treatment at week 4.
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  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 24-hour overall neck pain intensity score on the NRS 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.

  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.
Guang'anmen Hospital of China Academy of Chinese Medical Sciences logoGuang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing University of Chinese Medicine logoBeijing University of Chinese Medicine
Study Responsible Party
Liu Zhishun, Principal Investigator, professer, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study Central Contact
Contact: Zhishun Liu, +861088002331, [email protected]
Contact: SIXING LIU, +8613521617871, [email protected]
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