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NCT Number: NCT06996210

Effect of Acupuncture on Chronic Nonspecific Neck Pain and Insomnia

The study aims to assess the efficacy and safety of acupuncture among patients with chronic nonspecific neck pain and insomnia, compared with sham acupuncture.

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Key information

Conditions

Neck Pain Chronic Dyssomnias Insomnia Chronic Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

acupuncture

Device

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 acupuncture

Device

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 outcomes

  1. 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.

  2. 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

  1. The change in average 24h overall neck pain intensity measured by NRS from baseline over the past week

    Time frame: week 9 and 16

    The NRS score ranges from 0 to 10, with higher scores indicating more severe pain.

  2. The change from baseline in the ISI-C scores.

    Time frame: week 9 and 16

    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)."

  3. The proportion of participants with at least 30% reduction in NRS scores from baseline

    Time frame: week 5, 9 and 16

    The NRS score ranges from 0 to 10, with higher scores indicating more severe pain.

  4. The proportion of participants with at least 6 points reduction in ISI-C scores from baseline

    Time frame: week 5, 9 and 16

    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)."

  5. The change from baseline in the total score of the Neck Disability Index (NDI).

    Time frame: 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.

  6. The proportion of participants with at least 10 points reduction in NDI scores from baseline

    Time frame: 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.

  7. The change from baseline in the maximum pain intensity score on the NRS during six directions of neck movement.

    Time frame: week 5, 9 and 16

    The NRS score ranges from 0 to 10, with higher scores indicating more severe pain.

  8. The change from baseline in the Pittsburgh Sleep Quality Index (PSQI).

    Time frame: 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.

  9. The change from baseline in the Hospital Anxiety and Depression Scale (HADS) scores.

    Time frame: week 5, 9 and 16

    The HADS score ranges from 0 to 42, with higher scores indicating greater anxiety and depression.

  10. The proportion of responders per the Patient Global Impression of Change (PGI-C)

    Time frame: week 5 and 16

    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".

  11. The percentage of patients who used rescue analgesics and sedative-hypnotics.

    Time frame: week 5, 9 and 16

    The percentage of patients who used emergency analgesics and sedative-hypnotics.

  12. The total number of days of using rescue analgesics and sedative-hypnotics.

    Time frame: week 5, 9 and 16

    The total number of days of using rescue analgesics and sedative-hypnotics.

  13. Blinding assessment

    Time frame: Within 5 minutes after the last treatment at week 4.

    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.

Other outcomes

  1. Expectance assessment

    Time frame: baseline

    Patients wIll be asked to predict how their chronic neck pain will change in one month (much better, somewhat better, uncertain, somewhat worse, much worse); and how their insomnia will change (much better, somewhat better, uncertain, somewhat worse, much worse).

  2. Incidence of advers events

    Time frame: through study completion, an average of 16 weeks

    Adverse events and severe adverse events will be recorded in the case report form, whether related to interventions or not.

Study contacts

Contact information is provided by the study sponsor or research team.

SIXING LIU

CONTACT

[email protected]

+8613521617871

Zhishun Liu

CONTACT

[email protected]

+861088002331

Sponsors and collaborators

Lead sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Other

Collaborators

  • Beijing University of Chinese Medicine

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
May 30, 2025
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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