Effect of Acupuncture on Chronic Nonspecific Neck Pain and Insomnia

Official title

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

Overview

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

Interventions

• Device 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.
• Device 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

• The change in average 24h overall neck pain intensity measured by NRS from baseline over the past week [Time frame: week 5]
• The change from baseline in the Chinese version of the Insomnia Severity Index (ISI-C) scores. [Time frame: week 5]

Secondary outcome measures (12)

• 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 change from baseline in the ISI-C scores. [Time frame: week 9 and 16]
• The proportion of participants with at least 30% reduction in NRS scores from baseline [Time frame: week 5, 9 and 16]
• The proportion of participants with at least 6 points reduction in ISI-C scores from baseline [Time frame: week 5, 9 and 16]
• The change from baseline in the total score of the Neck Disability Index (NDI). [Time frame: week 5, 9 and 16]
• The proportion of participants with at least 10 points reduction in NDI scores from baseline [Time frame: week 5, 9 and 16]
• 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 change from baseline in the Pittsburgh Sleep Quality Index (PSQI). [Time frame: week 5, 9 and 16]
• The change from baseline in the Hospital Anxiety and Depression Scale (HADS) scores. [Time frame: week 5, 9 and 16]
• The proportion of responders per the Patient Global Impression of Change (PGI-C) [Time frame: week 5 and 16]
• The percentage of patients who used rescue analgesics and sedative-hypnotics. [Time frame: week 5, 9 and 16]
• The total number of days of using rescue analgesics and sedative-hypnotics. [Time frame: week 5, 9 and 16]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Liu S, Chen H, Shen X, Lun H, Fan J, Wang W, Shi G, Liu Z. Acupuncture for Comorbid Chronic Nonspecific Neck Pain and Chronic Insomnia: Protocol for a Multicenter, Randomized, Sham-Controlled Trial. J Pain Res. 2026 Apr 17;19:598575. doi: 10.2147/JPR.S598575. eCollection 2026. PMID 42110592

Identifiers

NCT: NCT06996210 · 2025-090-KY

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗