Status:
NOT_YET_RECRUITING
Effect of Acupuncture on Chronic Nonspecific Neck Pain and Insomnia
Lead Sponsor:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborating Sponsors:
Beijing University of Chinese Medicine
Conditions:
Neck Pain Chronic
Insomnia Chronic
Eligibility:
All Genders
18-75 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 27 2028
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT06996210
Start Date
September 1 2025
End Date
March 27 2028
Last Update
July 15 2025
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