Clinical trial NCT06996210: Effect of Acupuncture on Chronic Nonspecific Neck Pain and Insomnia
Official title: Efficacy of Acupuncture in Treating Comorbid Chronic Nonspecific Neck Pain and Insomnia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Neck Pain Chronic
Insomnia Chronic
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: 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.
timeFrame: week 5
measure: The change from baseline in the Chinese version of the Insomnia Severity Index (ISI-C) scores.
timeFrame: week 5
Secondary outcomes:
measure: The change from baseline in the overall neck pain intensity score on the NRS over the last 3 days.
timeFrame: week 9 and 16
measure: The change from baseline in the ISI-C scores.
timeFrame: week 9 and 16
measure: The proportion of participants with at least 30% reduction in NRS scores from baseline
timeFrame: week 5, 9 and 16
measure: The proportion of participants with at least 6 points reduction in ISI-C scores from baseline
timeFrame: week 5, 9 and 16
measure: The change from baseline in the total score of the Neck Disability Index (NDI).
timeFrame: week 5, 9 and 16
measure: The proportion of participants with at least 10 points reduction in NDI scores from baseline
timeFrame: week 5, 9 and 16
measure: The change from baseline in the maximum pain intensity score on the NRS during six directions of neck movement.
timeFrame: week 5, 9 and 16
measure: The change from baseline in the Pittsburgh Sleep Quality Index (PSQI).
timeFrame: week 5, 9 and 16
measure: The change from baseline in the Hospital Anxiety and Depression Scale (HADS) scores.
timeFrame: week 5, 9 and 16
measure: The proportion of responders per the Patient Global Index of Improvement (PGI-I)
timeFrame: week 5and 16
measure: The percentage of patients who used rescue analgesics and sedative-hypnotics in the past week.
timeFrame: week 5, 9 and 16
measure: The total number of days of using rescue analgesics and sedative-hypnotics.
timeFrame: week 5, 9 and 16
measure: Blinding assessment
timeFrame: Within 5 minutes after the last treatment at week 4.
Other outcomes:
measure: Expectance assessment
timeFrame: baseline
measure: Incidence of advers events
timeFrame: through study completion, an average of 16 weeks
Locations:
Study officials:
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Zhishun Liu
role: PRINCIPAL_INVESTIGATOR
References: