Effect of Acupuncture on Chronic Nonspecific Neck Pain and Insomnia

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status: Not yet enrolling

Conditions: Neck Pain Chronic; Insomnia Chronic

Treatments: Device: sham acupuncture; Device: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT06996210

2025-090-KY

Details and patient eligibility

About

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

Enrollment: 124 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 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.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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124 participants in 2 patient groups

acupuncture group

Experimental group

Description:

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.

Treatment:

Device: Acupuncture

Sham acupuncture (SA) group

Sham Comparator group

Description:

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.

Treatment:

Device: sham acupuncture